Anastrozole

Details:

AnastrozoleCAS-No.120511-73-1CertificationISO certificationRef.standardUSP34CertificateISO9001 AnastrozoleCAS-No.120511-73-1Molecular FormulaC17H19N5Molecular Weight293.37CERTIFICATE OF ANALYSISProduct name                  Anastrozole (Arimidex)CAS No120511-73-1Ref.standardUSP34Batch NumberNF-1104001Manu. DateFeb 6, 2012Batch Size23.2KgRe-test DateFeb 5, 2014Net Weight10gReport DateFeb 6, 2012Storage ConditionPreserve in tight, light-resistant containers, and store at 15°-30°C. TEST ITEMMethod SPECIFICATIONRESULTSDescriptionInternal methodWhite or slightly yellow crystallinepowder, homogeneous and with fine grain size. No foreign particles areobserved.White PowderSolubilityInternal methodFreely soluble in methanol ,ethanol ,ethyl-acetate and chloroform,slightly soluble in water and 0.1M hydrochloric acid solution.  ConformIdentificationIRReactiveConformConformWaterInternal methodKarl-Fischer1.0%0.8%Heavy metalsNMT 0.001%ConformConformMelting rangeInternal method82.0 – 85.0 °C83.1-84.2°C Residue on ignitionInternal methodUSP 31 or last edition 2810.1%0.07%Loss on dryingInternal method0.3%0.12%Related impurities (HPLC)MethodInternal methodHPLCImpurity BMax 0.2%0.05%Impurity CMax 0.2%0.05%Impurity DMax 0.1%0.03%Impurity EMax 0.1%0.03%Single unknown ImpurityMax 0.1%0.05%