3705 loperamide hydrochloride capsules3704-洛地酰胺盐酸胶囊.pdfVIP

3704Loperamide/OfficialMonographsUSP35

1-Piperidinebutanamide,4-(4-chlorophenyl)-4-hydroxy-N,N-di-

methyl-α,α-diphenyl-,monohydrochloride.LoperamideHydrochlorideCapsules

4-(p-Chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-

piperidinebutyramidemonohydrochloride[34552-83-5].»LoperamideHydrochlorideCapsulescontain

»LoperamideHydrochloridecontainsnotlessnotlessthan90.0percentandnotmorethan

than98.0percentandnotmorethan102.0per-110.0percentofthelabeledamountofloper-

amidehydrochloride(CHClNO·HCl).

centofCHClNO·HCl,calculatedonthe293322

293322

driedbasis.

Packagingandstorage—Preserveinwell-closedcontainers.

Packagingandstorage—Preserveinwell-closedcontainers.USPReferencestandards〈11〉—

USPReferencestandards〈11〉—USPLoperamideHydrochlorideRS

USPLoperamideHydrochlorideRSIdentification—

Identification—A:Thin-LayerChromatographicIdentificationTest〈201〉—

A:InfraredAbsorption〈197K〉.Testsolution—TransferaquantityofthecontentsoftheCap-

B:Transferabout40mg,accuratelyweighed,toa100-mL