ItemStandardSpecificationsAppearanceShouldbewhitesolidWhiteSolidIdentificationShouldbeH-NMR,MSConfirmedM.PShouldbe105-110℃106.5℃LossindryingShouldbe0.5%0.35%WaterShouldbe≤5000ppm100ppmEt
Item Standard Specifications Appearance Should be white solid White Solid Identification Should be H-NMR,MS Confirmed M.P Should be 105-110℃ 106.5℃ Loss in drying Should be 0.5% 0.35% Water Should be ≤5000ppm 100ppm Ethyl acetate Should be ≤880ppm 200ppm Residue on ignition Should be ≤0.2% 0.19% Heavy Metals Should be ≤20ppm Confirmed Bacteria endotoxins Should be ≤0.4USP EU/mg 0.2EU/mg Single impurity Should be ≤0.3% 0.15% Total impurities Should be ≤1.0% 0.46% Assay(HPLC) Should be 98.0%-102.0% 99.2%
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