Cefixime Nitroso impurity 1
Also known as: Cefixime Nitrosamine Impurities or nitrosamine impurities of Cefixime| Product Name | Cefixime Nitroso impurity 1 |
|---|---|
| Alternate Names | Cefixime Impurities, Impurities of Cefixime |
| CAT No. | CS-O-44126 |
| CAS No. | Not Available |
| Category | Impurities |
| Stock | Enquire |
| Mol. Wt. | 482.45 g/mol |
| Mol. For. | C16H14N6O8S2 |
| Hazardous | This is not a Hazardous Compound |
| COA | View Sample COA |
| MSDS | View Sample MSDS |
| Parent API | Cefixime |
| 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). |
| Ordering | Place your order online or by email sales@clearsynth.com |
Cefixime is a third-generation cephalosporin antibiotic that is commonly used to treat bacterial infections. However, during the synthesis of cefixime, an impurity known as Cefixime Nitroso impurity 1 may be formed. This impurity is a potential concern for pharmaceutical manufacturers as it can affect the quality, safety, and efficacy of the final product.
Cefixime Nitroso impurity 1 is a nitroso compound that is formed during the reaction between cefixime and nitrous acid. Nitroso compounds are known to be potentially carcinogenic, mutagenic, and genotoxic. Therefore, it is essential to carefully monitor and control the levels of this impurity during the manufacturing process of cefixime.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has set a limit of 0.15% for the Cefixime Nitroso impurity 1 in cefixime drug substances and drug products. This limit ensures that the final product is safe for human use.
In conclusion, Cefixime Nitroso impurity 1 is a potential impurity that can be formed during the synthesis of cefixime. Pharmaceutical manufacturers must carefully monitor and control the levels of this impurity to ensure that the final product is safe and effective for human use. The ICH has set a limit of 0.15% for this impurity in cefixime drug substances and drug products.
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Related Compounds
Cefixime Impurity 1 | Cefixime EP Impurity C | Cefixime Acid, Thiazine Isomer Impurity, Disodium Salt | N-Acetyl Cefixime | Cefixime EP Impurity D | Cefixime Nitroso impurity 2 | Cefixime EP Impurity A (Mixture of Diastereomers) | Cefixime glucose adduct | Cefixime tert-Butyl Ester | Cefixime EP Impurity B | Cefixime Sulfoxide | Cefixime D2 | Cefixime | Cefixime Impurity 4 | Cefixime related compound B | Cefixime related compound A | Cefixime Methyl Ester | Cefixime Impurity 4 |