利培酮COA原料药COA-USP36生产厂家
2020-11-05
来源：星星旅游
WuhanBiocarBio-PharmaceuticalCo.,LtdCertificateOfAnalysisFormNo.:R/QA-025-MP/04-4PRODUCTNAMEBATCHNO.BATCHQTYPACKAGINGQTYTESTITEMSTWSTREFERENCETESTRisperidone2014072223.33kg5FulltestUSP34CERTIFICATESAMPLESOURCEPACKAGESIZEMFG.DATERECEIPTDATEREPORTDATERETESTDATEOFANALYSISRESULTSAlmostwhitepowderPracticallyinsolubleinwater,freelysolubleinmethylenechloride,sparinglysolubleinethanol(96percent)Itdissovesindiluteacidsolutions.ConformstospectrumofRisperidoneCRSClearandcolourless0.02%0.02%1000ppm60ppmLessthandisregardlimit0.05%UndetectedUndetectedUndetectedUndetectedLessthandisregardlimit0.15%99.9%WorkshopOne5kgperbag20140722201407232014072320160721SPECIFICATIONAppearance:WhiteoralmostwhitepowderCharactersSolubility:practicallyinsolubleinwater,freelysolubleinmethylenechloride,sparinglysolubleinethanol(96percent).Itdissovesindiluteacidsolutions.ConformstospectrumofRisperidoneCRSThesolutionisclearandcolourlessNMT0.5%NMT0.1%EthanolNMT5000ppmN,N-dimethylformamideNMT880ppmImpurityAImpurityBImpurityCImpurityDImpurityEImpurityKNMT0.2%NMT0.2%NMT0.2%NMT0.2%NMT0.2%NMT0.15%IdentificationInfraredAbsorptionAppearanceofsolutionLossondryingSulfatedashResidualsolventsRelatedsubstancesSingleunknownimpurityNMT0.10%TotalimpuritiesNMT0.3%Assay99.0percentto101.0percent(driedsubstance)Reviewedby:LIANGHUIConclusion:TheabovematerialcomplieswithEP7.4Writtenby:LUOXINApprovedby:GAOJIN