4426 procaine hydrochloride and epinephrine injection4425-盐酸丙烯酸肾上腺素注射.pdf

USP35OfficialMonographs/Procaine4425

naphtholin10mLofsodiumhydroxidesolution(1in10),and

shake:ascarlet-redprecipitateisformed.ProcaineHydrochlorideInjection

C:ItrespondstothetestsforChloride〈191〉.

Meltingrange〈741〉:between153°and158°.»ProcaineHydrochlorideInjectionisasterileso-

Bacterialendotoxins〈85〉—WherethelabelstatesthatPro-lutionofProcaineHydrochlorideinWaterforIn-

caineHydrochlorideissterileormustbesubjectedtofurtherjection.Itcontainsnotlessthan95.0percent

processingduringthepreparationofinjectabledosageforms,itandnotmorethan105.0percentofthelabeled

containsnotmorethan0.6USPEndotoxinUnitpermgofpro-amountofCHNO·HCl.

cainehydrochloride.132022

Sterility〈71〉—Itmeetstherequirementswhentestedasdi-Packagingandstorage—Preserveinsingle-doseorinmulti-

rectedforMembraneFiltrationunderTestforSterilityoftheProd-ple-dosecontainers,preferablyofTypeIorTypeIIglass.The

ucttobeExamined.Injectionmaybepackagedin100-mLmultiple-dosecontainers.

Acidity—Toasolutionof1.0gin25mLofwateradd1drop

ofmethylredTS,andtitratewith0.020Nsodiumhydroxide:USPReferencestandards〈11〉—

notmorethan0.50mLisrequiredforneutralization.USPEndotoxinRS

Lossondrying〈731〉—Dryitoversilicagelfor18hours:itUSPProcain