Amisulpride

CAS-RN......................................... 71675-85-9
Documentation.................................. CEP / EDMF
Specifications................................. Ph. Eur.

Description.................................... White crystalline powder
Melting Point.................................. 124 – 128ºC
IR Spectrum.................................... Similar to standard
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
Heavy metals................................... Max 10ppm
Sulphated ash.................................. Max 0.10%
Loss on drying................................. Max 0.5%
Assay.......................................... 99.0 – 101.0%