Beijing Mesochem Technology Co., Ltd.  

Product Name: Valued High Quality Chemical API Osimertinib  Mesylate Model NO.: 1421373-66-1 Purity: >99% State: Solid Suitable for: Adult Certification: GMP Powder: Yes Trademark: Mesochem Transport Package: Aluminum Foil Bag and Cardboard Bucket Specification: gram&kg Origin: China HS Code: 2934999090 Product Description Certificate of AnalysisProduct Name: OsimertinibMesylateCASNo.:1421373-66-1BatchNo.HF170916Quantity56.5kgsMfg. DateSep. 16, 2017PackageAs requiredRep. DateSep. 19, 2017Exp. DateSep. 15, 2019ItemsStandardsResultsAppearanceWhite to light yellow solid powderLight yellow solid powderIdentificationBy IRCompliesBy HPLCCompliesSolubilitySoluble in Dimethylsulfoxide,slightly soluble in Ethanoland Acetonitrile,with pH dependent aqueous solubility CompliesWater Content(KF)≤1.00%0.46%Residue on Ignition≤0.10%0.07%Heavymetals≤20ppmCompliesMesylate15.20%~18.20%16.80%Residual SolventsAcetonitrile: ≤410ppmNDAcetone: ≤5000ppm1200ppmTetrahydrofuran: ≤720ppmNDRelatedSubstancesMaximum singleimpurity: ≤0.20%0.03%Total impurities: ≤1.00%0.10%Assay(HPLC basis on drying)98.00%~102.00%99.93%Particle SizeD90: ≤100µmCompliesReference StandardIn-house StandardConclusionThe productcompliedtoIn-housestandard.StoragePreserve in tight,light-resistant containers in a cool place