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Documentation
Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.
Ezetimibe Nitroso Impurity 10; Synthesis Attempts and Failure Report (NAP Test)
● Report Available Immediately
| Catalogue No.: | VE0028967 |
|---|---|
| CAS No.: | N/A |
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Additional information on
Smiles
FC1=CC=C(C(CC[C@@H](C(O)=O)[C@H](N(C2=CC=C(F)C=C2)N=O)C3=CC=C(O)C=C3)=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.Description
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 10. Our findings revealed that Ezetimibe Nitroso Impurity 10 does not readily undergo nitrosation under the expected conditions, significantly reducing concerns about its potential formation.
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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 10 Information
- Molecular Weight: 454.42 g/mol
- Molecular Formula: C24H20F2N2O5
- IUPAC Name: (R)-5-(4-fluorophenyl)-2-((S)-((4-fluorophenyl)(nitroso)amino)(4-hydroxyphenyl)methyl)-5-oxopentanoic acid
- CAS Number: N/A
- Synonyms: N/A
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