LEVOSULPIRIDE INHOUSE
TESTSSPECIFICATIONS
DescriptionA White or almost white , crystalline powder
SolubilityPractically insoluble in water ,Springly soluble in methanol and slightly in ethanol(96%)and in methylene chloride
Identification
A)By IRA)IR spectrum of test preparation should be concordant with that standard
B)Melting PointB)Between 182°C to 192°C
Apperance of SolutionThe solution is clear and not more intensely colored than reference solution BY6
Specific Optical Rotation(On dried Basis)Between -60° to -70°
Heavy MetalsMax 10ppm
ChloridesNot more than 100ppm
Sulphated AshNot more than 0.1 %
Loss on DryingNot more than 0.5 %
Related substance
A)By TLCImpurity A:Not more than 0.1 %
B)By HPLCSingle Impurity:Not more than 0.5 %
Total Impurities:Not more than 1.0 %
Assay (On Dried Basis)Between 98.5 to 101.0 %
PACKING:25Kg Fiber Drum/HDPE Drum with double inner polythene bag

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