Test Items Specification Results
Appearance White or pale-white crystalline powder White crystalline powder
Clarity and degree
of opalescence of liquids 1%ethanol and chloroform
Solution Conforms
Particle size 100-120mesh 200mesh
Identification Positive Positive
Loss on drying 0.10% MAX 0.05%
Sulphated ash 0.1% MAX 0.005%
Heavy metal 20 PPM MAX 7PPM
Melting point 117-120 degree 118.5 degree
Relationed substances
Single impurity 1.00% max
0.50%max 0.37%
0.12%
Single impurity 0.10% 0.06%
Assay (TLC) 98.00%-102.00% 99.50%
Assay (HPLC) 98.00%-102.00% 99.35%
Appearance White or pale-white crystalline powder White crystalline powder
Clarity and degree
of opalescence of liquids 1%ethanol and chloroform
Solution Conforms
Particle size 100-120mesh 200mesh
Identification Positive Positive
Loss on drying 0.10% MAX 0.05%
Sulphated ash 0.1% MAX 0.005%
Heavy metal 20 PPM MAX 7PPM
Melting point 117-120 degree 118.5 degree
Relationed substances
Single impurity 1.00% max
0.50%max 0.37%
0.12%
Single impurity 0.10% 0.06%
Assay (TLC) 98.00%-102.00% 99.50%
Assay (HPLC) 98.00%-102.00% 99.35%