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1338549-01-111b,21,21-Trihydroxy-6a-methylpregna-1,4-diene-3,20-dione

● Under Development

Catalogue No.:	VE0021416
CAS No.:	1338549-01-1
Mol. Formula:	C22H30O5
Mol. Weight:	374.47 g/mol

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Additional information on CAS 1338549-01-1

Parent drug

Methylprednisolone

IUPAC Name

(6S,8S,9S,10R,11S,13S,14S,17S)-17-(2,2-Dihydroxyacetyl)-11-hydroxy-6,10,13-trimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-3-one

Pharmacopoeial Synonyms

N/A

Other Synonyms

N/A

Smiles

O=C1C=C[C@]2(C)[C@@]3([H])[C@@H](O)C[C@]4(C)[C@@H](C(C(O)O)=O)CC[C@@]4([H])[C@]3([H])C[C@H](C)C2=C1

Description

11b,21,21-Trihydroxy-6a-methylpregna-1,4-diene-3,20-dione (CAS 1338549-01-1) is a polar steroidal impurity encountered in corticosteroid syntheses and in stability studies of related actives. It is typically generated by over-hydroxylation, inadvertent side reactions or oxidative degradation of parent intermediates under harsh reaction or storage conditions. Analytical characterization relies on LC-MS/MS and stability-indicating HPLC methods with UV or charged aerosol detection for quantitation and HRMS and 1D/2D NMR for structural confirmation. Even at trace levels this impurity can affect assay accuracy, potency and shelf life, therefore it requires targeted control strategies, validated analytical methods and qualification according to regulatory guidelines.