SPECIFICATION
| Pharmacopoeia | EP9.0 |
| Appearance | White or almost white crystals |
| Appearance of solution | Clear (2.2.1) and colorless (2.2.2 Method II) (2.2.29) |
| Identification: | |
| B: IR-spectrum | Consistent with the spectrum of metformin hydrochloride CRS (2.2.24) |
| E: reaction of chlorides | It gives reaction of chlorides. (2.3.1) |
| Related substances: (2.2.29) | |
| Cyanoguanidine (impurity A) | ≤0.02% |
| Any other impurity | ≤0.05% |
| Adenine | ≤0.05% |
| Total impurities | ≤0.2% |
| Impurity F | ≤0.05% |
| Heavy metals | ≤10ppm (2.4.8) |
| Loss on drying | ≤0.5% (2.2.32) |
| Sulphated ash | ≤0.1% (2.4.14) |
| Residual solvents (Methanol) | ≤3000ppm |
| Assay on dry basis | 98.5% ~ 101.0% (2.2.20) |
Molecular Structure:
Molecular Formula: C4H12ClN5
Molecular Weight: 165.62
Description: Metformin hydrochloride is a white crystal or crystalline powder with a melting point of 232°C (218-220°C), odorless, bitter taste, easily soluble in water, soluble in methanol, slightly soluble in ethanol, and insoluble in ether and chloroform.
Application:
Metformin hydrochloride is a biguanide hypoglycemic agent. Its main function is to reduce the secretion of glucagon in A cells, promote the conversion of glucose into glycogen, and has the property of not stimulating the secretion of insulin by pancreatic β-cells.
The mechanism of hypoglycemic action is as follows:
1. Increase the sensitivity of surrounding tissues to insulin and increase insulin-mediated glucose utilization.
2. Increase the utilization of glucose by non-insulin-dependent tissues, such as brain, blood cells, renal medulla, intestine, skin, etc.
3. Inhibit liver gluconeogenesis and reduce liver glycogen output.
4. Inhibit the uptake of glucose by intestinal wall cells.
5. Inhibit the biosynthesis and storage of cholesterol, reduce blood triglycerides and total cholesterol levels.
Clinically, metformin hydrochloride is mainly used to treat patients with type 2 diabetes who are not satisfied with simple diet control, especially those with obesity and hyperinsulinemia. It not only has the effect of lowering blood sugar, but also may have the effect of reducing body weight and hyperinsulinemia. It can be effective for patients with poor efficacy of certain sulfonylureas, such as combined use with sulfonylureas, intestinal glycosidase inhibitors or thiazolidinedione hypoglycemic agents, which is better than separate use. It can also be used for patients undergoing insulin therapy to reduce the amount of insulin.
Packing :25kgs / drum
Storage：Be kept airtight, dry and in cool place.
Shelf Life :36 months from date of production when stored in good condition.
Minimum Order:500kgs
