Description

Methylprednisolone Ep Impurity E CAS NO 229019-44-7 is a specified impurity of the corticosteroid Methylprednisolone, critical for analytical reference and quality control in pharmaceutical development and manufacturing. This compound is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies involved in the research, production, and quality assurance of steroid-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Methylprednisolone API and finished drug products.
• Method Development and Validation: Critical for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control impurity profiles during API synthesis and formulation to comply with pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation of degradation products in stability testing of Methylprednisolone under various storage conditions.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., with FDA, EMA) to demonstrate product safety and quality.
• Research and Development: Supports impurity profiling and characterization studies during the drug development process.

Basic Information

Product Name	Methylprednisolone Ep Impurity E
CAS No.	229019-44-7
Molecular Formula	C22H30O5
Molecular Weight	374.47 g/mol
Synonyms	Methylprednisolone Impurity E; 6α-Methylprednisolone 17-Ethyleneketal; 6α-Methylprednisolone 17,21-Acetonide; 11β,17α,21-Trihydroxy-6α-methylpregna-1,4-diene-3,20-dione cyclic 17,21-acetal with acetaldehyde; Methylprednisolone Acetonide Related Compound E; Methylprednisolone EP Impurity E
EINECS	Contact for details

Quality Control

Our Methylprednisolone Ep Impurity E is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. Each batch undergoes comprehensive analytical characterization, including HPLC for purity determination and spectroscopic methods for structural confirmation. A detailed Certificate of Analysis (COA) is provided, documenting identity, purity, and impurity profile. Our quality commitment aligns with the standards expected for pharmaceutical impurities and reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is light-sensitive; prolonged exposure to light should be avoided. Keep the container in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 1.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.