| 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% |
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