Fludrocortisone Impurity 4
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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

599-21-3Fludrocortisone Impurity 4

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Catalogue No.:VE0028510
CAS No.:599-21-3
Mol. Formula:C21H27FO5
Mol. Weight:378.43 g/mol

Additional information on CAS 599-21-3

Parent drug

Fludrocortisone

IUPAC 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)-one

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

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=C1

InChI

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/s1

Description

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.

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