CertificateofAnalysis
Product Name: Lorcaserin hydrochloride hemihydrate
CASNo.:856681-05-5
BatchNo.HF170422Quantity32.5kgsMfg. DateApr. 22, 2017PackageAs requiredRep. DateApr. 27, 2017Exp. DateApr. 21, 2019ItemsStandardsResultsAppearanceWhite to off-white crystallinepowderWhite solid powderIdentificationBy IRCompliesBy HPLCCompliesBy Chloride: It gives a reaction of ChloridePositive reactionMelting Point198.0ºC~202.0ºC198.7ºC~200.0ºCWater Content3.0%~4.5%3.60%Residue on Ignition≤0.20%0.02%HeavyMetals≤10ppmCompliesEnantiomer≤2.00%0.24%Residual SolventDichloromethane: ≤600ppmNDAcetone: ≤5000ppmNDEthyl Acetate: ≤5000ppm600ppmMethanol: ≤3000ppmNDRelatedSubstancesMaximum singleimpurity: ≤0.50%0.07%Total impurities: ≤1.00%0.09%Purity(EE)≥ 99.0%99.91%Assay
(HPLC basis on drying)98.0%~102.0%99.92%Reference StandardIn-house StandardConclusionThe productcompliedtoIn-housestandard.StoragePreserve in tight,light-resistant containers in a cool place