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Amlodipine Nitroso Impurity
| Chemical Name | Amlodipine Nitroso Impurity |
|---|---|
| CAT No. | CS-EO-01203 |
| Status |
|
| Category | Impurities |
| Mol. Wt. | 437.9 mol/g |
| Mol. For. | C20H24ClN3O6 |
| Hazardous | This is not a Hazardous Compound |
| COA | View Sample COA |
Additional Information
| Packing | Product will be supplied in Vials, in certain conditions we also use 'Septa Vials' |
|---|---|
| Controlled | No |
| Parent API | Amlodipine |
| Hazardous | No |
Usage and description
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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