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Olive oil, virgin EUROPEAN PHARMACOPOEIA 5.

When cooled, it begins to become cloudy at 10 C and oleic acid (equivalent chain length on polyethyleneglycol
becomes a butter-like mass at about 0 C. It has a relative adipate 18.3) : 56.0 per cent to 85.0 per cent,
density of about 0.913. linoleic acid (equivalent chain length on
polyethyleneglycol adipate 18.9) : 3.5 per cent to
IDENTIFICATION
20.0 per cent,
A. It complies with the test for absorbance (see Tests).
linolenic acid (equivalent chain length on
B. Carry out the test for identification of fatty oils by polyethyleneglycol adipate 19.7) : not more than 1.2 per
thin-layer chromatography (2.3.2). The chromatogram cent,
obtained shows spots corresponding to those in the
arachidic acid : not more than 0.7 per cent,
typical chromatogram for olive oil. For certain types of
refined olive oil, the difference in the size of spots E and eicosenoic acid (equivalent chain length on
F is less pronounced than in the typical chromatogram. polyethyleneglycol adipate 20.3) : not more than 0.4 per
cent,
TESTS behenic acid : not more than 0.2 per cent,
Acid value (2.5.1). Not more than 0.5, determined on 10.0 g. lignoceric acid : not more than 0.2 per cent.
Peroxide value (2.5.5, Method A). Not more than 10.0. If Sterols (2.4.23). The sterol fraction of the oil has the
intended for use in the manufacture of parenteral dosage following composition :
forms, not more than 5.0. sum of contents of -sitosterol, 5,23-stigmastadienol,
Unsaponifiable matter. Not more than 1.5 per cent. Place clerosterol, sitostanol, 5-avenasterol and
5.0 g (m g) in a 150 ml flask fitted with a reflux condenser. 5,24-stigmastadienol: not less than 93.0 per cent,
Add 50 ml of 2 M alcoholic potassium hydroxide R and heat cholesterol : not more than 0.5 per cent,
on a water-bath for 1 h, shaking frequently. Add 50 ml of 7-stigmasterol : not more than 0.5 per cent,
water R through the top of the condenser, shake, allow to
cool and transfer the contents of the flask to a separating campesterol : not more than 4.0 per cent,
funnel. Rinse the flask with several portions to a total and the content of stigmasterol is not more than that of
of 50 ml of light petroleum R1 and add the rinsings to campesterol.
the separating funnel. Shake vigorously for 1 min. Allow Sesame oil. In a ground-glass-stoppered cylinder shake
to separate and transfer the aqueous layer to a second 10 ml for about 1 min with a mixture of 0.5 ml of a 0.35 per
separating funnel. If an emulsion forms, add small quantities cent V/V solution of furfural R in acetic anhydride R and
of alcohol R or a concentrated solution of potassium 4.5 ml of acetic anhydride R. Filter through a filter paper
hydroxide R. Shake the aqueous layer with 2 quantities, impregnated with acetic anhydride R. To the filtrate add
each of 50 ml, of light petroleum R1. Combine the light 0.2 ml of sulphuric acid R. No bluish-green colour develops.
petroleum layers in a third separating funnel and wash with
3 quantities, each of 50 ml, of alcohol (50 per cent V/V) R. Water (2.5.32). If intended for use in the manufacture
Transfer the light petroleum layer to a tared 250 ml flask. of parenteral dosage forms, not more than 0.1 per cent,
Rinse the separating funnel with small quantities of light determined on 5.0 g by the coulometric method. Use a
petroleum R1 and add to the flask. Evaporate the light mixture of equal volumes of decanol R and anhydrous
petroleum on a water-bath and dry the residue at 100 C methanol R as solvent.
to 105 C for 15 min, keeping the flask horizontal. Allow STORAGE
to cool in a desiccator and weigh (a g). Repeat the drying
for successive periods of 15 min until the loss of mass Store in a well-filled container, protected from light, at a
between 2 successive weighings does not exceed 0.1 per temperature not exceeding 25 C. If intended for use in
cent. Dissolve the residue in 20 ml of alcohol R, previously the manufacture of parenteral dosage forms, store under
neutralised to 0.1 ml of bromophenol blue solution R. If an inert gas.
necessary, titrate with 0.1 M hydrochloric acid (b ml). LABELLING
Calculate the percentage content of unsaponifiable matter The label states :
from the expression :
where applicable, that the substance is suitable for use in
the manufacture of parenteral dosage forms,
the name and concentration of any added antioxidant,
If 0.032b is greater than 5 per cent of a, the test is invalid the name of the inert gas.
and must be repeated.
Alkaline impurities (2.4.19). It complies with the test for 01/2005:0518
alkaline impurities in fatty oils.
Absorbance (2.2.25). Dissolve 1.00 g in cyclohexane R and OLIVE OIL, VIRGIN
dilute to 100.0 ml with the same solvent. The absorbance
measured at 270 nm is 0.20 to 1.20. Olivae oleum virginale
Composition of fatty acids (2.4.22, Method A). The fatty acid
fraction of the oil has the following composition : DEFINITION
saturated fatty acids of chain length less than C16 : not Virgin olive oil is the fatty oil obtained by cold expression or
more than 0.1 per cent, other suitable mechanical means from the ripe drupes of
palmitic acid : 7.5 per cent to 20.0 per cent, Olea europaea L.
palmitoleic acid (equivalent chain length on CHARACTERS
polyethyleneglycol adipate 16.3) : not more than 3.5 per A clear, yellow or greenish-yellow, transparent liquid with a
cent, characteristic odour, practically insoluble in alcohol, miscible
stearic acid : 0.5 per cent to 5.0 per cent, with light petroleum (50 C to 70 C).

2136 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.0 Olsalazine sodium

When cooled, it begins to become cloudy at 10 C and linoleic acid (equivalent chain length on
becomes a butter-like mass at about 0 C. It has a relative polyethyleneglycol adipate 18.9) : 3.5 per cent to
density of about 0.913. 20.0 per cent,
linolenic acid (equivalent chain length on
IDENTIFICATION polyethyleneglycol adipate 19.7) : not more than 1.2 per
Carry out the test for identification of fatty oils by thin-layer cent,
chromatography (2.3.2). The chromatogram obtained shows arachidic acid : not more than 0.7 per cent,
spots corresponding to those in the typical chromatogram eicosenoic acid (equivalent chain length on
for olive oil. For certain types of olive oil, the difference in polyethyleneglycol adipate 20.3) : not more than 0.4 per
the size of spots E and F is less pronounced than in the cent,
typical chromatogram. behenic acid : not more than 0.2 per cent,
lignoceric acid : not more than 0.2 per cent.
TESTS
Sterols (2.4.23). The sterol fraction of the oil has the
Acid value (2.5.1). Not more than 2.0, determined on 5.0 g. following composition :
Peroxide value (2.5.5, Method A). Not more than 20.0. sum of contents of -sitosterol, 5,23-stigmastadienol,
Unsaponifiable matter. Not more than 1.5 per cent. Place clerosterol, sitostanol, 5-avenasterol and
5.0 g (m g) in a 150 ml flask fitted with a reflux condenser. 5,24-stigmastadienol: not less than 93.0 per cent,
Add 50 ml of 2 M alcoholic potassium hydroxide R and heat cholesterol : not more than 0.5 per cent,
on a water-bath for 1 h, shaking frequently. Add 50 ml of 7-stigmasterol : not more than 0.5 per cent,
water R through the top of the condenser, shake, allow to campesterol : not more than 4.0 per cent,
cool and transfer the contents of the flask to a separating
funnel. Rinse the flask with several portions to a total and the content of stigmasterol is not more than that of
of 50 ml of light petroleum R1 and add the rinsings to campesterol.
the separating funnel. Shake vigorously for 1 min. Allow Sesame oil. In a ground-glass-stoppered cylinder shake
to separate and transfer the aqueous layer to a second 10 ml for about 1 min with a mixture of 0.5 ml of a 0.35 per
separating funnel. If an emulsion forms, add small quantities cent V/V solution of furfural R in acetic anhydride R and
of alcohol R or a concentrated solution of potassium 4.5 ml of acetic anhydride R. Filter through a filter paper
hydroxide R. Shake the aqueous layer with 2 quantities, impregnated with acetic anhydride R. To the filtrate add
each of 50 ml, of light petroleum R1. Combine the light 0.2 ml of sulphuric acid R. No bluish-green colour develops.
petroleum layers in a third separating funnel and wash with
3 quantities, each of 50 ml, of alcohol (50 per cent V/V) R. STORAGE
Transfer the light petroleum layer to a tared 250 ml flask. Store in a well-filled container, protected from light, at a
Rinse the separating funnel with small quantities of light temperature not exceeding 25 C.
petroleum R1 and add to the flask. Evaporate the light
petroleum on a water-bath and dry the residue at 100 C 01/2005:1457
to 105 C for 15 min, keeping the flask horizontal. Allow
to cool in a desiccator and weigh (a g). Repeat the drying OLSALAZINE SODIUM
for successive periods of 15 min until the loss of mass
between 2 successive weighings does not exceed 0.1 per Olsalazinum natricum
cent. Dissolve the residue in 20 ml of alcohol R, previously
neutralised to 0.1 ml of bromophenol blue solution R. If
necessary, titrate with 0.1 M hydrochloric acid (b ml).
Calculate the percentage content of unsaponifiable matter
from the expression :

C14H8N2Na2O6 Mr 346.2
If 0.032b is greater than 5 per cent of a, the test is invalid DEFINITION
and must be repeated. Olsalazine sodium contains not less than 98.0 per cent and
Absorbance (2.2.25). Dissolve 1.00 g in cyclohexane R and not more than the equivalent of 102.0 per cent of disodium
dilute to 100.0 ml with the same solvent. The absorbance 3,3-diazenediylbis(6-hydroxybenzoate), calculated with
measured at 270 nm is not greater than 0.20. The ratio of the reference to the dried and acetate-free substance.
absorbance at 232 nm to that at 270 nm is greater than 8.
CHARACTERS
Composition of fatty acids (2.4.22, Method A). The fatty acid
fraction of the oil has the following composition : A yellow, fine, crystalline powder, sparingly soluble in water,
soluble in dimethyl sulphoxide, very slightly soluble in
saturated fatty acids of chain length less than C16 : not methanol.
more than 0.1 per cent, It shows polymorphism.
palmitic acid : 7.5 per cent to 20.0 per cent,
IDENTIFICATION
palmitoleic acid (equivalent chain length on First identification : B, D.
polyethyleneglycol adipate 16.3) : not more than 3.5 per
cent, Second identification : A, C, D.
A. Dissolve 40.0 mg in 5 ml of 0.1 M sodium hydroxide
stearic acid : 0.5 per cent to 5.0 per cent, and dilute to 100.0 ml with a 7.8 g/l solution of sodium
oleic acid (equivalent chain length on polyethyleneglycol dihydrogen phosphate R adjusted to pH 7.2 with strong
adipate 18.3) : 56.0 per cent to 85.0 per cent, sodium hydroxide solution R (buffer solution). Dilute

General Notices (1) apply to all monographs and other texts 2137