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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.
599-21-3Fludrocortisone Impurity 4
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| Katalog-Nr.:: | VE0028510 |
|---|---|
| CAS-Nr.:: | 599-21-3 |
| Summenformel:: | C21H27FO5 |
| Molare Masse:: | 378.43 g/mol |
Zusätzliche Informationen zu CAS 599-21-3
Parent drug
FludrocortisoneIUPAC-Name
(8S,9R,10S,11S,13S,14S,17R)-9-fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-8,9,10,11,12,13,14,15,16,17-decahydro-1H-cyclopenta[a]phenanthren-3(2H)-onePharmacopeial Synonyms
N/ASynonyme
N/ASMILES
O=C1CC[C@]2(C)[C@@]3(F)[C@@H](O)C[C@]4(C)[C@](C(CO)=O)(O)CC[C@@]4([H])[C@]3([H])C=CC2=C1InChI
InChI=1S/C21H27FO5/c1-18-7-5-13(24)9-12(18)3-4-15-14-6-8-20(27,17(26)11-23)19(14,2)10-16(25)21(15,18)22/h3-4,9,14-16,23,25,27H,5-8,10-11H2,1-2H3/t14-,15-,16-,18-,19-,20-,21-/m0/s1Beschreibung
Fludrocortisone Impurity 4 (CAS 599-21-3) is a monitored degradation product observed in fludrocortisone synthesis and stability studies. Characterized by LC-MS and confirmed by NMR, this impurity can influence potency and impurity profile compliance if left uncontrolled. Typical analytical control employs validated reversed phase HPLC methods with relative response factor determination and orthogonal confirmation via HRMS. Root cause analysis commonly links formation to incomplete reduction or side reaction during steroid functionalization, informing process adjustments and purification strategies. Establishing specification limits, routine batch release testing, and stability trend monitoring are essential to maintain quality and regulatory acceptance.Angebot anfordern
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Verunreinigungsstruktur
Name der Muttersubstanz
CAS-Nr.:
Name der Verunreinigung
Katalog-Nr.:
Fludrocortisone Acetate / Fludrocortisone
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