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s USP34

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Physical Test\ / (660) Containers-Glass

255

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substance. Pronounced su ercooling may cause deviation from the normal pattern f temperature changes. If the latter occurs, repeat the tes introducing small particles of the material under test in soli form at 10 intervals as the temperature approaches the xpected congealing point. Record the reading of he test tube thermometer every 30 seconds. Continue stirrin only so long as the temperature is gradually falling, stop ng when the temperature becomes constant or starts to rise slightly. Continue recording the temperature in the t st tube every 30 seconds for at least 3 minutes after the temperature again begins to fall after remaining constan The average of not Ie than four consecutive readings that lie within a range 0 0.2 constitutes the congealing temperature. These rea ngs lie about a point of inflection or a maximum, in the t mperature-time curve, that occurs after the temperature b comes constant or starts to rise and before it again begins t fall. The average to the nearest 0.1 is the congealing t mperature.

10lcml

+JWl+ '"
1.85 em

Filling. line

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15em
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CONTAINERS-GLASS

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3.75 em

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3.75 em

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3.75cm

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Temperature Apparatus The specimen conta er is supported, by means of a cork, in a suitable water-tig t cylinder about 50 mm in internal diameter and 11 cm i length. The cylinder, in turn, is suppor:ted in a suitable b h sufficient to provide not less than a 37::mm layer surround ng the sides and bottom of the cylinder.'The outside bath s provided with a suitable thermometer. 'Procedure-Melt t e substance, if a solid, at a temperature" not exceeding 2 above its expected congealing point, and pour it int the test tube to a height of 50 to ?7 mllJ. Assemble the apparatus with the burb of the test tube thermometer im ersed halfway between the top and bottom of the specim n in the test tube. Fill the bath to about 12 mm from t top of the tube with suitable fluid at a t~mperature 4 to below the expected congealing point. In case the substan e is a liquid at room temperature, carryol!t the determi ation using a bath temperature about 15 below the expec d congealing point. .When the test spec men has cooled to about 5 above its expected congealing oint, adjust the bath to a temperature 1 to 8 below t e expected congealing point. Stir the speCimen continuous during the remainder of the test by moving the loop up nd down between the top and bottom of the specimen at a regular rate of 20 complete cycles per minute. . Congelation frequ ntly may be induced by rubbing the ~nner walls of the te t tube with the thermometer, or by Introducing a small ragment of the previously congealed

Glass containers for pharmaceutical use are intended to come into direct contact with pharmaceutical preparations. Glass used for pharmaceutical containers is either a borosilicate (neutral) glass or a soda-lime glass. Borosilicate glass contains a significant amount of boric oxide, aluminum oxide, and alkali and/or alkaline earth oxides. Borosilicate glass has a high hydrolytic resistance due to the chemical composition of the glass itself; it is classified as Type I glass. Sodalime glass is a silica glass containing alkali metal oxides. Soda-lime glass has a moderate hydrolytic resistance due to the chemical composition of the glass itself; it is classified as Type III glass. The inner surface of glass containers may be treated, for example, to improve hydrolytic resistance. The treatment of Type III soda-lime glass containers will raise their hydrolytic resistance from a moderate to a high level, changing the classification of the glass to Type II. The outer surface of glass containers may be treated to reduce friction or for rotection against abrasion or breakage. The treatment 0 the outer surface does not come into contact with the inner surface of the container. Glass may be colored to provide protection from light or may have a coating applied to the outer surface. Such containers will meet the requirements for Light Transmission under Containers-Performance Testing (671). A clear and colorless or a translucent container that is made light-resistant by means of an opaque enclosure (see Light-Resistant Container in Preservation, Packaging, Storage, and Labeling under the General Notices) is exempt from the requirements for Light Transmission. The quality of glass containers is defined by measuring their resistance to chemical attack. In addition, Type I containers for aqueous parenteral preparations are tested for arsenic release, and colored glass containers are tested for light transmission.

CHEMICAL RESISTANCE
The following tests are designed to determine the resistance to water attack of new (not previously used) glass containers. The degree of attack is determined by the amount of alkali released from the glass under the influence of the attacking medium under the conditions specified. This quantity of alkali is extremely small in the case of the more resistant glasses, thus calling for particular attention to all details of the tests and the use of apparatus of high

256 (66O) Containers-Glass

/ Physical Tests

[0

T
USP 34 t

quality and precision. The tests should be conducted in an area relativelyfree from fumes and excessive dust. Glass Types-Glass containers suitable for packaging Pharmacopeial reparationsmay be classified in Table1 p as on the basis of the tests set forth in this section. Containers of Type I borosilicate glass are generally used for preparations that are intended for arenteral administration. Containers of Type I glass, or 0 Type II glass (i.e., soda-lime glass that is suitably dealkalized) are usually used for packaging acidic and neutral parenteral preparations. Type I glass containers, or Type II glass containers (where stability data demonstrate their suitability), are used for alkaline parenteral preparations. Type III soda-lime glass containers usually are not used for parenteral preparations, except where suitable stability test data indicate that Type IIIglass is satisfactory for the parenteral preparations that are packaged therein.

Table 1. Glass Types TVDe I II III General Descriotion TVDe of Test Highly resistant, borosilicate olass Treated soda-lime olass Soda-lime olass

furic acidso that the titration of 100 mL of High-Purity i Water,containing 5 drops of indicator, does not require
Powdered Glass
Water Attack Powdered Glass

this water is not contaminated by copper or its products (e.g., copper pipes, stills, or receivers). The water may be prepared by passing distilled water through a deionizer cartridge packed with a mixed bed of nuclear-grade resin, then through a cellulose ester membrane having openings not exceeding 0.45 !lm.2 Do not use copper tubing. Flush the discharge lines before water is dispensed into test vessels. When the low conductivity specification can no longer be met, replace the deionizer cartridge. Carbon Dioxide-Free Water-This is Purified Water that has been boiled vigorouslyfor 5 minutes or more and allowed to cool while protected from absorption of carbon dioxide from the atmosphere, or Purified Water that has a resistivity of not less than 18 Mohm-cm. Methyl Red Solution (Powdered Gloss Test and Water Attock at 12 JO )-Dissolve 24 mg of methyl red sodium in Purified Water to make 100 mL. If necessary, neutralize the solution with 0.02 N sodium hydroxide, or acidify it with 0.02 N sul-

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ApparatusAutoclave-For these tests, use an autoclave capable of maintaining a temperature of 121 :t 2.0, equipped with a thermometer, a pressure gauge, a vent cock, and a rack adequate to accommodate at least 12 test containers above the water level. Mortar and Pestle-Use a hardened-steel mortar arid pestle, made according to the specifications in Figure 1.

more than 0.020 mL of 0.020 N sodium hydroxide to effect the color change of the indicator, which shQuld occur at a pH of 5.6. MethylRed Solution(Surface Gloss Test)-Dissolve 50 mg of methyl red solution in 1.86 mL of 0.1 M sodium hydroxide and 50 mL of ethanol (96%) and dilute to 100 mL with Purified Water. To test for sensitivity, add 100 mL of Carbon Dioxide-Free aterand 0.05 mL of 0.02 M hydrochloric acid W to 0.1 mL of the methyl red solution (the solution should be red). Not more than 0.1 mL of 0.02 M sodium hydroxide is required to change the color to yellow. Color change: pH 4.4 (red) to pH 6.0 (yellow).

Powdered Glass Test


Rinsethoroughly with Purified Water sixor more containers selectedat random,and dry them with a current of
clean, dry air. Crush the containers into fragments about 25 mm in size, divide about 100 g of the coarsely crushed glass into three approximately equal portions, and place one of the portions in the special.mortar. With the pestle in place, crush the glass further.by striking 3 or 4 blows with the hammer. Nest the sieves, and empty the mortar into the No. 20 sieve. Repeat the operation on each of the two remaining portions of glass, emptying the mortar each time into the No. 20 sieve. Shake the sieves for a short time, then remove the glass from the Nos. 20 and 40 sieves, and again crush and sieve as before. Repeat again this crushing. and sieving operation. Empty the receiving pan, reassempfe: the nest of sieves, and shake by mechanical means for 5 minutesor by handfor an equiValent length of time. Trans" fer the portion retained on the No. 50 sieve, which should weigh in excess of 109, to a closed container, and store in a desiccator until used for the test. Spread the specimen on a pi~ce of glazed paper, and pass
a magnet

Figure 1. Mortar and Pestle for Pulverizing Glass' Other Equipi'nent-Also required are 20.3-cm (8-inch) sieves made of stainless steel, including the Nos. 20, 40, and 50 sieves, fllong with the pan and cover (see Sizes of Standard Sieve Series in Range of Interest under Particle Size DistributionEstimationby AnalyticalSieving(786); 250-mL conical flasks made of resistant glass aged as specified;a 900-g (2-lb) hammer; a permanent magnet; a desiccator; and an adequate volumetric apparatus. ReagentsHigh-Purity Water-The water used in these tests has a condu.:tivity at 25", as measured in an in-line cell just prior to dispensing, of not greater than 0.15 !lS per cm (6.67 Megohm-em). There must also be an assurance that
Humbolt Manufacturing Co., 7300 West Agatite Avenue, Norridge, Il, 60706, www.humboldtmfg.com

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250-mL conical flask of resistant glass, and wash it with six 30-mL portions of acetone, swirling each time for about 30 seconds, and carefully decanting the acetone. After washing, the specimen should be free from agglomerations of glass powder, and the surface of the grains should be practically free from adhering fine particles. Dry the flask and contents. for 20 minutes at 140, transfer the grains to a weighing
2Asuitable nuclear-grade resin mixture of the strong acid cation exchanger in the hydrogen form and the strong base anion exchanger in the hydroxide form, with a one-to-one cation to anion equivalence ratio, is available from the Millipore Corp, 290 Concord Road Billerica, MA, 01821, www.millipore.com; Barnstead International, 2555 Kerper Boulevard Dubuque, lA, 52004, www.barnsteadthermolyne.com; GE Water, 4636 Somerton Road Trevose, PA, 19053, www.gewater.com; Pall, 2200 Northern Boulevard East Hills, NY 11548, www.pall.com; Whatman, 200 ParkAvenue F!orham Park, NJ. 07932, www.whatman.com.; Siemens Water Technologies, 14950 Heathrow Forest Pa, Houston, TX 77032, www.usfilter.com ,

introducedduringthe crushing.Transfer specimen toa the

through

it to remove

particles

of iron that

may pe

'A suitable

mortar

and pestle is available (catalog

No. H-17280)

from

@
rjtt~;,ahdco61'ina'deskcator:
wjthitl48~hoUrs(lfterdrying;'

PhysiCal 'Tests 1<66Q)Cbhtainers-Glass257 Ampules-PI~ceat leas~6dry:~mpules on a flat, horizont~1surface, and fillthem with PUrified aterfrom a buret W until the water reaches point A, where the body of the ampule decreases to the shoulder of the ampule (see Figure2). Read the capacities, expressed to 2 decimal places, and Galculate the mean value. This volume, expressed to 1 decimal place, is the fillingvolume for the particular ampule lot. The fillingvolurne ma~ a!so be determined 'by weighin~.

Use,the test specimen "', ," , ' -c


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?rocedur~:fr~ijsf~r~'Q,;()O 9 gftheprepared spetimen, ,.curat~ly weigfi'ed, to a 250-inL Conical flask that has been i;;[1ested(aged) previou~lYviith High-PurityWater ina bath

,}i)p.O!11Lpf1;:tigh:t'Jf.ritY:~W(]ter.to:.tHlsJlask <injltq ~ne simi-,; . jaf!Yl?r~par~to provlcjea ?'ank. Cap all flaskswlth boroslll!{:ate,glass beakers that previously have been treated as desCfib~d for the flasks and. thati:!re of such,,S,iz~ 'that the :bottQms of try~,,~9kers ,fIt s!)uglydo\yn, ()I1Jhe,top rimspf 'the containers. Place the cbntai"erSTntM'autociave, and do>e it: secure'!yilEiaving the,vent Cock open.: Heat un.til 'f5tam 1ssues'vIgorously from the vent coc-k,and'contlntje 1-teating"forlO 'minute~:CI()se:th~ vent Cocki:and adjust the temperature to '1 21:0, taking l? t~23 minu:te~'toreachthe des:i-ed temperatUre. Hold the temperature at 121 :t 2.0 for 30 minutes,' counting from the,time this temperature is reached. Reduce'The 'heats? that the 'autoclave cools and ;cGmesto atrrj(:~s1?hericpressurejn 38 t040 minutes, being vent2dil~ ne~~s~ry ~o'prevent the fgrrnatioQ9fa vacuum. Lc)O'the',flask-?~<>.r1ciflru?flirig water,'de<~nt,th~~ater froT: the.flask 'intOa'suitablydeaiised v~ssel,'andwash'the'c Te;dualpowClered;glas~"wittf;four lS-mL pOrtiofisOf HighPi."XycWatr;jCiq<;fihg~h,.dec~hted washings to the main " ['O! GUI'on:Ac;iclS qrops,:ofMethyl~ep, Solution,~nCl titr;:lte im"' inec:J3.teiywithO.020 NsulfuriC add. If the\volume of titratillo s0!utionis expected to be less than 10 mL, use a mfcoburet. Record the volume of 0.020 N sulfuric acid used ~tGneutralize th~ extract froQ:lJOg of the prepared speci. meil of gla ss " c orrecte d for a blank The volUm e does not
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Figure 2. Filling Volumes of Ampules (up to'point

A)

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Glas~test
;

'Limits .',", L'mt. of :0.020 N "Acid ,'1.0"

Test--,-The-determinationis'carried out on unused containers. The"volumesof the1:estliqoid necessary for the fina! ;d~t:rrnination a~e.indicatedin Table3.
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vOmme;Qf Test1.iquid and Number ofTitrat:ions


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I - "Volume of TeSt
"'Liquid for One -, ,..Titr.a'tlon,(mL'
, 25.0.. """,,50.0 400.0 " ~~"

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f,,-)~~nj!19P:-Reni~"any'-~arisdr'dh~.:~ShQrtIY'~oFe the .test;'rins~~acl1contain~r ,(:iirefully.at.lea5t-.twke;-withf.:Purified '~9ter., and, 'allgW,to .stand. Immedicitelybefore testing, ,ernpty, thecontaine~s, ,rin~e O!1c~~!th Purified Water, then ,~m,1ID'a!~~-o..Nt1~',fj"'"9'9Iume:;,)rheftJ~il1g vol,;" ,ii.', with CarbOn D;oxide;;Ffee'WaterariclaHowto drain. 'Com)'~be;~pJym~i~i'be',fiUg9'f..' .Jllifjg4;,;w:qtec:!n t.h,~;,~;:If: ~:st~~~~~~~:~5t~:~~~6{~J:;~!~~~r~~fi~i~8t~~.~0:at ner-.t()r,the:purposeof the:;,", ,bW c~pacitY"fF,or" iVials ~OO\~ro~~~'~;%) of,~f?~'~pmf~1: ~*,*"p~s,; ,-'"'' .', d()s~ampules in ii,water bath\or ,in,art-air.-oven-aVaboat ~Oo ~or aPfJroxi~ately -f, minutes before ,',opeojng. ,Dp nOI:""", ',;j~;:th~'lP~I!m~'cue:,t!?;'~~.'1~ig~tof:~,~;!fro~Jperi; ',' 1!~ttl~~el~~,abr(i'ldom;j),contBine~':flpm f'I~.befo~(,testlng.,,",}";":;:; ',"'", ".,;"";"t,,,c ", Filling and lieating~ The rof'itaiiiers';irefillecf',\vithCdr> 'oonr[J.;oxide.;liree;Wtiterup'lo,lbe"filling, :voluTe.toC>6ntainers ~9hofD:'1'9:: '!Nace.'tt1e(.cont?me~ :'on[aihori:z:o!1talF,'3~ imtheifolJTi.ofcartridg~s'ur':prefiUed;syringes.-;are.'tI()seti,ina aod-.fiUtliem-with.'Plirifiei}'Watento aboutthe ,rim"'. suitable,roonnerwith?n'1ateiial.that 'does ,not.,interfere with 'oidirig:overlloWal1d 'introd~ctioTl;:of2air:bUbble~.",i""" the ,!test., Eath<ontainer;inCiudingarnp\Jles/ sball'b~.;/oQsely eJiguig'1eY,els/to;the:brimfuL.tine. ,\\ieigh,:theJilleti ,ta,pped.with'an.J~ert~pater~a.1 ,~ufh1~.S~,dis~.Qf,neutJ:a!l,glass, ;S:~ff)Tj\jtam':tne':m~ss,-ofthe,#iiter, ~expr.essed,to:2j .' , orc.alurnlnom Jodfm'!VIOu~Iy;;rwsedNVItniRu1Jfiep'Water/',Place ",p1a~es;-'ro1"(;t)ntainers'having,arnonjinalM>1urne.1ess tha~~ontainej;$..ontbe,tray.,.qrtl;1E!in}toclaveil:;;j",~,\,;,,,;, 'i. s ." , Wn~o',-30,mLjiang,-expr.$ed,to :JJdecimal: plac-e for :i; i;~'Placeithe-ttayc;inti:le autotlaVeJ:ontairnng:..'afquantity ,of ,.' ' ners;)baving-a:l1ginjna1;volume1g~ter:,tpan:?O[J}L.":':'T w'atelj:St1chtthat the lray/remains,dear ofthe:iWater;,:Ciose,1i3te'theimean',valuei'of:ihe'(Qrimfokcltpaditytn,mt,:;and the ':au1qQave,Jand:carryout .theJQllowingi,6perations:",~, ' (jit~~:2::]:hi~~~()lur'ne, ,e)(f1~~et:i~()\~"d~~l]1;atd;2': ,:;~J;)..h,eiit~tbe::aUtodaveXto:lOO~\andallow the steam to:, ,.
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",'j,;:1 1ssuefi;om~the'vent'cockforJQminutes;

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(2)\close:.the vent ,cockand 'faisethe temperature Jrom' ' 100 to 121 at a rate of 1 per minute;

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(3) maintain tlJ,e temperature. at 121.:!: 1Jor 6q:!: 1 minutes'.."',,""'

(4) 'lower the t~ffiperatt,lrefrom 1,21~ 100,at arate '.of ,to ",0.5 ~rmiri.ute,venting t'o,preventa v~,cuu.m;, '. '(.$),do noto.~n 'l~;auj:oclave Qefor~it hasf;:.ooleddown
.,t:o 95;,

0.020 Nsulfuric acid use!=!,c-orrected for a blank ob , by titrating 100 mL of High-Purity Water';9t,the ~mE perature and with the same amount of indici'ltor.,Tt ume ;does not exceed that indicated if) TabJe5.
:fable S. Test Limit for Water )\ttack at .1.21, , . limits
':~1 2:'General 'Oescriotiona Tre1!e? sodalime glass .. Type of ':Test . Water At;,. tack' .i". ""1 Sizeb mL . 100 or less OverlOO ,;~ "Q

(6) 'remove tI1econtainers from the autocl;weusing nQr'- mal precputions,placethemin 9,water bath,atBO" arid rUricold tap water, taking care,that the water does not contact the loosefoil.caps to avoidcontami, nation of the extraction Sci,lution;
, .

(7) tooling tilJle does hotexceecf 30 minutes. .Theextractiori solutions are analyzed by,titration according to the method described gelpw.,. Method-ymyout the tiy-atioQ ~ithin '1,hour of removal of the containers,from the autoclave. ' Combine the liquids obtained:from the containers, and mix. Introduce the prescribedvolumemdicated in Table3 into a conical flask.Placethe same volume of CarbonDioxidecFree Waterinto a se<:ondsitnilarflaskas a blank. Add 0.05mL of Methyl Red'Solutionto'each flaskfor-each 25 mL of liquid. Titrate the blankwitfi0.01 tv!hydrochtoric cid. a Titrate the test liquidwith the same acid until the color of the resulting solution is the same astl)atobtained for the blank..Subtractthevalue found for the blank titration from that found for thetestJiquid, and express ther~sults, in mL of o.ol'M hydrochlorieacid pef.,JOO,mL. Xpress E titration' values of less than 1.0 mL to 2 decimalplaces and titration values of 'more than or equal to 1.0mL to 1 decimal place. Umi~The results, brthe.average'of the results if more than One titration is"perforineq,are not greater than the values~ted in::Iqf;1le-{.i ..i ,"",); ::, :' ;:~ .
,ri:~<i/')'I'able
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. The desc~iption ~pplies' to conrainers of,,0is type of ~glass !JSualiya~ b Si2e ind.icates tj1e oV'!!rflowcapa:ity,.'t~coFll:ainer,
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~articles(pharmaceuti~als/6101 gics, dietiiry supp!eipei)f$., ;and.petliceS).1?~niti9nS:~_.Rply to,~t/:1i~J.N'ter:a~ d ,Videdin theA>reservatjon,7!.ii. 'ging" Stoi-cige/-t1na tab seetionof;the--'General "!t}Wes. nd Requir-ements:-;)\i}n and1:ests'fO'r:the'JfunctiOha1', -, -perties: of t~ntainers
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.,,~~~i~:"tiif4~qi~i:i~~~:,.:.'
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-~i~ addition:to tbestandards providedh-erein,the.i entsadded t<fthe P9,tymerS" ,d thoSE; used in the, " fabrication of.tlie c(jntairfe"r's>'' ust"toilform to the mel)ts in ,tl}E;!ap,plicable~ctios:qf the Code 9f ~e lations, ,Title 2,:) 'hiiret(RJ,bd' ; d,itiw!s;orhav~ ,bee,,!. ated bY. the 'FDA and;:getermi d to 15e:acceptable :,;1'
subStances,for

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Plasticc~hides:are'itJkfttifjM 'ntl characterizedbyeJR troscopy"and differermal scan ng calorimetry.Standa , pr()videddn.. this chapter for th ~dentjfjcation,--and sOa;;

the

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mmotes"tnStecid'Of'" ./ "esj'laRden<iing' WJth'~o prevent the;-@rmatioo~ia.V'a41um'''y~p~ ,the,amtents'from JfOr mor,ei~ontai~rfjqto'ia,;-t~~!Jr~uated,cylinder/Lcombjn~ ilJg;;~~~~E~~i;Contai,Rers"the."contents of.sev~ral cant;ainers1'Ol:)t;rinja .oJiiJOQ;rpLiPJace'the' p~ed ., :' ~};a~'1Z5 \pf resistant 9 la~s,~d5 specunen h., .' , "~~,i)*: . ' . drops ,pt Meth.yhRtl(rso~IO,.. .'. 'Ji!nq:titrate;wrode,,~{.Wjth ,, , . .

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zation,ofthe,.differmH:ypes;O, plastic, and the,test'~. dares.are,provided:at1:he.end fthe.chapter. ,The d teSting 1s'based on 'whetherD not the container has contact--witbthe drugprodutt ',.andtherisk,1s based route',Of:administtatioh../..) " ",,>\'-.. Plasticsiare..composed,of a . ixture oLhomoJogouSt11 polymers, hav.inga range of,m leCtJlar werghts.cPlasti< contain, other ,substances such sresidues fr9fP,the po izatiori process, plasticizers,'sta ilizers"antioxidants,'pi ments;';andlubric~nts.:rhese m terials'meetthe.requn

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