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Monog raphs

Surg ical Mater ials

71-2

Absorbent Cotton

71-2 Absorbent Cotton revised 1/01 Absorbent Cotton complies with the requirements of the 3rd edition of

revised 1/01

Absorbent Cotton complies with the requirements of the 3rd edition of the European Pharmacopoeia [0036]. These requirements are reproduced after the heading ‘Definition’ below.

Ph Eur ___________________________________________________________________________________________________________

DEFINITION

Absorbent cotton consists of new fibres or good quality combers obtained from the seed-coat of various species of the genus Gossypium L., cleaned, purified, bleached and carefully carded. It may not contain any compensatory colouring matter.

CHARACTERS It is white and is composed of fibres of average length not less than 10 mm, determined by a suitable method, and contains not more than traces of leaf residue, pericarp, seed-coat or other impurities. It offers appreciable resistance when pulled. It does not shed any appreciable quantity of dust when gently shaken.

IDENTIFICATION

  • A. Examined under a microscope, each fibre is seen to consist of a single cell, up to about 4 cm long

and up to 40 µm wide, in the form of a flattened tube with thick and rounded walls and often twisted.

  • B. When treated with iodinated zinc chloride solution R, the fibres become violet.

  • C. To 0.1 g add 10 ml of zinc chloride-formic acid solution R. Heat to 40°C and allow to stand for 2 h

    • 30 min, shaking occasionally. It does not dissolve.

TESTS

Solution S Place 15.0 g in a suitable vessel, add 150 ml of water R, close the vessel and allow to macerate for 2 h. Decant the solution, squeeze the residual liquid carefully from the sample with a glass rod and mix. Reserve 10 ml of the solution for the test for surface-active substances and filter the remainder.

Acidity or alkalinity To 25 ml of solution S add 0.1 ml of phenolphthalein solution R and to another

  • 25 ml add 0.05 ml of methyl orange solution R. Neither solution is pink.

Foreign fibres Examined under a microscope, it is seen to consist exclusively of typical cotton fibres, except that occasionally a few isolated foreign fibres may be present.

Fluorescence Examine a layer about 5 mm in thickness under ultraviolet light at 365 nm. It displays only a slight brownish-violet fluorescence and a few yellow particles. It shows no intense blue fluores- cence, apart from that which may be shown by a few isolated fibres.

Neps Spread about 1 g evenly between two colourless transparent plates each 10 cm square. Exam- ine for neps by transmitted light and compare with Absorbent cotton RM. The product to be examined is not more neppy than the standard.

Absorbency

Apparatus. A dry cylindrical copper wire basket 8.0 cm high and 5.0 cm in diameter. The wire of which the basket is constructed is about 0.4 mm in diameter, the mesh is 1.5 cm to 2.0 cm wide and the mass of the basket is 2.7 ± 0.3 g.

Sinking time. Not more than 10 s. Weigh the basket to the nearest centigram (m 1 ). Take a total of 5.00 g in approximately equal quantities from five different places in the product to be examined, place loosely in the basket and weigh the filled basket to the nearest centigram (m 2 ). Fill a beaker

  • 11 cm to 12 cm in diameter to a depth of 10 cm with water at about 20°C. Hold the basket

horizontally and drop it from a height of about 10 mm into the water. Measure with a stopwatch the time taken for the basket to sink below the surface of the water. Calculate the result as the average of

three tests.

Water-holding capacity. Not less than 23.0 g of water per gram. After the sinking time has been measured, remove the basket from the water, allow it to drain for exactly 30 s suspended in a horizontal position over the beaker, transfer it to a tared beaker (m 3 ) and weigh to the nearest centigram (m 4 ). Calculate the water-holding capacity per gram of absorbent cotton using the follow- ing expression:

m

4

(

m

2

+

m

3

)

m Calculate the result as the average of three tests. Ether-soluble substances Not more than 0.50 per cent. In an extraction apparatus, extract 5.00 g

2

m

1

71-3

with ether R for 4 h at a rate of at least four extractions per hour. Evaporate the ether extract and dry the residue to constant mass at 100°C to 105°C.

Extractable colouring matter In a narrow percolator, slowly extract 10.0 g with alcohol R until

  • 50 ml of extract is obtained. The liquid obtained is not more intensely coloured (Method II, 2.2.2)

than reference solution Y 5 , GY 6 or a reference solution prepared as follows: to 3.0 ml of blue primary solution add 7.0 ml of hydrochloric acid (10 g/l HCl). Dilute 0.5 ml of this solution to 10.0 ml with hydrochloric acid (10 g/l HCl).

Surface-active substances Introduce the 10 ml portion of solution S reserved before filtration into a 25 ml graduated ground-glass-stoppered cylinder with an external diameter of 20 mm and a wall thickness of not greater than 1.5 mm, previously rinsed three times with sulphuric acid R and then with water R. Shake vigorously thirty times in 10 s, allow to stand for 1 min and repeat the shaking. After 5 min, any foam present must not cover the entire surface of the liquid.

Water-soluble substances Not more than 0.50 per cent. Boil 5.000 g in 500 ml of water R for

  • 30 min, stirring frequently. Replace the water lost by evaporation. Decant the liquid, squeeze the

residual liquid carefully from the sample with a glass rod and mix. Filter the liquid whilst hot. Evaporate 400 ml of the filtrate (corresponding to 4/5 of the mass of the sample taken) and dry the residue to constant mass at 100°C to 105°C.

Loss on drying (2.2.32). Not more than 8.0 per cent, determined 5.000 g by drying in an oven at 100°C to 105°C.

Sulphated ash (2.4.14). Not more than 0.40 per cent. Introduce 5.00 g into a previously heated and cooled, tared crucible. Heat cautiously over a naked flame and then carefully to dull redness at 600°C. Allow to cool, add a few drops of dilute sulphuric acid R, then heat and incinerate until all the black particles have disappeared. Allow to cool. Add a few drops of ammonium carbonate solution R. Evaporate and incinerate carefully, allow to cool and weigh again. Repeat the incineration for periods of 5 min to constant mass.

STORAGE Store in a dust-proof package in a dry place.

Ph Eur

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71-4

Absorbent Viscose Wadding

71-4 Absorbent Viscose Wadding revised 1/01 Absorbent Viscose Wadding complies with the requirements of the 3rd

revised 1/01

Absorbent Viscose Wadding complies with the requirements of the 3rd edition of the European Pharmacopoeia [0034]. These requirements are reproduced after the heading Definitionbelow.

Ph Eur ___________________________________________________________________________________________________________

DEFINITION

Absorbent viscose wadding consists of bleached, carefully carded, new fibres of regenerated cellulose obtained by the viscose process, with or without the addition of titanium dioxide, of linear density 1.0 dtex to 8.9 dtex (dtex = mass of 10,000 m of fibre, expressed in grams) and cut to a suitable staple length. It does not contain any compensatory colouring matter.

CHARACTERS It is white or very slightly yellow, has a lustrous or matt appearance, and is soft to the touch.

IDENTIFICATION

  • A. Viscose rayon fibres may be solid or hollow; hollow fibres may have a continuous lumen or be

compartmented. The fibres have an average length of 25 mm to 80 mm and when examined under a microscope in the dry state, or when mounted in alcohol R and water R, the following characters are observed. They are usually of a more or less uniform width, with many longitudinal parallel lines distributed unequally over the width. The ends are cut more or less straight. Matt fibres contain numerous granular particles of approximately 1 µm average diameter.

Solid fibres. In longitudinal view, the surface of the fibres may be uneven or crenate. Fibres having an approximately circular or elliptical cross section have a diameter of about 10 µm to 20 µm and those that are flattened and twisted ribbons vary in width from 15 µm to 20 µm as the twisting of the filament reveals first the major axis and then the minor axis. They are about 4 µm in thickness. Other solid cross sections are Y-shaped and have protruding limbs with the major axis 5 µm to 25 µm in length and the minor axis 2 µm to 8 µm wide.

Hollow fibres. Fibres with a continuous, hollow lumen have a diameter of up to about 30 µm; they are thin-walled, with a wall thickness of about 5 µm. When mounted in alcohol R and water R, the lumen is clearly indicated in many fibres by the presence of many entrapped air bubbles.

Compartmented fibres. These fibres may have a diameter of up to 80 µm; they are hollow, having a central lumen which is divided up into several compartments. Individual compartments vary in size but typically may be up to about 60 µm in length and there may be more than one compartment across the width of each fibre. Some compartments show entrapped air bubbles when the fibres are mounted in alcohol R and water R.

  • B. When treated with iodinated zinc chloride solution R, the fibres become violet.

  • C. To 0.1 g add 10 ml of zinc chloride-formic acid solution R. Heat to 40°C and allow to stand for 2 h

    • 30 min, shaking occasionally. It dissolves completely except for the matt variety where titanium

dioxide particles remain.

  • D. Dissolve the residue obtained in the test for sulphated ash by warming gently with 5 ml of

sulphuric acid R. Allow to cool and add 0.2 ml of dilute hydrogen peroxide solution R. The solution

obtained from the lustrous variety undergoes no change in colour; that from the matt variety shows an orange-yellow colour, the intensity of which depends on the quantity of titanium dioxide present.

TESTS

Solution S Place 15.0 g in a suitable vessel, add 150 ml of water R, close the vessel and allow to macerate for 2 h. Decant the solution, squeeze the residual liquid carefully from the sample with a glass rod and mix. Reserve 10 ml of the solution for the test for surface-active substances and filter the remainder.

Acidity or alkalinity To 25 ml of solution S add 0.1 ml of phenolphthalein solution R and to another

  • 25 ml add 0.05 ml of methyl orange solution R. Neither solution is pink.

Foreign fibres Examined under a microscope, it is seen to consist exclusively of viscose fibres, except that occasionally a few isolated foreign fibres may be present. Fluorescence Examine a layer about 5 mm in thickness under ultraviolet light at 365 nm. It displays only a slight brownish-violet fluorescence. It shows no intense blue fluorescence, apart from that which may be shown by a few isolated fibres. Absorbency Apparatus. A dry cylindrical copper-wire basket 8.0 cm high and 5.0 cm in diameter. The wire of

71-5

which the basket is constructed is about 0.4 mm in diameter, the mesh is 1.5 cm to 2.0 cm wide and the mass of the basket is 2.7 ± 0.3 g.

Sinking time. Not more than 10 s. Weigh the basket to the nearest centigram (m 1 ). Take a total of 5.00 g in approximately equal quantities from five different places in the product to be examined, place loosely in the basket and weigh the filled basket to the nearest centigram (m 2 ). Fill a beaker

  • 11 cm to 12 cm in diameter to a depth of 10 cm with water at about 20°C. Hold the basket

horizontally and drop it from a height of about 10 mm into the water. Measure with a stopwatch the time taken for the basket to sink below the surface of the water. Calculate the result as the average of three tests.

Water-holding capacity. Not less than 18.0 g of water per gram. After the sinking time has been measured, remove the basket from the water, allow it to drain for exactly 30 s suspended in a horizontal position over the beaker, transfer it to a tared beaker (m 3 ) and weigh to the nearest centigram (m 4 ). Calculate the water-holding capacity per gram of absorbent viscose wadding using the following expression:

m

4

(

m

2

+

m

3

)

m

2

m

1

Calculate the result as the average of three tests.

Ether-soluble substances Not more than 0.30 per cent. In an extraction apparatus, extract 5.00 g with ether R for 4 h at a rate of at least four extractions per hour. Evaporate the ether extract and dry the residue to constant mass at 100°C to 105°C.

Extractable colouring matter In a narrow percolator, slowly extract 10.0 g with alcohol R until

  • 50 ml of extract is obtained. The liquid obtained is not more intensely coloured (Method II, 2.2.2)

than reference solution Y 5 , GY 6 or a reference solution prepared as follows: to 3.0 ml of blue primary solution add 7.0 ml of hydrochloric acid (10 g/l HCl) and dilute 0.5 ml of this solution to 10.0 ml with hydrochloric acid (10 g/l HCl).

Surface-active substances Introduce the 10 ml portion of solution S reserved before filtration into a 25 ml graduated ground-glass-stoppered cylinder with an external diameter of 20 mm and a wall thickness of not greater than 1.5 mm, previously rinsed three times with sulphuric acid R and then with water R. Shake vigorously thirty times in 10 s, allow to stand for 1 min and repeat the shaking. After 5 min, any foam present does not cover the entire surface of the liquid.

Water-soluble substances Not more than 0.70 per cent. Boil 5.00 g in 500 ml of water R for

  • 30 min, stirring frequently. Replace the water lost by evaporation. Decant the liquid, squeeze the

residual liquid carefully from the sample with a glass rod and mix. Filter the liquid whilst hot. Evaporate 400 ml of the filtrate (corresponding to 4/5 of the mass of the sample taken) and dry the residue to constant mass at 100°C to 105°C.

Hydrogen sulphide To 10 ml of solution S add 1.9 ml of water R, 0.15 ml of dilute acetic acid R and 1 ml of lead acetate solution R. After 2 min, the solution is not more intensely coloured than a refer- ence solution prepared at the same time using 0.15 ml of dilute acetic acid R, 1.2 ml of thioacetamide reagent R, 1.7 ml of lead standard solution (10 ppm Pb) R and 10 ml of solution S.

Loss on drying (2.2.32). Not more than 13.0 per cent, determined on 5.000 g by drying in an oven at 100°C to 105°C.

Sulphated ash (2.4.14). Not more than 0.45 per cent for the lustrous variety and not more than 1.7 per cent for the matt variety. Introduce 5.00 g into a previously heated and cooled, tared crucible. Heat cautiously over a naked flame and then carefully to dull redness at 600°C. Allow to cool, add a few drops of dilute sulphuric acid R, then heat and incinerate until all the black particles have disappeared. Allow to cool. Add a few drops of ammonium carbonate solution R. Evaporate and incinerate carefully, allow to cool and weigh again. Repeat the incineration for periods of 5 min to constant mass.

STORAGE Store in a dust-proof package in a dry place.

Ph Eur

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71-6

SUTURES

71-6 SUTURES Sutures comply with the requirements of the third edition of the European Pharmacopoeia. The

Sutures comply with the requirements of the third edition of the European Pharmacopoeia. The introduction to these requirements is reproduced below.

Ph Eur ___________________________________________________________________________________________________________

INTRODUCTION

The following monographs apply to sutures for human use: Catgut, sterile (0317), Sutures, sterile non- absorbable (0324), Sutures, sterile synthetic absorbable braided (0667) and Sutures, sterile synthetic absorbable monofilament (0666). They cover performance characteristics of sutures and may include methods of identification. Sutures are medical devices as defined in Directive 93/42/EEC.

These monographs can be applied to show compliance with essential requirements as defined in Article 3 of Directive 93/42/EEC covering the following:

Physical performance characteristics: diameter, breaking load, needle attachment, packaging, sterility, information supplied by the manufacturer (see Section 13 of Annex 1 of Directive 93/42/EEC), labelling.

To show compliance with other essential requirements, the application of appropriate harmonised standards as defined in Article 5 of Directive 93/42/EEC may be considered.

Ph Eur

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71-7

Sterile Catgut

71-7 Sterile Catgut Sterile Catgut complies with the requirements of the 3rd edition of the European

Sterile Catgut complies with the requirements of the 3rd edition of the European Pharmacopoeia [0317]. These requirements are reproduced after the heading Definitionbelow.

Ph Eur ___________________________________________________________________________________________________________

DEFINITION

Sterile catgut consists of sutures prepared from collagen taken from the intestinal membranes of mammals. After cleaning, the membranes are split longitudinally into strips of varying width, which, when assembled in small numbers, according to the diameter required, are twisted under tension, dried, polished, selected and sterilised. The sutures may be treated with chemical substances such as chromium salts to prolong absorption and glycerol to make them supple, provided such substances do not reduce tissue acceptability. Appropriate harmonised standards may be considered when assessing compliance with respect to origin and processing of raw materials and with respect to biocompatibility. Sterile catgut is a surgical wound-closure device. Being an absorbable suture it serves to approximate tissue during the healing period and is subsequently metabolised by proteolytic activity.

PRODUCTION

Appropriate harmonised standards may apply with respect to appropriate validated methods of sterilisation, environmental control during manufacturing, labelling and packaging. It is essential for the effectiveness and the performance characteristics during use and during the functional lifetime of catgut that the following physical properties are specified: consistent diameter, sufficient initial strength and firm needle attachment. The requirements outlined below have been established, taking into account stresses which occur during normal conditions of use. These requirements can be used to demonstrate that individual production batches of sterile catgut are suitable for wound closure according to usual surgical techniques.

TESTS

If stored in a preserving liquid, remove the sutures from the sachet and measure promptly and in succession the length, diameter and breaking load. If stored in the dry state, immerse the sutures in alcohol R or a 90 per cent V/V solution of 2-propanol R for 24 h and proceed with the measurements as indicated below.

Length Measure the length without applying to the suture more tension than is necessary to keep it straight. The length of each suture is not less than 90 per cent of the length stated on the label and does not exceed 350 cm.

Diameter Carry out the test on five sutures. Use a suitable instrument capable of measuring with an accuracy of at least 0.002 mm and having a circular pressor foot 10 mm to 15 mm in diameter. The pressor foot and the moving parts attached to it are weighted so as to apply a total load of 100 ± 10 g to the suture being tested. When making the measurement, lower the pressor foot slowly to avoid crushing the suture. Measure the diameter at intervals of 30 cm over the whole length of the suture. For a suture less than 90 cm in length, measure at three points approximately evenly spaced along the suture. The suture is not subjected to more tension than is necessary to keep it straight during measurement. The average of the measurements carried out on the sutures being tested and not less than two-thirds of the measurements taken on each suture are within the limits given in the columns under A in Table 3171 for the gauge number concerned. None of the measurements is outside the limits given in the columns under B in Table 3171 for the gauge number concerned.

71-8

Table 3171 Diameters and Breaking Loads

Gauge

Diameter (millimetres)

 

Breaking load

number

(newtons)

 
 

A

B

CD

 

min.

max.

min.

max.

  • 0.1 0.010

 

0.019

0.005

0.025

  • 0.2 0.020

0.029

0.015

0.035

  • 0.3 0.030

0.039

0.025

0.045

0.20

0.05

  • 0.4 0.040

0.049

0.035

0.060

0.30

0.10

  • 0.5 0.050

0.069

0.045

0.085

0.40

0.20

  • 0.7 0.070

0.099

0.060

0.125

0.70

0.30

1

0.100

0.149

0.085

0.175

1.8

0.40

1.5

0.150

0.199

0.125

0.225

3.8

0.70

2

0.200

0.249

0.175

0.275

7.5

1.8

2.5

0.250

0.299

0.225

0.325

10

3.8

3

0.300

0.349

0.275

0.375

12.5

7.5

3.5

0.350

0.399

0.325

0.450

20

10

  • 4 0.400

 

0.499

0.375

0.550

27.5

12.5

  • 5 0.500

0.599

0.450

0.650

38.0

20.0

  • 6 0.600

0.699

0.550

0.750

45.0

27.5

  • 7 0.700

0.799

0.650

0.850

60.0

38.0

  • 8 0.800

0.899

0.750

0.950

70.0

45.0

Minimum breaking load The minimum breaking load is determined over a simple knot formed by placing one end of a suture held in the right hand over the other end held in the left hand, passing one end over the suture and through the loop so formed (see Fig. 3171) and pulling the knot tight. Carry out the test on five sutures. Submit sutures of length greater than 75 cm to two measurements and shorter sutures to one measurement. Determine the breaking load using a suitable tensilometer. The apparatus has two clamps for holding the suture, one of which is mobile and is driven at a constant rate of 30 cm per minute. The clamps are designed so that the suture being tested can be attached without any possibility of slipping. At the beginning of the test the length of suture between the clamps is 12.5 cm to 20 cm and the knot is midway between the clamps. Set the mobile clamp in motion and note the force required to break the suture. If the suture breaks in a clamp or within 1 cm of it, the result is discarded and the test repeated on another suture. The average of all the results, excluding those legitimately discarded, is equal to or greater than the value given in column C in Table 3171 and no individual result is less than that given in column D for the gauge number concerned.

71-8 Table 317 – 1 Diameters and Breaking Loads Gauge Diameter (millimetres) Breaking load number (newtons)

Fig. 317–1 Simple knot

Soluble chromium compounds Place 0.25 g in a conical flask containing 1 ml of water R per 10 mg of catgut. Stopper the flask, allow to stand at 37 ± 0.5°C for 24 h, cool and decant the liquid. Transfer 5 ml to a small test tube and add 2 ml of a 10 g/l solution of diphenylcarbazide R in alcohol R and 2 ml of dilute sulphuric acid R. The solution is not more intensely coloured than a standard prepared at the same time using 5 ml of a solution containing 2.83 µg of potassium dichromate R per millilitre, 2 ml of dilute sulphuric acid R and 2 ml of a 10 g/l solution of diphenylcarbazide R in alcohol R (1 ppm of Cr).

Needle attachment If the catgut is supplied with an eyeless needle attached that is not stated to be detachable, it complies with the test for needle attachment. Carry out the test on five sutures. Use a suitable tensilometer, such as that described for the determination of the minimum breaking load. Fix the needle and suture (without knot) in the clamps of the apparatus in such a way that the swaged

71-9

part of the needle is completely free of the clamp and in line with the direction of pull on the suture. Set the mobile clamp in motion and note the force required to break the suture or to detach it from the needle. The average of the five determinations and all individual values are not less than the respective values given in Table 317-2 for the gauge number concerned. If not more than one individual value fails to meet the individual requirement, repeat the test on an additional ten sutures. The catgut complies with the test if none of these ten values is less than the individual value in Table 3172 for the gauge number concerned.

Table 3172 Minimum Strengths of Needle Attachment

Gauge

Mean value

Individual values

number

(newtons)

(newtons)

  • 0.5 0.50

0.25

  • 0.7 0.80

0.40

1

1.7

0.80

1.5

2.3

1.1

2

4.5

2.3

2.5

5.6

2.8

3

6.8

3.4

3.5

11.0

4.5

  • 4 15.0

4.5

  • 5 18.0

6.0

STORAGE (PACKAGING)

Sterile catgut sutures are presented in individual sachets that maintain sterility and allow the withdrawal and use of the sutures in aseptic conditions. Sterile catgut may be stored dry or in a preserving liquid to which an antimicrobial agent but not an antibiotic may be added. Sutures in their individual sachets (primary packaging) are kept in a protective cover (box) which maintains the physical and mechanical properties until the time of use. The application of appropriate harmonised standards for packaging of medical devices shall be considered.

LABELLING

Reference may be made to the appropriate harmonised standards for labelling of medical devices. The details strictly necessary for the user to identify the product properly are indicated on or in each sachet (primary packaging) and on the protective cover (box) and include at least:

gauge number, length in centimetres or metres, if appropriate, that the needle is detachable, name of the product, intended use (surgical suture, absorbable).

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71-10

Sterile Synthetic Absorbable Braided Sutures

71-10 Sterile Synthetic Absorbable Braided Sutures Sterile Synthetic Absorbable Braided Sutures comply with the requirements of

Sterile Synthetic Absorbable Braided Sutures comply with the requirements of the 3rd edition of the European Pharmacopoeia [0667]. These requirements are reproduced after the heading Definitionbelow.

Ph Eur

.

___________________________________________________________________________________________________________

DEFINITION

Sterile synthetic absorbable braided sutures consist of sutures prepared from a synthetic polymer, polymers or copolymers which, when introduced into a living organism, are absorbed by that organism and cause no undue tissue irritation. They consist of completely polymerised material. They occur as multifilament sutures consisting of elementary fibres which are assembled by braiding. The sutures may be treated to facilitate handling and they may be coloured. Appropriate harmonised standards may be considered when assessing compliance with respect to origin and processing of raw materials and with respect to biocompatibility. Sterile synthetic absorbable braided sutures are wound-closure devices. Being absorbable they serve to approximate tissue during the healing period and subsequently lose tensile strength by hydrolysis.

PRODUCTION

Appropriate harmonised standards may apply with respect to appropriate validated methods of sterilisation, environmental control during manufacturing, labelling and packaging. It is essential for the effectiveness and the performance characteristics during use and during the functional lifetime of these sutures that the following physical properties are specified: consistent diameter, sufficient initial strength and firm needle attachment. The requirements below have been established, taking into account stresses which occur during normal conditions of use. These requirements can be used to demonstrate that individual production batches of these sutures are suitable for wound closure according to usual surgical techniques.

TESTS

Carry out the following tests on the sutures in the state in which they are removed from the sachet.

Length Measure the length of the suture without applying more tension than is necessary to keep it straight. The length of each suture is not less than 95 per cent of the length stated on the label and does not exceed 400 cm.

Diameter Unless otherwise prescribed, measure the diameter by the following method, using five sutures in the condition in which they are presented. Use a suitable instrument capable of measuring with an accuracy of at least 0.002 mm and having a circular pressor foot 10 mm to 15 mm in diameter. The pressor foot and the moving parts attached to it are weighted so as to apply a total load of 100 ± 10 g to the suture being tested. When making the measurements, lower the pressor foot slowly to avoid crushing the suture. Measure the diameter at intervals of 30 cm over the whole length of the suture. For a suture less than 90 cm in length, measure at three points approximately evenly spaced along the suture. During the measurement, submit the sutures to a tension not greater than one-fifth of the minimum breaking load shown in column C of Table 6671 appropriate to the gauge number and type of material or 10 N whichever is the less. For sutures of gauge number above 1.5 make two measurements at each point, the second measurement being made after rotating the suture through 90°. The diameter of that point is the average of the two measurements. The average of the measurements carried out on the sutures being tested and not less than two-thirds of the measure- ments taken on each suture are within the limits given in the columns under A in Table 6671 for the gauge number concerned. None of the measurements is outside the limits given in the columns under B in Table 6671 for the gauge number concerned.

71-11

Table 6671 Diameters and Breaking Loads

Gauge

Diameter (millimetres)

 

Breaking load

number

(newtons)

 
 

A

B

CD

 

min.

max.

min.

max.

  • 0.01 0.001

 

0.004

0.008

0.005

  • 0.05 0.005

0.009

0.003

0.012

  • 0.1 0.010

0.019

0.005

0.025

  • 0.2 0.020

0.029

0.015

0.035

  • 0.3 0.030

0.039

0.025

0.045

0.45

0.23

  • 0.4 0.040

0.049

0.035

0.060

0.70

0.35

  • 0.5 0.050

0.069

0.045

0.085

1.4

0.7

  • 0.7 0.070

0.099

0.060

0.125

2.5

1.3

1

0.100

0.149

0.085

0.175

6.8

3.4

1.5

0.150

0.199

0.125

0.225

9.5

4.8

2

0.200

0.249

0.175

0.275

17.7

8.9

2.5

0.250

0.299

0.225

0.325

21.0

10.5

3

0.300

0.349

0.275

0.375

26.8

13.4

3.5

0.350

0.399

0.325

0.450

39.0

18.5

  • 4 0.400

 

0.499

0.375

0.550

50.8

25.4

  • 5 0.500

0.599

0.450

0.650

63.5

31.8

  • 6 0.600

0.699

0.550

0.750

  • 7 0.700

0.799

0.650

0.850

Minimum breaking load The minimum breaking load is determined over a simple knot formed by placing one end of a suture held in the right hand over the other end held in the left hand, passing one end over the suture and through the loop so formed (see Fig. 6671) and pulling the knot tight.

71-11 Table 667 – 1 Diameters and Breaking Loads Gauge Diameter (millimetres) Breaking load number (newtons)

Fig. 667–1 Simple knot

Carry out the test on five sutures. Submit sutures of length greater than 75 cm to two measurements and shorter sutures to one measurement. Determine the breaking load using a suitable tensilometer. The apparatus has two clamps for holding the suture, one of which is mobile and is driven at a constant rate of 25 cm to 30 cm per minute. The clamps are designed so that the suture being tested can be attached without any possibility of slipping. At the beginning of the test the length of suture between the clamps is 12.5 cm to 20 cm and the knot is midway between the clamps. Set the mobile clamp in motion and note the force required to break the suture. If the suture breaks in a clamp or within 1 cm of it, the result is discarded and the test repeated on another suture. The average of all the results excluding those legitimately discarded is equal to or greater than the value given in column C in Table 6671 and no individual result is less than that given in column D for the gauge number concerned.

Needle attachment If the suture is supplied with an eyeless needle attached that is not stated to be detachable the attachment, it complies with the test for needle attachment. Carry out the test on five sutures. Use a suitable tensilometer, such as that described for the determination of the minimum breaking load. Fix the needle and suture (without knot) in the clamps of the apparatus in such a way that the swaged part of the needle is completely free of the clamp and in line with the direction of pull on the suture. Set the mobile clamp in motion and note the force required to break the suture or to detach it from the needle. The average of the five determinations and all individual values are not less than the respective values given in Table 6672 for the gauge number concerned. If not more than one individual value fails to meet the individual requirement, repeat the test on an additional ten sutures. The attachment complies with the test if none of the ten values is less than the individual value in Table 6672 for the gauge number concerned.

71-12

Table 6672 Minimum Strengths of Needle Attachment

Gauge

Mean value

Individual value

number

(newtons)

(newtons)

  • 0.4 0.50

0.25

  • 0.5 0.80

0.40

  • 0.7 1.7

0.80

1

2.3

1.1

1.5

4.5

2.3

2

6.8

3.4

2.5

9.0

4.5

3

11.0

4.5

3.5

15.0

4.5

  • 4 18.0

6.0

  • 5 18.0

7.0

STORAGE (PACKAGING)

Sterile synthetic absorbable braided sutures are presented in a suitable sachet that maintains sterility and allows the withdrawal and use of the sutures in aseptic conditions. The sutures must be stored dry. They are intended to be used only on the occasion when the sachet is first opened. Sutures in their individual sachets (primary packaging) are kept in a protective cover (box) which maintains the physical and mechanical properties until the time of use. The application of appropriate harmonised standards for packaging of medical devices may be considered in addition.

LABELLING

Reference may be made to the appropriate harmonised standards for the labelling of medical devices. The details strictly necessary for the user to identify the product properly are indicated on or in each sachet (primary packaging) and on the protective cover (box) and include at least:

gauge number, length in centimetres or metres, if appropriate, that the needle is detachable, name of the product, intended use (surgical absorbable suture), if appropriate, that the suture is coloured, the structure (braided).

Ph Eur

__________________________________________________________________________________________________________

71-13

Sterile Synthetic Absorbable Monofilament Sutures

71-13 Sterile Synthetic Absorbable Monofilament Sutures Sterile Synthetic Absorbable Monofilament Sutures comply with the requirements of

Sterile Synthetic Absorbable Monofilament Sutures comply with the requirements of the 3rd edition of the European Pharmacopoeia [0666]. These requirements are reproduced after the heading Definitionbelow.

Ph Eur ___________________________________________________________________________________________________________

DEFINITION

Sterile synthetic absorbable monofilament sutures consist of sutures prepared from a synthetic poly- mer, polymers or copolymers which, when introduced into a living organism, are absorbed by that organism and cause no undue tissue irritation. They consist of completely polymerised material. They occur as monofilament sutures. The sutures may be treated to facilitate handling and they may be coloured. Appropriate harmonised standards may be considered when assessing compliance with respect to origin and processing of raw materials and with respect to biocompatibility. Sterile synthetic absorbable monofilament sutures are wound-closure devices. Being absorbable they serve to approximate tissue during the healing period and subsequently lose tensile strength by hydrolysis.

PRODUCTION

The appropriate harmonised standards may apply with respect to appropriate validated methods of sterilisation, environmental control during manufacturing, labelling and packaging. It is essential for the effectiveness and the performance characteristics during use and during the functional lifetime of these sutures that the following physical properties are specified: consistent diameter, sufficient initial strength and firm needle attachment. The requirements below have been established, taking into account stresses which occur during normal conditions of use. These requirements can be used to demonstrate that individual production batches of these sutures are suitable for wound closure according to usual surgical techniques.

TESTS

Carry out the following tests on the sutures in the state in which they are removed from the sachet.

Length Measure the length of the suture without applying more tension than is necessary to keep it straight. The length of each suture is not less than 95 per cent of the length stated on the label and does not exceed 400 cm.

Diameter Unless otherwise prescribed, measure the diameter by the following method, using five sutures in the condition in which they are presented. Use a suitable instrument capable of measuring with an accuracy of at least 0.002 mm and having a circular pressor foot 10 mm to 15 mm in diameter. The pressor foot and the moving parts attached to it are weighted so as to apply a total load of 100 ± 10 g to the suture being tested. When making the measurements, lower the pressor foot slowly to avoid crushing the suture. Measure the diameter at intervals of 30 cm over the whole length of the suture. For a suture less than 90 cm in length, measure at three points approximately evenly spaced along the suture. During the measurement, submit the sutures to a tension not greater than that required to keep them straight. The average of the measurements carried out on the sutures being tested and not less than two-thirds of the measurements taken on each suture are within the limits given in the columns under A in Table 666-1 for the gauge number concerned. None of the measurements is outside the limits given in the columns under B in Table 666-1 for the gauge number concerned.

Table 6661 Diameters and Breaking Loads

Gauge

Diameter (millimetres)

 

Breaking load

number

(newtons)

 
 

A

B

CD

 

min.

max.

min.

max.

  • 0.5 0.050

 

0.094

0.045

0.125

1.4

0.7

  • 0.7 0.095

0.149

0.075

0.175

2.5

1.3

1

0.150

0.199

0.125

0.225

6.8

3.4

1.5

0.200

0.249

0.175

0.275

9.5

4.7

  • 2 0.250

 

0.339

0.225

0.375

17.5

8.9

  • 3 0.340

0.399

0.325

0.450

26.8

13.4

3.5

0.400

0.499

0.375

0.550

39.0

18.5

  • 4 0.500

 

0.570

0.450

0.600

50.8

25.4

  • 5 0.571

0.610

0.500

0.700

63.5

31.8

71-14

Minimum breaking load The minimum breaking load is determined over a simple knot formed by placing one end of a suture held in the right hand over the other end held in the left hand, passing one end over the suture and through the loop so formed (see Figure 6661) and pulling the knot tight.

71-14 Minimum breaking load The minimum breaking load is determined over a simple knot formed by

Fig. 666–1 Simple knot

Carry out the test on five sutures. Submit sutures of length greater than 75 cm to two measurements and shorter sutures to one measurement. Determine the breaking load using a suitable tensilometer. The apparatus has two clamps for holding the suture, one of which is mobile and is driven at a constant rate of 25 cm to 30 cm per minute. The clamps are designed so that the suture being tested can be attached without any possibility of slipping. At the beginning of the test the length of suture between the clamps is 12.5 cm to 20 cm and the knot is midway between the clamps. Set the mobile clamp in motion and note the force required to break the suture. If the suture breaks in a clamp or within 1 cm of it, the result is discarded and the test repeated on another suture. The average of all the results excluding those legitimately discarded is equal to or greater than the value given in column C in Table 6661 and no individual result is less than that given in column D for the gauge number concerned.

Needle attachment If the suture is supplied with an eyeless needle attached that is not stated to be detachable, the attachment complies with the test for needle attachment. Carry out the test on five sutures. Use a suitable tensilometer, such as that described for the determination of the minimum breaking load. Fix the needle and suture (without knot) in the clamps of the apparatus in such a way that the swaged part of the needle is completely free of the clamp and in line with the direction of pull on the suture. Set the mobile clamp in motion and note the force required to break the suture or to detach it from the needle. The average of the five determinations and all individual values are not less than the respective values given in Table 6662 for the gauge number concerned. If not more than one individual value fails to meet the individual requirement, repeat the test on an additional ten sutures. The attachment complies with the test if none of the ten values is less than the individual value in Table 6662 for the gauge number concerned.

Table 6662 Minimum Strengths of Needle Attachment

Gauge

Mean value

Individual value

number

(newtons)

(newtons)

  • 0.5 0.40

0.80

  • 0.7 0.80

1.7

1

2.3

1.1

1.5

4.5

2.3

2

6.8

3.4

2.5

9.0

4.5

3

11.0

4.5

3.5

15.0

4.5

  • 4 6.0

18.0

  • 5 7.0

18.0

STORAGE (PACKAGING)

Sterile synthetic absorbable monofilament sutures are presented in a suitable sachet that maintains sterility and allows the withdrawal and use of the sutures in aseptic conditions. The sutures must be stored dry. They are intended to be used only on the occasion when the sachet is first opened. Sutures in their individual sachets (primary packaging) are kept in a protective cover (box) which maintains the physical and mechanical properties until the time of use. The application of appropriate harmonised standards for packaging of medical devices may be considered in addition.

71-15

LABELLING

Reference may be made to appropriate harmonised standards for the labelling of medical devices. The details strictly necessary for the user to identify the product properly are indicated on or in each sachet (primary packaging) and on the protective cover (box) and include at least:

gauge number, length in centimetres or metres, if appropriate, that the needle is detachable, name of the product, intended use (surgical absorbable suture), if appropriate, that the suture is coloured, the structure (monofilament).

Ph Eur

__________________________________________________________________________________________________________

71-16

Sterile Non-absorbable Sutures

Sterile Non-absorbable Ligatures

71-16 Sterile Non-absorbable Sutures Sterile Non-absorbable Ligatures Sterile Braided Silk Suture, Sterile Linen Thread (Suture), Sterile

Sterile Braided Silk Suture, Sterile Linen Thread (Suture), Sterile Polyethylene Terephthalate (Polyester) Suture, Sterile Polyamide 6 Suture, Sterile Polyamide 6/6 Suture and Sterile Polypropylene Suture comply with the requirements of the 3rd edition of the European Pharmacopoeia for Sterile Synthetic Non-absorbable Sutures [0324]. These requirements are reproduced after the heading Definitionbelow.

NOTE: The name Nylon 6 as a synonym for Polyamide 6 and Nylon 6/6 as a synonym for Polyamide 6/6 may be used freely in many countries, including the United Kingdom, but exclusive proprietary rights in this name are claimed in certain other countries.

Ph Eur ___________________________________________________________________________________________________________

DEFINITION

Sterile non-absorbable sutures are sutures which, when introduced into a living organism, are not metabolised by that organism. Sterile non-absorbable sutures vary in origin, which may be animal, vegetable, metallic or synthetic. They occur as cylindrical monofilaments or as multifilament sutures consisting of elementary fibres which are assembled by twisting, cabling or braiding; they may be sheathed; they may be treated to render them non-capillary, and they may be coloured. Appropriate harmonised standards may be considered when assessing compliance with respect to origin and processing of raw materials and with respect to biocompatibility. Sterile non-absorbable surgical sutures serve to approximate tissue during the healing period and provide continuing wound support.

Commonly used materials include the following:

Silk (Filum Bombycis)

Sterile braided silk suture is obtained by braiding a number of threads, according to the diameter required, of degummed silk obtained from the cocoons of the silkworm Bombyx mori L.

Linen (Filum Lini)

Sterile linen thread consists of the pericyclic fibres of the stem of Linum usitatissimum L. The elementary fibres, 2.5 cm to 5 cm long, are assembled in bundles 30 cm to 80 cm long and spun into continuous lengths of suitable diameter.

Poly(ethylene Terephthalate) (Filum Ethyleni Polyterephthalici)

Sterile poly(ethylene terephthalate) suture is obtained by drawing poly(ethylene terephthalate) through a suitable die. The suture is prepared by braiding very fine filaments in suitable numbers, depending on the gauge required.

Polyamide 6 (Filum Polyamidicum-6)

Sterile polyamide 6 suture is obtained by drawing through a suitable die a synthetic plastic material formed by the polymerisation of e-caprolactam. It consists of smooth, cylindrical monofilaments or braided filaments, or lightly twisted sutures sheathed with the same material.

Polyamide 6/6 (Filum polyamidicum 6/6)

Sterile polyamide 6/6 suture is obtained by drawing through a suitable die a synthetic plastic material formed by the polycondensation of hexamethylenediamine and adipic acid. It consists of smooth, cylindrical monofilaments or braided filaments, or lightly twisted sutures sheathed with the same material.

Polypropylene (Filum polypropylenicum)

Polypropylene suture is obtained by drawing polypropylene through a suitable die. It consists of smooth cylindrical monofilaments.

IDENTIFICATION

Non-absorbable sutures may be identified by chemical tests. Materials from natural origin may also be identified by microscopic examination of the morphology of these fibres. For synthetic materials, identification by infrared spectrophotometry (2.2.24) or by differential scanning calorimetry may be applied.

Identification of silk

  • A. Dissect the end of a suture, using a needle or fine tweezers, to isolate a few individual fibres. The

fibres are sometimes marked with very fine longitudinal striations parallel to the axis of the suture. Examined under a microscope, a cross-section is more or less triangular to semi-circular, with

rounded edges and without a lumen.

  • B. Impregnate isolated fibres with iodinated potassium iodide solution R. The fibres are coloured pale

yellow.

71-17

Identification of linen

  • A. Dissect the end of a suture, using a needle or fine tweezers, to isolate a few individual fibres.

Examined under a microscope, the fibres are seen to be 12 µm to 31 µm wide and, along the greater

part of their length, have thick walls, sometimes marked with fine longitudinal striations, and a narrow lumen. The fibres gradually narrow to a long, fine point. Sometimes there are unilateral swellings with transverse lines.

  • B. Impregnate isolated fibres with iodinated zinc chloride solution R. The fibres are coloured violet-

blue.

Identification of poly(ethyleneterephthalate)

It is practically insoluble in most of the usual organic solvents, but is attacked by strong alkaline solutions. It is incompatible with phenols.

  • A. It dissolves with difficulty when heated in dimethylformamide R and in dichlorobenzene R.

  • B. To about 50 mg add 10 ml of hydrochloric acid R1. The material remains intact even after

immersion for 6 h.

Identification of polyamide 6

It is practically insoluble in the usual organic solvents; it is not attacked by dilute alkaline solutions (for example a 100 g/l solution of sodium hydroxide R) but is attacked by dilute mineral acids (for example a 20 g/l solution of sulphuric acid R), by hot glacial acetic acid R and by a 70 per cent m/m solution of anhydrous formic acid R.

  • A. Heat about 50 mg with 0.5 ml of hydrochloric acid R1 in a sealed glass tube at 110°C for 18 h and

allow to stand for 6 h. No crystals appear.

  • B. It dissolves in a 70 per cent m/m solution of anhydrous formic acid R.

Identification of polyamide 6/6

It is practically insoluble in the usual organic solvents; it is not attacked by dilute alkaline solutions (for example a 100 g/l solution of sodium hydroxide R) but is attacked by dilute mineral acids (for example a 20 g/l solution of sulphuric acid R), by hot glacial acetic acid R and by an 80 per cent m/m solution of anhydrous formic acid R.

  • A. In contact with a flame it melts and burns, forming a hard globule of residue and gives off a

characteristic odour resembling that of celery.

  • B. Place about 50 mg in an ignition tube held vertically and heat gently until thick fumes are evolved.

When the fumes fill the tube, withdraw it from the flame and insert a strip of nitrobenzaldehyde

paper R. A violet-brown colour slowly appears on the paper and fades slowly in air; it disappears almost immediately on washing with dilute sulphuric acid R.

  • C. To about 50 mg add 10 ml of hydrochloric acid R1. The material disintegrates in the cold and

dissolves within a few minutes.

  • D. It does not dissolve in a 70 per cent m/m solution of anhydrous formic acid R but dissolves in an

80 per cent m/m solution of anhydrous formic acid R.

Identification of polypropylene

Polypropylene is soluble in decahydronaphthalene, 1-chloronaphthalene and trichloroethylene. It is not soluble in alcohol, ether and cyclohexanone.

  • A. It softens at temperatures between 160°C and 170°C. It burns with a blue flame giving off an

odour of burning paraffin wax and of octyl alcohol.

  • B. To 0.25 g add 10 ml of toluene R and boil under a reflux condenser for about 15 min. Place a few

drops of the solution on a disc of sodium chloride R slide and evaporate the solvent in an oven at 80°C. Examine by infrared absorption spectrophotometry (2.2.24), comparing with the spectrum obtained with polypropylene CRS.

  • C. To 2 g add 100 ml of water R and boil under a reflux condenser for 2 h. Allow to cool. The

relative density (2.2.5) of the material is 0.89 g/ml to 0.91 g/ml, determined using a hydrostatic balance.

PRODUCTION

The appropriate harmonised standards may apply with respect to appropriate validated methods of sterilisation, environmental control during manufacturing, labelling and packaging. It is essential for the effectiveness and the performance characteristics during use and during the functional lifetime of these sutures that the following physical properties are specified: consistent diameter, sufficient initial strength and firm needle attachment. The requirements below have been established, taking into account stresses which occur during normal conditions of use. These requirements can be used to demonstrate that individual production batches of these sutures are suitable for wound closure in accordance with usual surgical techniques.

71-18

TESTS

Remove the sutures from the sachet and measure promptly and in succession the length, diameter and mini- mum load.

If linen is tested the sutures are conditioned as follows: if stored in the dry state, expose to an atmos- phere with a relative humidity of 65 ± 5 per cent at 20 ± 2°C for 4 h immediately before measuring the diameter and for the determination of minimum breaking load immerse in water R at room temperature for 30 min immediately before carrying out the test.

Length Measure the length in the condition in which the sutures are presented and without applying more tension than is necessary to keep them straight. The length of the suture is not less than 95 per cent of the length stated on the label and does not exceed 400 cm.

Diameter Unless otherwise prescribed, measure the diameter by the following method using five sutures in the condition in which they are presented. Use a suitable mechanical instrument capable of measuring with an accuracy of at least 0.002 mm and having a circular pressor foot 10 mm to 15 mm in diameter. The pressor foot and the moving parts attached to it are weighted so as to apply a total load of 100 ± 10 g to the suture being tested. When making the measurements, lower the pressor foot slowly to avoid crushing the suture. Measure the diameter at intervals of 30 cm over the whole length of the suture. For a suture less than 90 cm in length, measure at three points approximately evenly spaced along the suture. During the measurement submit monofilament sutures to a tension not greater than that required to keep them straight. Submit multifilament sutures to a tension not greater than one-fifth of the minimum breaking load shown in column C of Table 324-1 appropriate to the gauge number and type of material concerned or 10 N whichever is the less. For multifilament sutures of gauge number above 1.5 make two measurements at each point, the second measurement being made after rotating the suture through 90°. The diameter of that point is the average of the two measurements. The average of the measurements carried out on the sutures being tested and not less than two-thirds of the measurements taken on each suture are within the limits given in the column under A in Table 3241 for the gauge number concerned. None of the measurements is outside the limits given in the columns under B in Table 3241 for the gauge number concerned.

Table 3241 Diameters and Minimum Breaking Loads

 

Diameter (millimetres)

 

Minimum breaking load (newtons)

Gauge

A

B

Linen thread

All other non

number

absorbable strands

 

min

max

min

max

C

D

C

D

0.05

0.005

0.009

0.003

0.012

0.01

0.1

0.010

0.019

0.005

0.025

0.03

0.15

0.015

0.019

0.012

0.025

0.06

0.01

  • 0.2 0.020

 

0.029

0.015

0.035

0.1

  • 0.3 0.030

0.039

0.025

0.045

0.35

0.06

  • 0.4 0.040

0.049

0.035

0.060

0.60

0.15

  • 0.5 0.050

0.069

0.045

0.085

1.0

0.35

  • 0.7 0.070

0.099

0.060

0.125

1.0

0.3

1.5

0.60

1

0.100

0.149

0.085

0.175

2.5

0.6

3.0

1.0

1.5

0.150

0.199

0.125

0.225

5.0

1.0

5.0

1.5

2

0.200

0.249

0.175

0.275

8.0

2.5

9.0

3.0

2.5

0.250

0.299

0.225

0.325

9.0

5.0

13.0

5.0

3

0.300

0.349

0.275

0.375

11.0

8.0

15.0

9.0

3.5

0.350

0.399

0.325

0.450

15.0

9.0

22.0

13.0

  • 4 0.400

 

0.499

0.375

0.550

18.0

11.0

27.0

15.0

  • 5 0.500

0.599

0.450

0.650

26.0

15.0

35.0

22.0

  • 6 0.600

0.699

0.550

0.750

37.0

18.0

50.0

27.0

  • 7 0.700

0.799

0.650

0.850

50.0

26.0

62.0

35.0

  • 8 0.800

0.899

0.750

0.950

65.0

37.0

73.0

50.0

Minimum breaking load Unless otherwise prescribed, determine the minimum breaking load by the following method using sutures in the condition in which they are presented. The minimum breaking load is determined over a simple knot formed by placing one end of a suture held in the right hand over the other end held in the left hand, passing one end over the suture and through the loop so formed (see Figure 3241) and pulling the knot tight.

71-19

71-19 Fig. 324–1 Simple knot Carry out the test on five sutures. Submit sutures of length

Fig. 324–1 Simple knot

Carry out the test on five sutures. Submit sutures of length greater than 75 cm to two measurements and shorter sutures to one measurement. Determine the breaking load using a suitable tensilometer. The apparatus has two clamps for holding the suture, one of which is mobile and is driven at a constant rate of 30 cm per minute. The clamps are designed so that the suture being tested can be attached without any possibility of slipping. At the beginning of the test the length of suture between the clamps is 12.5 cm to 20 cm and the knot is midway between the clamps. Set the mobile clamp in motion and note the force required to break the suture. If the suture breaks in a clamp or within 1 cm of it, the result is discarded and the test repeated on another suture. The average of all the results, excluding those legitimately discarded, is equal to or greater than the value given in column C in Table 3241 and no value is less than that given in column D for the gauge number and type of material concerned.

Table 3242 Minimum Strengths of Needle Attachment

Gauge

Mean value

Individual value

number

(newtons)

(newtons)

  • 0.4 0.25

0.50

  • 0.5 0.40

0.80

  • 0.7 0.80

1.7

1

2.3

1.1

1.5

4.5

2.3

2

6.8

3.4

2.5

9.0

4.5

3

11.0

4.5

3.5

15.0

4.5

  • 4 6.0

18.0

  • 5 7.0

18.0

Needle attachment If the sutures are supplied with an eyeless needle attached that is not stated to be detachable, they comply with the test for needle attachment. Carry out the test on five sutures. Use a suitable tensilometer, such as that described for the determination of the minimum breaking load. Fix the needle and suture (without knot) in the clamps of the apparatus in such a way that the swaged part of the needle is completely free of the clamp and in line with the direction of pull on the suture. Set the mobile clamp in motion and note the force required to break the suture or to detach it from the needle. The average of the five determinations and all individual values are not less than the respective values given in Table 3242 for the gauge number concerned. If not more than one individual value fails to meet the individual requirement, repeat the test on an additional ten sutures. The attachment complies with the test if none of these ten values is less than the individual value in Table 3242 for the gauge number concerned.

Extractable colour Sutures that are dyed and intended to remain so during use comply with the test for extractable colour. Place 0.25 g of the suture to be examined in a conical flask, add 25.0 ml of water R and cover the mouth of the flask with a short-stemmed funnel. Boil for 15 min, cool and adjust to the original volume with water R.

Depending on the colour of the suture, prepare the appropriate reference solution as described in Table 3243 using the primary colour solutions (2.2.2). The test solution is not more intensely coloured than the appropriate reference solution.

71-20

Table 3243 Colour Reference Solutions

Colour of

Composition of reference solution

 

strand

(parts by volume)

Red

Yellow

Blue

Water

primary

primary

primary

solution

solution

solution

Yellow

0.2

1.2

8.6

brown

Pinkred

1.0

9.0

Greenblue

2.0

8.0

Violet

1.6

8.4

Monomer and oligomers Polyamide 6 suture additionally complies with the following test for monomer and oligomers. In a continuous-extraction apparatus, treat 1.00 g with 30 ml of methanol R at a rate of at least three extractions per hour for 7 h. Evaporate the extract to dryness, dry the residue at 110°C for 10 min, allow to cool in a desiccator and weigh. The residue weighs not more than 20 mg (2 per cent).

STORAGE (PACKAGING)

Sterile non-absorbable sutures are presented in a suitable sachet that maintains sterility and allows the withdrawal and use of a suture in aseptic conditions. They may be stored dry or in a preserving liquid to which an antimicrobial agent but no antibiotic may be added. Sterile non-absorbable sutures are intended to be used only on the occasion when the sachet is first opened. Sutures in their individual sachets (primary packaging) are kept in a protective cover (box) which maintains the physical and mechanical properties until the time of use. The application of appropriate harmonised standards for packaging of medical devices shall be considered in addition.

LABELLING

Reference may be made to the appropriate harmonised standards for the labelling of medical devices. The details strictly necessary for the user to identify the product properly are indicated on or in each sachet (primary packaging) and on the protective cover (box) and include at least:

gauge number, length in centimetres or metres, if appropriate, that the needle is detachable, name of the product, intended use (surgical suture, non-absorbable), if appropriate, that the suture is coloured, if appropriate, the structure (braided, monofilament, sheathed).

Ph Eur

__________________________________________________________________________________________________________

Infrared Reference Spectra

S2

Infrared Reference Spectra

Preparation of Infrared Reference Spectra

All spectra presented in this section were recorded using either a Perkin-Elmer model 682 dispersive infrared spectrophotometer or a Perkin Elmer model 16PC Fourier transform infrared spectrophotometer. Pressed discs, 13 mm in diameter, were prepared using potassium bromide or potassium chloride. Liquid paraffin mulls and thin films were prepared between potassium bromide plates, and gas and solution spectra were prepared using cells with potassium bromide windows. Solution spectra were prepared against a solvent reference and all other spectra were recorded against air. For solution spectra the regions of the spectrum within which the solvent shows strong absorption should be disregarded. Solvent cut-offsin the reference spectra may be recorded as horizontal straight lines or may appear as blank regions on the spectrum.

Polystyrene Instrument: Dispersive Instrument: Dispersive Phase: Thin film Thickness 0.038mm Phase: Potassium bromide disc 100 80
Polystyrene
Instrument: Dispersive
Instrument: Dispersive
Phase: Thin film
Thickness 0.038mm
Phase: Potassium bromide disc
100
80
60
40
20
0
0
2000 4000 1800 3600 1600 3200 1400 2800 1200 2400 2000 1000 800 600 400 Instrument:
2000
4000
1800
3600
1600
3200
1400
2800
1200
2400
2000
1000
800
600
400
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance
Transmittance

Transmittance

Transmittance

100

80

60

40

20

0

100

80

60

40

20

0

100

80

60

40

20

0

Polystyrene Instrument: Fourier transform Instrument: Phase: Thin Dispersive film Thickness 0.038mm Phase: Potassium bromide disc
Polystyrene
Instrument: Fourier transform
Instrument: Phase: Thin Dispersive film
Thickness 0.038mm
Phase: Potassium bromide disc
4000 3600 3200 2800 2400 2000 2000 1800 1600 1400 1200 1000 800 600 Instrument: Dispersive
4000
3600
3200
2800
2400
2000
2000
1800
1600
1400
1200
1000
800
600
Instrument: Dispersive
Phase: Potassium bromide disc
2000
1800 1600
1400
1200
1000
800
600
Wavenumber (cm -1 )
Instrument: Dispersive
Phase: Potassium bromide disc
2000
1800 1600
1400
1200
1000
800
600
Wavenumber (cm -1 )

400

400

400

RS 001: Acenocoumarol

Instrument: Dispersive

Phase: Potassium bromide disc

100 (Nicoumalone) 80 60 40 20 0
100
(Nicoumalone)
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 002: Acetazolamide Instrument: Dispersive Phase: Potassium
2000
1800
1600
1400
1200
1000
800
600
400
RS 002: Acetazolamide
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance
Transmittance
RS 003: Acetyl- Instrument: Dispersive Instrument: Phase: Dispersive Potassium bromide disc Phase: Potassium bromide disc 100
RS 003: Acetyl-
Instrument: Dispersive
Instrument: Phase: Dispersive Potassium bromide disc
Phase: Potassium bromide disc
100
cysteine
80
60
40
20
0
4000
3600
3200
2800
2400
2000
2000
1800
1600
1400
1200
1000
800
600
400

Instrument: Dispersive

Phase: Potassium bromide disc

100 80 60 40 20 0
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 004: Adrenaline (Epinephrine) Instrument: Dispersive Dispersive
2000
1800 1600
1400
1200
1000
800
600
400
RS 004: Adrenaline (Epinephrine)
Instrument: Dispersive
Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800 1600
1400
1200
1000
800
600
400
Transmittance

Wavenumber (cm -1 )

RS 005: Alimemazine Instrument: Dispersive Instrument: Dispersive Phase: 10% w/v solution in chloroform Phase: Potassium bromide
RS 005: Alimemazine
Instrument: Dispersive
Instrument: Dispersive
Phase: 10% w/v solution in chloroform
Phase: Potassium bromide disc
Thicknesss: 0.1mm
100
(Trimeprazine)
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 006: Amantadine Instrument: Dispersive Phase: Potassium
2000
1800
1600
1400
1200
1000
800
600
400
RS 006: Amantadine
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 007: Aminobenzoic Acid
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance

Transmittance

100

80

60

40

20

0

100

80

60

40

20

0

100

80

60

40

20

0

RS 008: Amiodarone

Instrument: Instrument: Dispersive Dispersive

Phase: 15% w/v solution in dichloromethane

Phase: Potassium bromide disc

Thickness: 0.1mm

Transmittance 100 80 60 40 20 0 100 80 60 40 20 0 100 80 60
2000 1800 1600 1400 1200 1000 800 600 RS 009: Ammonium Glycyrrhizinate Instrument: Fourier Dispersive Transform
2000
1800
1600
1400
1200
1000
800
600
RS 009: Ammonium
Glycyrrhizinate
Instrument: Fourier Dispersive Transform
Phase: Potassium bromide disc
2000
1800
1600
1400
1200
1000
800
600
RS 010: Amoxicillin Sodium
Instrument: Dispersive
Phase: Potassium bromide disc
2000
1800
1600
1400
1200
1000
800
600
Wavenumber (cm -1 )

400

400

400

RS 011: Amoxicillin Trihydrate

Instrument: Dispersive

Phase: Potassium bromide disc

100 80 60 40 20 0
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 012: Amphotericin Instrument: Dispersive Phase: Potassium
2000
1800
1600
1400
1200
1000
800
600
400
RS 012: Amphotericin
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 013: Ampicillin Trihydrate
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance
RS 014: Amylmetacresol Instrument: Dispersive Phase: Potassium bromide disc Phase: Thin Film 100 80 60 40
RS 014: Amylmetacresol
Instrument: Dispersive
Phase: Potassium bromide disc
Phase: Thin Film
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 015: Atenolol Instrument: Dispersive Phase: Potassium
2000
1800
1600
1400
1200
1000
800
600
400
RS 015: Atenolol
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 016: Azapropazone
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance

RS 017: Anhydrous Azapropazone

Instrument: Dispersive

Phase: Potassium bromide disc

100 80 60 40 20 0
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 018: Azelastine Hydrochloride Instrument: Dispersive Fourier
2000
1800
1600
1400
1200
1000
800
600
400
RS 018: Azelastine Hydrochloride
Instrument: Dispersive
Fourier transform
Phase: Potassium bromide chloride disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 019: Azlocillin Sodium
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance
RS 020: Beclometasone Instrument: Dispersive Phase: 5% w/v solution in chloroform Phase: Potassium bromide disc Thickness:
RS 020: Beclometasone
Instrument: Dispersive
Phase: 5% w/v solution in chloroform
Phase: Potassium bromide disc
Thickness: 0.1mm
100
Dipropionate (1)
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 021: Beclometasone Dipropionate Instrument: Dispersive Instrument:
2000
1800
1600
1400
1200
1000
800
600
400
RS 021: Beclometasone Dipropionate
Instrument: Dispersive Instrument: Fourier transform
Phase: Potassium bromide disc
100
Monohydrate
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 022: Benethamine Penicillin
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance

RS 023: Benorilate

Instrument: Dispersive

Phase: Potassium bromide disc

100 80 60 40 20 0
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 100 RS 024: Benzhexol Hydrochloride (Trihexyphenidyl Hydrochloride)
2000
1800
1600
1400
1200
1000
800
600
400
100
RS 024: Benzhexol Hydrochloride
(Trihexyphenidyl
Hydrochloride)
Instrument: Dispersive
Phase: Potassium bromide chloride disc
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 025: Benzoic Acid
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance

RS 026: Benzatropine Mesilate

Instrument: Dispersive

Phase: Potassium bromide disc

Phase: Liquid paraffin mull

100 80 60 40 20 0
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 027: Benzydamine Instrument: Fourier Dispersive transform
2000
1800
1600
1400
1200
1000
800
600
400
RS 027: Benzydamine
Instrument: Fourier Dispersive transform
Phase: Potassium bromide disc
chloride
100
Hydrochloride
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 028: Benzyl Hydroxybenzoate
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance

RS 029: Betamethasone

Instrument: Dispersive

Phase: Potassium bromide disc

100 80 60 40 20 0
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 030: Bretylium Tosilate Instrument: Dispersive Fourier
2000
1800
1600
1400
1200
1000
800
600
400
RS 030: Bretylium Tosilate
Instrument: Dispersive
Fourier transform
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 031: Bronopol
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance
RS 032: Buclizine Hydrochloride Instrument: Dispersive Phase: Potassium bromide disc chloride 100 80 60 40 20
RS 032: Buclizine Hydrochloride
Instrument: Dispersive
Phase: Potassium bromide disc
chloride
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 032: Bumetanide Instrument: Dispersive Phase: Potassium
2000
1800
1600
1400
1200
1000
800
600
400
RS 032: Bumetanide
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 034: Bupivacaine
Instrument: Dispersive
Phase: Potassium bromide disc
Phase: Liquid paraffin mull
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance
RS 035: Busulfan Instrument: Dispersive Phase: Potassium bromide disc 100 80 60 40 20 0
RS 035: Busulfan
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 036: Butyl Hydroxybenzoate Instrument: Dispersive Phase:
2000
1800
1600
1400
1200
1000
800
600
400
RS 036: Butyl Hydroxybenzoate
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 037: Calcium Polystyrene
Instrument: Fourier transform
Dispersive
Phase: Potassium bromide disc
100
Sulphonate
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance
RS 038: Captopril Instrument: Dispersive Phase: Potassium bromide disc 100 80 60 40 20 0
RS 038: Captopril
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 039: Carbaryl Instrument: Dispersive Phase: Potassium
2000
1800
1600
1400
1200
1000
800
600
400
RS 039: Carbaryl
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 040: Carbenicillin Sodium
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance

100

80

60

40

20

0

RS 041: Carbenoxolone

Instrument: Dispersive

Phase: Potassium bromide disc

100 80 60 40 20 0 RS 041: Carbenoxolone Instrument: Dispersive Phase: Potassium bromide disc 2000
2000 1800 1600 1400 1200 1000 800 600 400 RS 042: Carbimazole Instrument: Dispersive Phase: Potassium
2000
1800
1600
1400
1200
1000
800
600
400
RS 042: Carbimazole
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 043: Carteolol Hydrochloride
Instrument: Fourier Dispersive transform
Phase: Potassium bromide disc
chloride
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance

100

80

60

40

20

0

RS 044: Cefotaxime Sodium

Instrument: Dispersive

Phase: Potassium bromide disc

100 80 60 40 20 0 RS 044: Cefotaxime Sodium Instrument: Dispersive Phase: Potassium bromide disc
2000 1800 1600 1400 1200 1000 800 600 400 RS 045: Cefoxitin Sodium Instrument: Fourier Dispersive
2000
1800
1600
1400
1200
1000
800
600
400
RS 045: Cefoxitin Sodium
Instrument: Fourier Dispersive transform
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 046: Ceftriaxone Sodium
Instrument: Fourier Dispersive transform
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance

RS 047: Cefuroxime Axetil

Instrument: Dispersive

Phase: Potassium bromide disc

100 80 60 40 20 0
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 048: Cefuroxime Sodium Instrument: Fourier transform
2000
1800
1600
1400
1200
1000
800
600
400
RS 048: Cefuroxime Sodium
Instrument: Fourier transform
Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 049: Cefalexin
Instrument: Fourier Dispersive transform
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance
RS 050: Cefradine Instrument: Dispersive Phase: Potassium bromide disc 100 80 60 40 20 0
RS 050: Cefradine
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 051: Clomethiazole Instrument: Dispersive Phase: Potassium
2000
1800
1600
1400
1200
1000
800
600
400
RS 051: Clomethiazole
Instrument: Dispersive
Phase: Potassium bromide disc
Phase: Thin
100
film
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 052: Clomethiazole Edisilate
Instrument: Dispersive
Phase: Potassium bromide disc
Phase: Liquid paraffin mull
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance
RS 053: Chloroform Instrument: Dispersive Phase: Potassium bromide disc Phase: 0.1mm Layer 100 80 60 40
RS 053: Chloroform
Instrument: Dispersive
Phase: Potassium bromide disc
Phase: 0.1mm Layer
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 054: Chloroquine Instrument: Dispersive Phase: 5%
2000
1800
1600
1400
1200
1000
800
600
400
RS 054: Chloroquine
Instrument: Dispersive
Phase: 5% w/v solution in chloroform
Phase: Potassium bromide disc
Thickness: 0.1mm
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 055: Chloroxylenol
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance
RS 056: Chlorpromazine Instrument: Dispersive Phase: 5% w/v solution in chloroform Phase: Potassium bromide disc Thickness:
RS 056: Chlorpromazine
Instrument: Dispersive
Phase: 5% w/v solution in chloroform
Phase: Potassium bromide disc
Thickness: 0.1mm
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 057: Chlorpropamide Instrument: Dispersive Phase: Potassium
2000
1800
1600
1400
1200
1000
800
600
400
RS 057: Chlorpropamide
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 058: Chlortalidone
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance
RS 059: Choline Salicylate Instrument: Dispersive Phase: Potassium bromide disc Phase: Thin film 100 80 60
RS 059: Choline Salicylate
Instrument: Dispersive
Phase: Potassium bromide disc
Phase: Thin film
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 060: Choline Theophyllinate Instrument: Dispersive Phase:
2000
1800
1600
1400
1200
1000
800
600
400
RS 060: Choline Theophyllinate
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 061: Cimetidine
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance

RS 062: Cinnamic Acid

Instrument: Dispersive

Phase: Potassium bromide disc

100 80 60 40 20 0
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 063: Clemastine Fumarate Instrument: Dispersive Phase:
2000
1800
1600
1400
1200
1000
800
600
400
RS 063: Clemastine Fumarate
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 064: Clindamycin
Instrument: Dispersive
Phase: Potassium bromide disc
chloride
100
Hydrochloride
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance

RS 065: Clioquinol

Instrument: Dispersive

Phase: Potassium bromide disc

100 80 60 40 20 0
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 066: Clobazam Instrument: Dispersive Phase: Potassium
2000
1800
1600
1400
1200
1000
800
600
400
RS 066: Clobazam
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 067: Clobetasol Propionate
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance

RS 068: Clofazimine

Instrument: Dispersive

Phase: Potassium bromide disc

Phase: Liquid Paraffin mull

100 80 60 40 20 0
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 069: Clomipramine Instrument: Dispersive Phase: Phase:
2000
1800
1600
1400
1200
1000
800
600
400
RS 069: Clomipramine
Instrument: Dispersive
Phase: Phase: Potassium Potassium bromide chloride disc disc
100
Hydrochloride
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 070: Cloxacillin Sodium
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )
Transmittance
RS 071: Cocaine Instrument: Fourier transform Dispersive Phase: Potassium bromide disc 100 80 60 40 20
RS 071: Cocaine
Instrument: Fourier transform
Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000 1800 1600 1400 1200 1000 800 600 400 RS 072: Codeine Instrument: Dispersive Phase: Potassium
2000
1800
1600
1400
1200
1000
800
600
400
RS 072: Codeine
Instrument: Dispersive
Phase: Potassium bromide disc
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
RS 073: Codeine Hydrochloride
Instrument: Dispersive
Phase: Phase: Potassium Liquid bromide Paraffin disc mull
100
80
60
40
20
0
2000
1800
1600
1400
1200
1000
800
600
400
Wavenumber (cm -1 )