Palonosetron Hydrochloride nitrosamine impurity
| CAS No. | : NA |
| Mol F. | : C15H21N3O |
| Mol W. | : 259.35 |
| Cat No. | : SA44609 |
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Description
| Product Name | Palonosetron Hydrochloride nitrosamine impurity |
| Synonyms | N-((R)-1-phenylethyl)-N-((S)-quinuclidin-3-yl)nitrous amide |
| Related API | Nitrosamine |
| Category | Impurities |
Palonosetron Hydrochloride nitrosamine impurity product with CAS: NA is also known as N-((R)-1-phenylethyl)-N-((S)-quinuclidin-3-yl)nitrous amide. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. It is used in Nitrosamine impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, N-((R)-1-phenylethyl)-N-((S)-quinuclidin-3-yl)nitrous amide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.
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