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| Test | Specification |
|---|---|
| Description | White Crystals |
| Solubility | Freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone, and in Methylene chloride. |
| Identification | Infrared absorption - Infra-red absorption spectrum of sample preparation should correspond to that of the standard preparation of Metformin Hydrochloride Chloride Test- Gives the reaction of chlorides |
| Appearance of solution | The solution should be clear and colorless |
| Related substances(by HPLC) | Impurity A - Not more than 0.02% Any other impurity - Not more than 0.1% |
| Heavy metals | Not more than 10 ppm |
| Sulphated ash | Not more than 0.1% |
| Loss on drying | Not more than 0.5% |
| Assay ( by Titrimetry ) | Not less than 98.50% and not more than 101.0 % ( On dried basis) |
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Ankleshwar gidc, Ankleshwar, Gujarat 
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