Amisulpride

Standard products

CAS-RN 71675-85-9
Documentation CEP/EDMF
Specification Ph. Eur.
Therapeutic use Neuroleptic Agent


Description White crystalline powder
IR Spectrum Similar to standard
Melting Point 124 – 128ºC
Colour Not more than Ref. Y6
Opalescence not more than Ref. II
Optical rotation -0.1º to +0.1º
Impurity A TLC Max.: 0.10%
HPLC known impurities Max.: 0.10%
HPLC unknown impurities Max.: 0.10%
HPLC Total impurities Max 0.3%
Chloride (ppm) Max.: 200ppm
Sulphated Ash Max 0.1%
Heavy metals Max 10ppm
Loss on drying Max 0.5%
Assay 99.0 – 101.0%

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