Description

Methylprednisolone Impurity 21 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the corticosteroid drug Methylprednisolone. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in Methylprednisolone Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor and control impurity levels, ensuring batch-to-batch consistency and compliance with pharmacopeial standards (USP, EP, ICH).
• Stability Studies: Used to identify and track degradation products that may form during the stability testing of Methylprednisolone formulations.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Supports R&D activities focused on understanding the synthesis pathways, degradation mechanisms, and metabolism of Methylprednisolone.

Basic Information

Product Name	Methylprednisolone Impurity 21
CAS No.	150899-33-5
Molecular Formula	C22H30O4
Molecular Weight	358.47 g/mol
Synonyms	6α-Methylprednisolone Impurity 21; 6α-Methylprednisolone Related Compound; 11β,17α,21-Trihydroxy-6α-methylpregna-1,4-diene-3,20-dione; Methylprednisolone EP Impurity B; Methylprednisolone USP Related Compound; 6α-Methylprednisolone-21-ol; 6-Methylprednisolone Impurity
EINECS	Contact for details

Quality Control

Every batch of Methylprednisolone Impurity 21 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and spectroscopic methods for structural confirmation, to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C.

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)	Individual impurity: ≤ 0.5% 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.