Levosulpiride; Benzamide,5-(aminosulfonyl)-N-[(1-ethyl-2-pyrrolidinyl)methyl]-2-methoxy-, (S)-;o-Anisamide, N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-sulfamoyl-,( 57362859, 57109603,-)- (8CI);(-)-Sulpiride;L-Sulpiride; Levobren; Levopraid;
APPEARANCE: FINE, WHITE, CRYSTALLINE, ODORLESS POWDER
APPEARANCE |
FINE, WHITE, CRYSTALLINE, ODORLESS POWDER |
IDENTIFICATION |
A B C IN PASS |
RESIDUAL SOLVENTS |
ETHANOL (III)<0.5% |
SOLUBILITY |
VERY SOLUBLE IN WATER, SOLUBLE IN ALCOHOL; INSOLUBLE IN ETHER AND BENZENE |
USP REFERENCE STANDARDS |
USP TETRACAINE HYDROCHLORIDE RS USP ENDOTOXIN RS |
CHROMATOGRAPHIC PURITY |
CONFORMS |
OTHER REQUIREMENTS |
CONFORMS |
ACIDITY |
CONFORM |
WATER |
≤2.0% |
RESIDUE ON IGNITION |
≤0.10% |
ASSAY |
98.5-101.0% |
