METFORMIN HYDROCHLORIDE I.P.
METFORMIN HYDROCHLORIDE I.P
Metformin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems.
SPECIFICATION FOR METFORMIN HYDROCHLORIDE I.P.
| Name Of Finished Product | METFORMIN HYDROCHLORIDE |
| Molecular Formula | C4H11N5.HCl |
| Molecular Weight | 165.62 |
| Packing | 20 kgs & 25 kgs |
| The Shelf-Life | 5 Years |
| Storage Conditions And Precautions | Store in a well-closed containers/bags. |
| NO | TEST | OBSERVATION |
|---|---|---|
| 1 | Description | A white or almost white crystalline powder. |
| 2 | Loss on Drying | Not more than 0.5%. |
| 3 | Solubility | Freely soluble in water, slightly soluble in ethanol (95%),practically insoluble in acetone, in chloroform, in dichloromethane and in ether. |
| 4 | Identification | A. By IR spectrophotometry. Compare the spectrum with that obtained with Metformin hydrochloride RS or with the reference spectrum of Metformin. B. By Chemical Test. A solution of 25mg in 5 ml of water gives orange –red colour on addition of 1.5 ml of sodium hydroxide, 1 ml of 1-nephthol solution and dropwise with shaking, 0.5 ml of sodium hypochlorite solution (3 Percent CI) which darkens on keeping. |
| 5 | Heavy Metals | NMT 20 ppm |
| 6 | Sulphated Ash | NMT 0.1% |
| 7 | Related substances (BY HPLC) Dicyandiamide Any Other impurity |
NMT 0.02% NMT 0.1% |
| 8 | Assay % w/w (On Dried Basis) | 98.5% – 101.0% |