Sr. No. | Test | Specification |
1 | Description | A white or almost white,hygroscopic , crystalline powder |
2 | Solubility | Freely soluble in water, very slightly soluble in ethanol (96 %) |
3 | Identification | By Thin-Layer Chromatography: Results A : the principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with reference solution (a). Result B : the principal spot in the chromatogram obtained with the test solution is similar in position, colour in daylight, fluorescence in ultraviolet light at 365 nm and size to the principal spot in the chromatogram obtained with reference solution |
4 | Appearance of solution | Solution S should clear and not more intensely coloured than reference solution B7 |
5 | pH | Between pH 7.5 to 9.0 |
6 | Specific Optical Rotation | Specific optical rotation : +94 ° to +100° (an Hydrous substance) |
7 | Related Substances | Single Impurity : NMT 2.0% One Such Impurity : NMT 1.0% Total Impurity : NMT 3.0% |
8 | Inorganic Phosphate | NMT 1.0 % |
9 | Water Content (By KF) | NMT 8.0 % w/w |
10 | Assay (By UV) | NLT 96.0 % to NMT 103.0 % w/w on Anhydrous substance |