Description

Betamethasone Ep Impurity D CAS NO 52619-05-3 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of betamethasone-based drug products by enabling the accurate identification and quantification of this specific process-related impurity. It is an essential material for analytical chemists, quality assurance professionals, and regulatory affairs specialists working in pharmaceutical R&D and quality control laboratories. The availability of a well-characterized impurity standard is fundamental for meeting stringent global regulatory requirements for drug substance and drug product filings.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Betamethasone Ep Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Critical component in developing and validating analytical methods, such as High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC), for impurity profiling.
• Quality Control (QC) Testing: Used in routine QC testing of betamethasone and its derivatives to monitor and control impurity levels, ensuring batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., USP, EP, ICH).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of betamethasone and establish appropriate shelf-life and storage conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA, PMDA) by providing definitive characterization data for impurity identification.
• Research and Development: Facilitates process chemistry research aimed at minimizing or eliminating the formation of this impurity during the synthesis of betamethasone.

Basic Information

Product Name	Betamethasone Ep Impurity D
CAS No.	52619-05-3
Molecular Formula	C22H29FO5
Molecular Weight	392.46 g/mol
Synonyms	9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione; 16β-Methyl-9α-fluoroprednisolone; Betamethasone 16β,17α-Epoxide Impurity; Betamethasone Epoxide Impurity D; Betamethasone Related Compound D; 16β-Methyl-9α-fluoro-1,4-pregnadiene-11β,17α,21-triol-3,20-dione 16β,17α-epoxide
EINECS	Contact for details

Quality Control

Our Betamethasone Ep Impurity D is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, aligning with ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products. A detailed Certificate of Analysis (COA) is provided with each shipment, reporting results from validated methods including HPLC for assay and related substances, IR for identification, and residual solvent analysis. We support our clients' regulatory needs with full traceability and documentation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. Keep the container tightly sealed in a cool, dry, and well-ventilated place away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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