Description

Methylprednisolone Impurity CAS NO 1746-38-9 is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the identification, quantification, and control of process-related impurities in the synthesis of Methylprednisolone, a widely used corticosteroid. It is primarily utilized by analytical chemists and quality control professionals in the pharmaceutical industry to ensure drug safety, efficacy, and regulatory compliance. The availability of this well-characterized impurity standard is fundamental for method validation and maintaining the highest standards in pharmaceutical manufacturing.

Application

• As a certified reference standard for analytical method development and validation in pharmaceutical QC laboratories.
• For use in impurity profiling and stability studies of Methylprednisolone Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Critical in pharmacopeial testing to comply with USP, EP, and ICH guidelines for impurity identification and qualification.
• Employed in process chemistry research to understand and optimize the synthesis pathway of Methylprednisolone.
• Serves as a key component in regulatory submissions (e.g., to FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Used for calibrating analytical instruments such as High-Performance Liquid Chromatography (HPLC) and Mass Spectrometry (MS) systems.

Basic Information

Product Name	Methylprednisolone Impurity
CAS No.	1746-38-9
Molecular Formula	C22H30O4
Molecular Weight	358.47 g/mol
Synonyms	11β,17,21-Trihydroxy-6α-methylpregna-1,4-diene-3,20-dione; 6α-Methylprednisolone; 6-Methyl-δ1-hydrocortisone; 6α-Methylprednisolone; 6α-Methyl-11β,17α,21-trihydroxy-1,4-pregnadiene-3,20-dione; 6-Methylprednisolone; NSC 527579; Methylprednisolone Related Compound
EINECS	Contact for details

Quality Control

Every batch of Methylprednisolone Impurity (CAS 1746-38-9) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with relevant specifications. We support compliance with ICH Q3A, Q3B, and pharmacopeial (USP/EP) guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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