Saxagliptin
ProductName:SaxagliptinBatchNo.:111011CASNO.:361442-04-8QUANTITY1GSTANDARDEnterpriseStandardItemStandardSpecificationsResultAppearanceShouldbewhitesolidWhiteSolidConfirmedIdentificationShou
Product Name:Saxagliptin Batch No.:111011 CAS NO.: 361442-04-8 QUANTITY 1G STANDARD Enterprise Standard Item Standard Specifications Result Appearance Should be white solid White Solid Confirmed Identification Should be H-NMR,MS Confirmed Confirmed M.P Should be 105-110℃ 106.5℃ Confirmed Loss in drying Should be 0.5% 0.35% Confirmed Water Should be ≤5000ppm 100ppm Confirmed Ethyl acetate Should be ≤880ppm 200ppm Confirmed Residue on ignition Should be ≤0.2% 0.19% Confirmed Heavy Metals Should be ≤20ppm Confirmed Confirmed Bacteria endotoxins Should be ≤0.4USP EU/mg 0.2EU/mg Confirmed Single impurity Should be ≤0.3% 0.15% Confirmed Total impurities Should be ≤1.0% 0.46% Confirmed Assay(HPLC) Should be 98.0%-102.0% 99.2% Confirmed CONCLUSION: It complies with all the requirements of the Enterprise standard
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