Oxytocin

Details:

COMPLY WITH USP30 STANDARD PRODUCT NAMEOXYTOCIN USP30EXPIRY DATE2 yearsCAS NO.TEST SPECIFICATION RESULTSCHARACTERISTICWHITE TO OFF-WHITE,AMORPHOUS POWDERCONFORMSIDENTITY BY MS1007.23±11007.6IDENTIFICATIONA. RETENTION TIME CONFORMS TO THAT OF REFERENCEB. BIOIDENTITYRAT TESTCONFORMS CONFORMSPH3.0-6.05.1AMINO ACIDSAsp0.95-1.05Glu0.95-1.05Pro0.95-1.05Gly0.95-1.05Leu0.90-1.05Tyr0.70-1.05Cys1.4-2.1Ile0.9-1.10    CONFORMSOXYTOCIN ACTIVITY≥400IU/mg529IU/mgORDINARY IMPURITIES(HPLC)SINGLE IMPURITY≤1.5%THE TOTAL SUM OF THE AREA OF SUCH PEAKS DOES NOT  EXCEED OF THE PRINCIPAL PEAK ≤5.0%0.26%  1.2%ACETIC ACID≤10%6.9%WATER(KF)                                ≤5.0%2.6%ENDOTOXIN LEVER≤300EU/mgCONFORMSVASOPRESSOR ACTIVITY≤0.1units/mlCONFORMSPEPTIDE PURITY(HPLC)≥95.0%98.8%BACTERIAL LIMITSLESS THAN 200ufc/grCONFORMSMeOH(GC)NOT MORE THAN 0.3%CONFORMSAcN(GC)NOT MORE THAN 0.041%CONFORMSCONCLUSION                                  MEETS USP 30 COMPLY WITH USP30 STANDARD PRODUCT NAMEOXYTOCIN USP30EXPIRY DATE2 yearsCAS NO.TEST SPECIFICATION RESULTSCHARACTERISTICWHITE TO OFF-WHITE,AMORPHOUS POWDERCONFORMSIDENTITY BY MS1007.23±11007.6IDENTIFICATIONA. RETENTION TIME CONFORMS TO THAT OF REFERENCEB. BIOIDENTITYRAT TESTCONFORMS CONFORMSPH3.0-6.05.1AMINO ACIDSAsp0.95-1.05Glu0.95-1.05Pro0.95-1.05Gly0.95-1.05Leu0.90-1.05Tyr0.70-1.05Cys1.4-2.1Ile0.9-1.10    CONFORMSOXYTOCIN ACTIVITY≥400IU/mg529IU/mgORDINARY IMPURITIES(HPLC)SINGLE IMPURITY≤1.5%THE TOTAL SUM OF THE AREA OF SUCH PEAKS DOES NOT  EXCEED OF THE PRINCIPAL PEAK ≤5.0%0.26%  1.2%ACETIC ACID≤10%6.9%WATER(KF)                                ≤5.0%2.6%ENDOTOXIN LEVER≤300EU/mgCONFORMSVASOPRESSOR ACTIVITY≤0.1units/mlCONFORMSPEPTIDE PURITY(HPLC)≥95.0%98.8%BACTERIAL LIMITSLESS THAN 200ufc/grCONFORMSMeOH(GC)NOT MORE THAN 0.3%CONFORMSAcN(GC)NOT MORE THAN 0.041%CONFORMSCONCLUSION                                  MEETS USP 30