注射用头孢噻吩质量及检验方法.pdfVIP

2590Cephalothin/MonographsUSP35

diumRS;Wisthequantity,inmg,ofCephalothinSodiumUSPReferencestandards11—

takentopreparetheAssaypreparation;andrUandrSaretheUSPCephalothinSodiumRS

cephalothinpeakresponsesobtainedfromtheAssaypreparationUSPEndotoxinRS

andtheStandardpreparation,respectively.Constitutedsolution—Atthetimeofuse,itmeetsthere-

quirementsforConstitutedSolutionsunderInjections1.

Specificrotation781S:ween+124°and+134°,calcu-

latedonthedriedandsodiumbicarbonate-freebasis.

CephalothinInjectionTestsolution:aknownamountofspecimen,equivalentto

about50mgofcephalothin,permL,inwater.

»CephalothinInjectioncontainsanamountofBacterialendotoxins85—Itcontainsnotmorethan0.13

CephalothinSodiumequivalenttonotsthanUSPEndotoxinUnitpermgofcephalothin.

90.0percentandnotmorethan115.0percentSterility71—Itmeetstherequirementswhentestedasdi-

rectedforMembraneFiltrationunderTestforSt