Famotidine
| Appearance | White to pale yellowish-white crystalline powder |
| Solubility | Freely soluble in dimethylform-amide and in glacial acetic acid; slightly soluble in methanol; very slightly soluble in water; practically insoluble in acetone, in alcohol, in chloroform, in ether, and in ethyl acetate. |
| Identification | IR Absorption: |
| Consist with the spectra obtained with Famotidine CRS. | |
| Related Substance | Related compound B ≤0.3% |
| Related compound C ≤0.3% | |
| Related compound D ≤0.3% | |
| Related compound E ≤0.3% | |
| Related compound F ≤0.1% | |
| Cyanoamidine ≤0.2% | |
| Amidine ≤0.2% | |
| Any other individual impurity ≤0.1% | |
| Total impurity≤ 1.0% | |
| Loss on Drying | ≤0.5% |
| .Residue on Ignition | ≤0.1% |
| Heavy metals | ≤10ppm |
| Residual solvents | Ethanol≤0.5% |
| Acetone≤0.5% | |
| Assay | ≥98.5% |
| Function | It contains a thiazole ring and has a strong inhibitory effect on gastric acid secretion. The duration of action is the longest in this class of drugs. No anti-androgen and inhibition of metabolic enzymes. Famotidine can significantly inhibit the reduction of glycoprotein content in the gastric mucosa of rats induced by stress, and continuous administration can promote the healing of chronic ulcers. Double-blind contrast experiments in animal experiments and clinical upper gastrointestinal bleeding have demonstrated that famotidine has a hemostatic effect. This product also has the effect of protecting experimental gastric mucosal damage and increasing blood flow of gastric mucosa. This product does not change the rate of gastric emptying, does not interfere with pancreatic function, no teratogenic, carcinogenic, inhibition of liver drug enzymes and inhibition of androgen. |
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