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포함 사항: HPLC, MASS/LC-MS, 1H NMR, FT-IR, 함량, 구조 규명 보고서(SER), 그리고 제품에 따라 추가 분석 데이터가 제공됩니다.

77074-42-1Methylprednisolone Hydrogen Succinate EP Impurity B

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카탈로그 번호:	VE0025671
CAS 번호:	77074-42-1
분자식:	C26H34O8
분자량:	474.55 g/mol

견적 요청

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모약물

Methylprednisolone

IUPAC명

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

설명

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.