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内容: HPLC、MASS/LC-MS、1H NMR、FT-IR、含量、構造解析レポート（SER）、および製品に応じた追加分析データ。
Ezetimibe Nitroso Impurity 11; Synthesis Attempts and Failure Report (NAP Test)
● Report Available Immediately
| カタログ番号: | VE0028965 |
|---|---|
| CAS番号: | N/A |
に関する追加情報
SMILES
FC1=CC=C(N([C@H](C2=CC=C(O)C=C2)C(CC[C@@H](O)C3=CC=C(F)C=C3)C(O)=O)N=O)C=C1Experiments
10 synthesis attempts under recommended conditions for nitroso impurity formation. Along with HPLC, MASS/LCMS, NMR, IR performed for all 10 experimentsReport Format
Delivered in digital PDF format. Printed copies available on request (additional shipping and handling charges apply).Report Language
English by default. Certified translations available at extra cost via our third-party translation partner.説明
EMA Guidance on Nitrosamines
According to EMA guidelines, if repeated synthesis attempts fail to detect the formation of nitrosamine impurities, it is likely that the impurity either does not exist or poses an extremely low risk.
Nitrosation
We conducted multiple nitrosation assays under rigorous forced conditions (NAP tests), to evaluate the risk of Ezetimibe Nitroso Impurity 11. Our findings revealed that Ezetimibe Nitroso Impurity 11 does not readily undergo nitrosation under the expected conditions, significantly reducing concerns about its potential formation.
Request Synthesis Failure Report Quote
Our synthesis failure report provides a detailed account of the findings from our synthesis attempts and rigorous testing, demonstrating the non-formation of the nitroso impurity. It offers a comprehensive overview of the evaluated conditions and the resulting data.
Ezetimibe Nitroso Impurity 11 Information
- Molecular Weight: 456.44 g/mol
- Molecular Formula: C24H22F2N2O5
- IUPAC Name: (5R)-5-(4-fluorophenyl)-2-((S)-((4-fluorophenyl)(nitroso)amino)(4-hydroxyphenyl)methyl)-5-hydroxypentanoic acid
- CAS Number: N/A
- Synonyms: N/A
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