Description

Methylprednisolone Impurity 4 CAS NO 167997-11-7 is a specified impurity of the corticosteroid Methylprednisolone, critical for analytical reference and pharmaceutical quality control. This compound is essential for ensuring the purity, safety, and efficacy of Methylprednisolone drug substances and finished products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Methylprednisolone Active Pharmaceutical Ingredients (APIs) and formulations.
• Analytical Method Development & Validation: A critical component in developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to establish impurity limits and ensure every batch of Methylprednisolone meets stringent pharmacopeial specifications (USP, EP, BP).
• Stability Studies: Used to track the formation of degradation products in Methylprednisolone under various stress conditions (heat, light, humidity) as part of ICH stability protocols.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and the development of new purification processes for Methylprednisolone.

Basic Information

Product Name	Methylprednisolone Impurity 4
CAS No.	167997-11-7
Molecular Formula	C22H30O5
Molecular Weight	374.47 g/mol
Synonyms	6α-Methylprednisolone Impurity 4; 11β,17α,21-Trihydroxy-6α-methylpregna-1,4-diene-3,20-dione related compound; Methylprednisolone Related Compound 4; 6α-Methylprednisolone EP Impurity D; 6-Methylprednisolone Impurity 4; 6α-Methyl-11β,17α,21-trihydroxypregna-1,4-diene-3,20-dione impurity
EINECS	Contact for details

Quality Control

Every batch of Methylprednisolone Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines for impurity standards.

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 material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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