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0 % Toleranz bei der Produktqualität
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Dokumentation
Enthält: HPLC, MASS/LC-MS, 1H-NMR, FT-IR, Gehalt, Structure Elucidation Report (SER) sowie zusätzliche analytische Daten je nach Produkt.
228113-63-1Maralixibat Impurity 1
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| Katalog-Nr.:: | VE0028042 |
|---|---|
| CAS-Nr.:: | 228113-63-1 |
| Summenformel:: | C25H33FO4S |
| Molare Masse:: | 448.59 g/mol |
Zusätzliche Informationen zu CAS 228113-63-1
Parent drug
MaralixibatIUPAC-Name
(4R,5R)-3,3-Dibutyl-7-fluoro-4-hydroxy-5-(4-methoxyphenyl)-2,3,4,5-tetrahydrobenzo[b]thiepine 1,1-dioxidePharmacopeial Synonyms
N/ASynonyme
N/ASMILES
O[C@H]([C@@H](C1=CC(F)=CC=C12)C3=CC=C(OC)C=C3)C(CS2(=O)=O)(CCCC)CCCCInChI
InChI=1S/C25H33FO4S/c1-4-6-14-25(15-7-5-2)17-31(28,29)22-13-10-19(26)16-21(22)23(24(25)27)18-8-11-20(30-3)12-9-18/h8-13,16,23-24,27H,4-7,14-15,17H2,1-3H3/t23-,24-/m1/s1Beschreibung
Maralixibat Impurity 1 (CAS 228113-63-1) is a characterized process-related impurity encountered during synthesis and stability studies. It is monitored in the impurity profile using orthogonal analytical techniques such as HPLC-UV, LC-MS and NMR to confirm identity and quantify levels in bulk drug substance. Forced degradation experiments reveal its appearance under stress conditions, informing root cause analysis and control strategies. Accurate determination supports ICH Q3A compliance, specification setting and development of purification steps. Comprehensive documentation includes retention time, mass spectral fragmentation and spectroscopic assignment to facilitate robust quality control.Angebot anfordern
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