Complaint
Ranitidine, sold under the trade name Zantac among others, is a medication that decreases stomach acid production. It is commonly used in treatment of peptic ulcer disease, gastroesophageal reflux disease, and Zollinger-Ellison syndrome.There is also tentative evidence of benefit for hives.It can be taken by mouth, by injection into a muscle, or into a vein
Common side effects include headaches and pain or burning if given by injection. Serious side effects may include liver problems, a slow heart rate, pneumonia, and the potential of masking stomach cancer. It is also linked to an increased risk of Clostridium difficile colitis.It is generally safe in pregnancy. Ranitidine is an H2 histamine receptor antagonist that works by blocking histamine and thus decreasing the amount of acid released by cells of the stomach.
Ranitidine was discovered in 1976 and came into commercial use in 1981. It is on the World Health Organization's List of Essential Medicines, the most important medications needed in a basic health system.It is available as a generic medication. The wholesale price in the developing world is about 0.01 to 0.05 USD per pill. In the United States it is about 0.05 USD per dose.
Specification
| Product Name | Ranitidine Hydrochloride | |
| Test Items | Specification | Test Results |
| Identification | Positive reaction | Positive reaction |
| PH | 4.5~6.0 | 5.4 |
| Loss on drying | Not more than 0.75% | 0.10% |
| Residue on Ignition | Not more than 0.1% | 0.02% |
| Chromatographic Purity | Ranitidine Related Compound B not more than 0.5% | Less than 0.5% |
| Any other impurity not more than 0.3% | Less than 0.3% | |
| The sum of all impurities not more than 1.0% | Less than 1.0% | |
| Organic volatile impurities | Meets the requirement | Meets the requirement |
| Assay(dried basis C13H22N4O3SHCl) | 97.5~102.0% | 99.8% |
| Conclusion | It complies with USP32 | |
