Methylprednisolone Hydrogen Succinate EP Impurity F NEW

Product Information

Product Number: M038022

English Name: Methylprednisolone Hydrogen Succinate EP Impurity F

English Alias: 4-(2-((6R,8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-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)-2-oxoethoxy)-4-oxobutanoic acid

CAS Number: 2376134-25-5

Molecular Formula: C₂₆H₃₄O₈

Molecular Weight: 474.54

Advantages

Well-defined and distinct structure: Contains cyclopenta[a]phenanthrene steroid nucleus, dihydroxyl, ketone group, and succinic acid monoester chain, differing from the target compound in succinate linkage and esterification degree. Synergistic effects of multiple oxygen-containing groups (hydroxyl, ketone, ester, carboxyl) enable unique polarity and retention behavior, allowing accurate identification via HPLC and LC-MS as a specific impurity marker;

High stability and traceability: The conjugated system formed by steroid skeleton and multiple esters/carboxyls is stable under neutral conditions. As a by-product of incomplete succinylation, it directly reflects esterification efficiency, improving quality tracing accuracy;

High detection sensitivity: Strong UV absorption (240-260nm) from steroid conjugation, combined with characteristic mass response (m/z 475 [M+H]⁺), enables trace analysis (ppb level) via LC-MS, compatible with glucocorticoid ester derivative impurity systems.

Applications

Pharmaceutical quality control: Used as an EP reference standard to quantify Methylprednisolone Hydrogen Succinate EP Impurity F in APIs and formulations, ensuring residual esterification impurities meet EP standards;

Synthesis optimization: Optimizing succinic anhydride-methylprednisolone esterification (temperature, catalyst) by monitoring impurity levels to enhance target monoester selectivity;

Regulatory compliance: Validating impurity profile compliance with EP requirements to support EU market registration of methylprednisolone hydrogen succinate products.

Background Description

Research Status

Analytical method advancement: Developing UPLC-DAD assays with optimized mobile phase pH for baseline separation of impurity and target, achieving 0.5 ppb detection limits;

Esterification kinetics: Studying impurity formation under varying reaction conditions to clarify regioselectivity factors in methylprednisolone hydroxylation;

Stability studies: Evaluating impurity degradation under accelerated storage to guide formulation packaging design;

Pharmacopoeial method cross-validation: Verifying impurity quantification consistency across platforms to ensure EP compliance.