6/9/2016

USPMonographs:Petrolatum

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Petrolatum

Petrolatumisapurifiedmixtureofsemisolidhydrocarbonsobtainedfrompetroleum.Itmaycontaina
suitablestabilizer.
PackagingandstoragePreserveinwellclosedcontainers.
LabelingLabelittoindicatethenameandproportionofanyaddedstabilizer.
ColorMeltabout10gonasteambath,andpourabout5mLoftheliquidintoaclearglass15150mmtesttube,
keepingthepetrolatummelted.Thepetrolatumisnotdarkerthanasolutionmadebymixing3.8mLofferricchlorideCS
and1.2mLofcobaltouschlorideCSinasimilartube,thecomparisonofthetwobeingmadeinreflectedlightagainsta
whitebackground,thepetrolatumtubebeinghelddirectlyagainstthebackgroundatsuchananglethatthereisno
fluorescence.
Specificgravity 841 :between0.815and0.880at60 .
Meltingrange,ClassIII 741 :between38 and60 .
Consistency
ApparatusDeterminetheconsistencyofPetrolatumbymeansofapenetrometerfittedwithapolishedconeshapedmetal
plungerweighing150g,havingadetachablesteeltipofthefollowingdimensions:thetipoftheconehasanangleof30 ,
thepointbeingtruncatedtoadiameterof0.3810.025mm,thebaseofthetipis8.380.05mmindiameter,andthe
lengthofthetipis14.940.05mm.Theremainingportionoftheconehasanangleof90 ,isabout28mminheight,and
hasamaximumdiameteratthebaseofabout65mm.Thecontainersforthetestareflatbottommetalcylindersthatare
1006mmindiameterandnotlessthan65mminheight.Theyareconstructedofatleast1.6mm(16gauge)metal,and
areprovidedwithwellfitting,watertightcovers.
ProcedurePlacetherequirednumberofcontainersinanoven,andbringthemandaquantityofPetrolatumtoa
temperatureof822.5 ,pourthePetrolatumintooneormoreofthecontainers,fillingtowithin6mmoftherim.Coolto25
2.5 overaperiodofnotlessthan16hours,protectedfromdrafts.Twohoursbeforethetest,placethecontainersina
waterbathat250.5 .Iftheroomtemperatureisbelow23.5 orabove26.5 ,adjustthetemperatureoftheconeto25
0.5 byplacingitinthewaterbath.
Withoutdisturbingthesurfaceofthesubstanceundertest,placethecontaineronthepenetrometertable,andlowerthe
coneuntilthetipjusttouchesthetopsurfaceofthetestsubstanceataspot25mmto38mmfromtheedgeofthe
container.Adjustthezerosettingandquicklyreleasetheplunger,thenholditfreefor5seconds.Securetheplunger,and
readthetotalpenetrationfromthescale.Makethreeormoretrials,eachsospacedthatthereisnooverlappingofthe
areasofpenetration.Wherethepenetrationexceeds20mm,useaseparatecontainerofthetestsubstanceforeachtrial.
Readthepenetrationtothenearest0.1mm.Calculatetheaverageofthethreeormorereadings,andconductfurthertrials
toatotalof10iftheindividualresultsdifferfromtheaveragebymorethan3%:thefinalaverageofthetrialsisnotless
than10.0mmandnotmorethan30.0mm,indicatingaconsistencyvaluebetween100and300.
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USPMonographs:Petrolatum

AcidityIftheadditionofphenolphthaleinTSinthetestforAlkalinityproducesnopinkcolor,add0.1mLofmethylorange
TS:noredorpinkcolorisproduced.
AlkalinityIntroduce35gintoasuitablebeaker,add100mLofboilingwater,cover,andplaceonastirringhotplate
maintainedattheboilingpointofwater.After5minutes,allowthephasestoseparate.Drawofftheseparatedwaterintoa
casserole,washthepetrolatumfurtherwithtwo50mLportionsofboilingwater,andaddthewashingstothecasserole.To
thepooledwashingsadd1dropofphenolphthaleinTS,andboil:thesolutiondoesnotacquireapinkcolor.
Residueonignition 281 Heat2ginanopenporcelainorplatinumdishoveraBunsenflame:itvolatilizeswithout
emittinganacridodorandonignitionyieldsnotmorethan0.1%ofresidue.
OrganicacidsWeigh20.0g,add100mLofa1in2mixtureofneutralizedalcoholandwater,agitatethoroughly,and
heattoboiling.Add1mLofphenolphthaleinTS,andtitraterapidlywith0.1NsodiumhydroxideVS,withvigorousagitation
totheproductionofasharppinkendpoint,notingthecolorchangeinthealcoholwaterlayer:notmorethan400Lof0.100
Nsodiumhydroxideisrequired.
Fixedoils,fats,androsinDigest10gwith50mLof5Nsodiumhydroxideat100 for30minutes.Separatethewater
layer,andacidifyitwith5Nsulfuricacid:nooilyorsolidmatterseparates.
Residualsolvents 467 :meetstherequirements.
(OfficialJanuary1,2007)
AuxiliaryInformationStaffLiaison:HongWang,Ph.D.,SeniorScientificAssociate
ExpertCommittee:(EM205)ExcipientMonographs2
USP29NF24Page1692
PharmacopeialForum:VolumeNo.28(2)Page569
PhoneNumber:13018168351

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