| Testing items | Specifications | Results |
| Description | White to pale yellowish-white,crystalline powder | Conforms |
| Solubility | Freely soluble in dimethylformamide 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 | Conforms |
| Identification | Infrared absorption | Conforms |
| Related substances | Famotidine related compound D ≤0.3% | 0.03% |
| Famotidine related compound C ≤0.3% | Undetected | |
| Famotidine cyanoamidine ≤0.2% | Undetected | |
| Famotidine related compound F ≤0.1% | 0.01% | |
| Famotidine amidine ≤0.2% | Undetected | |
| Famotidine related compound B ≤0.3% | Undetected | |
| Famotidine related compound E ≤0.3% | Undetected | |
| Any other individual impurity ≤0.1% | 0.09% | |
| Total impurities ≤1.0% | 0.49% | |
| Heavy metals | ≤10ppm | Conforms |
| Loss on drying | ≤0.50% | 0.20% |
| Sulphated ash | ≤0.10% | 0.05% |
| Residual solvents | Ethanol ≤0.5% | 0.12% |
| Assay | 98.5%~101.0% | 99.50% |
| Conclusion: The Product Conforms to USP/CP. | ||
