Sr. No | Test | Specification | |
1 | Description | White crystals | |
2 | Solubility | Freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. | |
3 | Identification | A. Melting Point: - 222 deg C. to 226 deg C. | |
B. IR Spectrum: - Examine by infrared absorption spectrophotometer, comparing with the spectrum obtained with Metformin hydrochloride. | |||
C. By TLC: - The principal spot in the chromatogram obtained with the test solution is similar in position, color and size to the principal spot in the chromatogram obtained with reference solution. | |||
D. Color test: - A pink color develops | |||
E. Chloride: - It gives reaction of chlorides. | |||
4 | Appearance of solution | Solution (10% in water) is clear and colorless | |
5 | Related substance by HPLC | Cyanoguanidine | N. M. T. = 0.02% |
Any other Impurity | N. M. T. = 0.1% | ||
Total Impurity | N. M. T. = 0.3% | ||
6 | Heavy metals | Not More Than 10 PPM | |
7 | Loss on drying | Not More Than 0.5% | |
8 | Sulphated ash | Not More Than 0.1% | |
9 | Assay | 98.5% - 101.0% |