专着可待因codeine phosphate tablets2759-磷酸盐片.pdfVIP

USP35OfficialMonographs/Codeine2759

»CodeinePhosphatecontainsnotlessthan99.0for4hours:theIRabsorptionspectrumofapotassiumbromide

percentandnotmorethan101.5percentofdispersionoftheresiduesoobtainedexhibitsmaximaatthe

CHNO·HPO,calculatedontheanhydroussamewavelengthsasthatofthecodeineobtainedbysimilarly

1821334treating1mLofasolutionofUSPCodeinePhosphateRS(1in

basis.100).

Packagingandstorage—Preserveintight,light-resistantB:AvolumeofInjection,equivalenttoabout60mgofco-

containers.Storeupto40°aspermittedbythemanufacturer.deinephosphate,respondstoIdentificationtestBunderCodeine

Phosphate.

USPReferencestandards〈11〉—Bacterialendotoxins〈85〉—Itcontainsnotmorethan5.8

USPCodeinePhosphateRSUSPEndotoxinUnitspermgofcodeinephosphate.

Identification—pH〈791〉:between3.0and6.0.

A:InfraredAbsorption〈197K〉.Limitofmorphine—Dilutedwithwatertoaconcentrationof

B:Neutralizeasolution(1in50)with6Nammoniumhy-5mgofcodeinephosphatepermL,itmeetstherequirements

droxide,andaddsilvern