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77074-42-1Methylprednisolone Hydrogen Succinate EP Impurity B

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Catalogue No.:	VE0025671
CAS No.:	77074-42-1
Mol. Formula:	C26H34O8
Mol. Weight:	474.55 g/mol

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Additional information on CAS 77074-42-1

Parent drug

Methylprednisolone

IUPAC Name

11β,21-Dihydroxy-6α-methyl-3,20-dioxopregna-1,4-dien-17-yl hydrogen succinate

Smiles

O=C1C=C([C@@H](C)C[C@]2([H])[C@]3([H])[C@@H](O)C[C@@]4(C)C2CC[C@]4(OC(CCC(O)=O)=O)C(CO)=O)[C@]3(C)C=C1

InChI

InChI=1S/C26H34O8/c1-14-10-16-17-7-9-26(20(30)13-27,34-22(33)5-4-21(31)32)25(17,3)12-19(29)23(16)24(2)8-6-15(28)11-18(14)24/h6,8,11,14,16-17,19,23,27,29H,4-5,7,9-10,12-13H2,1-3H3,(H,31,32)/t14-,16-,17?,19-,23+,24-,25-,26-/m0/s1

Description

Methylprednisolone Hemisuccinate Related Compound B (Methylprednisolone Hydrogen Succinate EP Impurity B, CAS 77074-42-1) is a process and degradation related impurity formed via partial hydrolysis of the hemisuccinate ester of methylprednisolone. Featuring a modified succinate moiety, it is characterized and quantified at trace levels by validated reversed-phase HPLC with LC-MS confirmation and 1H NMR for structural assignment. Control measures target esterification and hydrolysis parameters, drying and pH optimization, and specification limits aligned with ICH Q3A Q3B qualification criteria. Comprehensive impurity profiling and stability indicating assays support routine batch release and regulatory compliance.