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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.

6β-Methylprednisolone Aceponate

● Under Development

Catalogue No.:	VE0027820
CAS No.:	N/A
Mol. Formula:	C27H36O7
Mol. Weight:	472.58 g/mol

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Parent drug

Methylprednisolone

IUPAC Name

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

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

CCC(O[C@]1(C(COC(C)=O)=O)CC[C@@]2([H])[C@]3([H])C[C@](C)([H])C4=CC(C=C[C@]4(C)[C@@]3([H])[C@](O)([H])C[C@]12C)=O)=O

InChI

InChI=1S/C27H36O7/c1-6-23(32)34-27(22(31)14-33-16(3)28)10-8-19-18-11-15(2)20-12-17(29)7-9-25(20,4)24(18)21(30)13-26(19,27)5/h7,9,12,15,18-19,21,24,30H,6,8,10-11,13-14H2,1-5H3/t15-,18+,19+,21+,24-,25+,26+,27+/m1/s1

Description

6β-Methylprednisolone Aceponate impurity presents as a related steroidal analog detected during synthetic and stability studies. Analytical profiling by HPLC with diode array detection and LC-MS confirms its retention time and exact mass consistent with methyl substitution at the 6beta position. The impurity can arise from incomplete esterification or methylation side reactions and may increase under elevated temperature or acidic conditions. Control strategies include optimized reaction stoichiometry, purified starting materials, and targeted chromatographic purification. Identification, quantitation, and specification setting per ICH Q3A and Q3B guidance are recommended to ensure safety, batch consistency, and regulatory compliance.