| Function: | Drugs for Digestive System |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
| Type: | Chemical Reagent |
| State: | Powder |
| Volatile: | Not Volatile |
| Samples: |
|---|
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Audited Supplier | Test basis | USP40 | Shelf life: 3 years |
| Items | Specification | Results |
| Description | Whtie or pale yellow,crystalline powder,it shows polymorphism. | Pale yellow,crystalline powder,it shows polymorphism |
| Identification | ||
| IR spectrum | Obtainedspectrum consistent with ranitidine Hydrochloride CRS | Complies |
| UV spectrum | Absorptivities at 229nm and 315nm,calculated on the dried basis,do not differ by more than 3.0% | Complies |
| Chemical reaction | Should be positive reaction | Complies |
| Test | ||
| PH | 4.5-6.0 | 5.7 |
| Sulfated ash | ≤0.1% | 0.02% |
| Loss on drying | ≤0.75% | 0.27% |
| Heavy metal | ≤20ppm | <20ppm |
| Related substance | Impurity A≤0.3% | 0.112% |
| Impurity J≤0.1% | 0.042% | |
| Single unspecified impurity≤0.2% | 0.023% | |
| Total impurities≤0.5% | 0.295% | |
| Assay | 97.5%-102.0% | 99.2% |
| General Description | Ranitidine, N-[2-[[[5-(dimethylamino)methyl]-2-furanyl]methyl]thiol] ethyl]-N'-methyl-2-nitro-l,1-ethenediamine (Zantac), is a white solid, which inits hydrochloride salt form is highly soluble in water. It is anaminoalkyl furan derivative with pKa values of 2.7 (sidechain) and 8.2 (dimethylamino). Ranitidine is more potentthan cimetidine, but less potent than famotidine. Likeother H2-antagonists, it does not appear to bind to otherreceptors. Bioavailability of an oral dose of ranitidine is about 50%and is not significantly affected by the presence of food.Some antacids may reduce ranitidine absorption and shouldnot be taken within 1 hour of administration of this drug. Theplasma half-life of the drug is 2 to 3 hours, and it is excretedalong with its metabolites in the urine. Three metabolites, ranitidineN-oxide, ranitidine S-oxide, and desmethyl ranitidine,have been identified. Ranitidine is only a weak inhibitor ofthe hepatic cytochrome isozymes, and recommended doses ofthe drug do not appear to inhibit the metabolism of otherdrugs. However, there have been isolated reports of drug interactions(warfarin, triazolam) that suggest that ranitidinemay affect the bioavailability of certain drugs by someunidentified mechanism, perhaps by pH-dependent effect onabsorption or a change in volume of distribution. In addition to being available in various dosage forms asthe hydrochloride salt, ranitidine is also available as a bismuthcitrate salt for use with the macrolide antibiotic clarithromycinin treating patients with an active duodenalulcer associated with H. pylori infection. Eradication of H.pylori reduces the risk of duodenal ulcer recurrence. |
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