甲潑尼龍琥珀酸氫EP雜質(zhì)F

聯(lián)系方式：杜經(jīng)理 TEL: 17320513646(微信同號)    QQ: 2853567688

• 
  

• 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: C??H??O?

• Molecular Weight: 474.54

• Advantages

• As a European Pharmacopoeia (EP) impurity of Methylprednisolone Hydrogen Succinate, this compound has the following 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

• Methylprednisolone Hydrogen Succinate, a glucocorticoid for inflammation and immune disorders, is synthesized via succinylation of methylprednisolone. Abnormal succinic anhydride binding or incomplete reaction may generate ester impurities like Methylprednisolone Hydrogen Succinate EP Impurity F. Its presence risks affecting solubility and bioavailability, making control critical for quality assurance per EP standards.

• Research Status

• Current research focuses on:
• 
  

• 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.

聯(lián)系方式：杜經(jīng)理 TEL: 17320513646(微信同號)    QQ: 2853567688

備注：我們也可以定制相關類似物和修飾肽，提供包括高效液相色譜（HPLC）、質(zhì)譜（MS）、核磁共振氫譜（1H-NMR）、質(zhì)譜（MS）、高效液相色譜（HPLC）、紅外光譜（IR）、紫外光譜（UV）、分析報告（COA）、物質(zhì)安全數(shù)據(jù)表（MSDS）等資料。本產(chǎn)品僅用于實驗室用途！