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Calcium Hydroxide Topical Solution

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CalciumHydroxideTopicalSolution

CalciumHydroxideTopicalSolutionisasolutioncontaining,ineach100
mL,notlessthan140mgofcalciumhydroxide[Ca(OH)2].
PrepareCalciumHydroxideTopicalSolutionasfollows(seePharmaceutical
CompoundingNonsterile Preparations
Calcium
Hydroxide
Purified Water

795 ):

3g
1000
mL

AddtheCalciumHydroxideto1000mLofcoolPurifiedWater,andagitatethe
mixturevigorouslyandrepeatedlyduring1hour.Allowtheexcesscalcium
hydroxidetosettle.Dispenseonlytheclearsupernatant.
NOTEThesolubilityofcalciumhydroxide,whichvarieswiththetemperature

atwhichthesolutionisstored,isabout170mgper100mLat15 andlessat
ahighertemperature.Theofficialconcentrationisbaseduponatemperature
of25 .
Theundissolvedportionofthemixtureisnotsuitableforpreparingadditional
quantitiesofCalciumHydroxideTopicalSolution.
Packaging and storagePreserveinwell-filled,tightcontainers,atatemperaturenotexceeding
25 .
Identification
A: Itabsorbscarbondioxidefromtheair,afilmofcalciumcarbonateformingonthesurfaceofthe
liquid.
B: Whenheated,itbecomesturbid,owingtotheseparationofcalciumhydroxide.
C: ItrespondstothetestsforCalcium

191 .

Alkalies and their carbonatesAportionofit,saturatedwithcarbondioxideandsubsequently


boiled,isneutralinreaction.
AssayPipet100mLofTopicalSolutionintoasuitablecontainer,add50mLofwater,15mLof
1Nsodiumhydroxide,and300mgofhydroxynaphtholblue,andtitratewith0.05Medetate
disodiumVStoablueendpoint.EachmLof0.05Medetatedisodiumisequivalentto3.705mgof

calciumhydroxide[Ca(OH) 2].
Auxiliary InformationStaff Liaison:FeiwenMao,M.S.,SeniorScientificAssociate
Expert Committee:(MDOOD05)MonographDevelopment-OphthalmicsOncologicsand
Dermatologicals
USP30NF25Page1601
Pharmacopeial Forum:VolumeNo.27(6)Page3259
Phone Number:1-301-816-8320

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