Tolvaptan ≥98.0% min Pharmaceutical API made in china CAS NO.150683-30-0

appearance

a white or off-white crystalline powder

identification

hplc:retention time of the major peaks is consistent with the standard preparation as obtained in the assay

ir: the infrared absorption spectrophotometry is accordant with the contrast spectrophotometry

chloride identification： positive reaction

ph

5.5~7.5

melting point

223~228℃

water

≤0.5%

related substance

any individual impurity：≤0.1%

total impurities：≤0.3%

residual solvent

methyl alcohol ≤0.3%

ethyl alcohol ≤0.5%

dichloromethane ≤0.06%

ethy acetate ≤0.5%

pyridine ≤0.02%

chloride

≤0.014%

residue on ignition

≤0.1%

heavy metals

≤10ppm

assay

98.0~102.0% of tolyaptan（c26h25cin2o3) calculated on the dry anhydrous