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Test | Limits |
Appearance | A white or almost crystalline powder, slightly hydroscopic |
Solubility | Very soluble in water, soluble in ethanol (96%), practically insoluble in acetone. Melts at 138⁰ C with decomposition |
Identification | Test A, B, & C comply as per procedure of BP |
Appearance of Solution | To comply as per testing procedure of BP |
Impurity A & B | To comply as per testing procedure of BP |
Related Substance | To comply as per testing procedure of BP |
Heavy Metals | NMT 20 ppm |
% LOD | NMT 0.5% w/w |
% Sulphates Ash | NMT 0.1% w/w |
% Assay by HPLC | NLT 98% and NMT 102% |