METFORMIN HYDROCHLORIDE B.P.
METFORMIN HYDROCHLORIDE B.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 B.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 | 4. Identification A. Melting Point. Between 222°c to 226°c B. By IR Spectrum. The infrared spectrum of the sample in potassium bromide should be concordant with that of similarly recorded spectrum obtained from Metformin Hydrochloride working standard. C. By TLC. The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution. D. A Pink Colour Develops E. A Cruddy white precipitate is formed. |
| 5 | Appearance Of Solution | Solution S is clear and colourless. |
| 6 | Sulphated Ash | NMT 0.1% |
| 7 | Related substances (BY HPLC) Dicyandiamide Any Other impurity Total Impurity |
NMT 0.02% NMT 0.05% NMT 0.2% |
| 8 | Assay % w/w (On Dried Basis) | 98.5% – 101.0% |