Methylprednisolone EP Impurity D；150899-33-5
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E-mail: anna@molcoo.com
Product Number: M038023
English Name: Methylprednisolone Acetate EP Impurity D
English Alias: 2-((6S,8S,9S,10R,11S,13S,14S,17S)-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)-2-oxoacetaldehyde
CAS Number: 150899-33-5
Molecular Formula: C₂₂H₂₈O₄
Molecular Weight: 356.46
As a specific impurity of Methylprednisolone Acetate (EP-specified), this compound has the following advantages:
Well-defined with distinct functional groups: Contains a steroidal cyclopenta[a]phenanthrene core, 11-hydroxy, 3-oxo groups, and chiral centers, differing from methylprednisolone acetate by 17-position 2-oxoacetaldehyde side chain (vs. acetoxy). Aldoketone polarity enables clear differentiation via reversed-phase HPLC/LC-MS as a specific impurity marker;
High stability and traceability: Rigid steroidal tetracyclic structure ensures stability under neutral conditions. As a byproduct of abnormal 17-side chain oxidation in synthesis, it directly reflects side chain modification selectivity, improving process tracing accuracy;
High detection sensitivity: UV absorption (230-250nm) from steroidal conjugation with aldehyde, combined with characteristic mass response (m/z 357 [M+H]⁺), enables trace analysis (ppb level) via LC-MS, compatible with steroidal aldoketone impurity systems.
Pharmaceutical quality control: Used as an EP reference standard to quantify Methylprednisolone Acetate EP Impurity D in APIs/formulations, ensuring compliance with EP standards for 17-side chain modification impurities;
Synthesis optimization: Optimizing 17-acetylation (acylating agent dosage) by monitoring impurity levels to enhance target acetoxy side chain formation;
Impurity profile enrichment: Supporting regulatory filings by supplementing methylprednisolone acetate’s impurity profile to meet international pharmacopoeial requirements.
Methylprednisolone acetate, a glucocorticoid, features a 17-acetoxy side chain for anti-inflammatory activity. Incomplete acetylation or abnormal oxidation at C17 may generate 2-oxoacetaldehyde derivatives like Methylprednisolone Acetate EP Impurity D. Pharmacologically inactive and listed as a controlled impurity in EP, its control is critical for methylprednisolone acetate quality assurance.
Current research focuses on:
Analytical method validation: Developing UPLC-DAD assays with C18 columns for baseline separation, achieving 0.05% quantitation limits per EP standards;
Side chain modification kinetics: Studying impurity formation under varying oxidation conditions to clarify 17-position reactivity mechanisms;
Process refinement: Controlling impurity levels below 0.1% via optimized acetylation parameters to meet EP specifications;
Structural confirmation: Using ¹H/¹³C-NMR to verify steroidal core and 17-aldoketone side chain, distinguishing from methylprednisolone acetate for authoritative impurity identification
We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
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