Amlodipine Nitroso Impurity
Also known as: Amlodipine Nitrosamine Impurities or nitrosamine impurities of Amlodipine| Product Name | Amlodipine Nitroso Impurity |
|---|---|
| Alternate Names | Amlodipine Impurities, Impurities of Amlodipine |
| CAT No. | CS-EO-01203 |
| CAS No. | Not Available |
| Category | Impurities |
| Stock | Enquire |
| Mol. Wt. | 437.9 g/mol |
| Mol. For. | C20H24ClN3O6 |
| Hazardous | This is not a Hazardous Compound |
| COA | View Sample COA |
| MSDS | View Sample MSDS |
| Parent API | Amlodipine |
| Controlled | No |
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| Return | Returns/replacement accepted if you are not satisfied with the quality of the product, (please send us an email with the reason/issues which are facing, within 15 days, after receipt of the product). |
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Amlodipine is a commonly prescribed medication for the treatment of hypertension and angina. It is a calcium channel blocker that works by relaxing the blood vessels and improving blood flow. However, during the manufacturing process of amlodipine, an impurity known as amlodipine nitroso impurity (ANI) can be formed.
ANI is a potentially harmful impurity that can negatively affect the efficacy and safety of amlodipine. It is classified as a nitroso compound, which means it contains a nitroso group (-NO) attached to a carbon atom. Nitroso compounds have been found to be carcinogenic and mutagenic in animal studies.
Therefore, it is essential to monitor and control the levels of ANI in amlodipine products to ensure their safety and efficacy. The acceptable limit of ANI in amlodipine products is set at 0.15% by most regulatory agencies.
Analytical methods such as high-performance liquid chromatography (HPLC) and gas chromatography-mass spectrometry (GC-MS) are commonly used to detect and quantify ANI in amlodipine products.
In conclusion, ANI is a potentially harmful impurity that can form during the manufacturing process of amlodipine. Its levels must be monitored and controlled to ensure the safety and efficacy of amlodipine products.
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Related Compounds
Amlodipine Impurity 34 | Amlodipine morpholine impurity | Amlodipine N-Lactoside | Amlodipine Galactose Adduct | Amlodipin EP Impurity D | Amlodipine EP Impurity D HCl | Amlodipine Mannitol Adduct Acetate Salt | Dehydro Amlodipine N-Oxide | Amlodipine Aspartic Acid Impurity | Amlodipine EP Impurity E Maleate | N-Nitroso Amlodipine EP Impurity F | Amlodipine EP Impurity A | Amlodipine Impurity 29 | Amlodipine Impurity 25 | Amlodipine orotate | N-Nitroso Amlodipine | Amlodipine Mannitol Adduct | Amlodipine aminoethyl | Amlodipine EP Impurity E | Deschloro Amlodipine | N-Fomyl Amlodipine | Hydroxyethyl phthalyl amlodipine | Amlodipine Impurity 32 | Dimethoxy Impurity Deschloro Amlodipine | Amlodipine Mannitol Adduct HCl Salt | Atorvastatin Amlodipine Dimer | Amlodipine Impurity 8 | Amlodipine Methyl Ester | Amlodipine Azido Impurity | Amlodipine Impurity 61 | Amlodipine N-Galactose | Phthaloyl Amlodipine Dimethyl Ester | Amlodipine EP Impurity F | Desmethyl Amlodipine | Atorvastatin-Amlodipine Adduct | Amlodipine Lactose adduct | Amlodipine Impurity 9 | Amlodipine EP Impurity G | Amlodipine Besylate Impurity D Besylate salt | Di-acid Amlodipine | Amlodipine Related Compound A | Amlodipine For Peak Identification | Amlodipine EP Impurity D Oxalate Salt | Amlodipine Impurity 38 | R-Amlodipine Besilate | Amlodipine EP Impurity H | Amlodipine Impurity F Maleate | Amlodipine Impurity | Amlodipine EP Impurity B | R-Amlodipine hemipentahydrate | Amlodipine EP Impurity C | Amlodipine Impurity 19 |