Description

Betamethasone Impurity 31 CAS NO 1240591-58-5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for Betamethasone and related corticosteroid products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance. The availability of this well-characterized impurity standard is essential for accurate identification and quantification during stability studies and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Betamethasone Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to separate and detect process-related impurities.
• Stability Studies & Forced Degradation: Employed to monitor impurity profiles in stability-indicating methods, helping to establish shelf-life and storage conditions for Betamethasone formulations.
• Quality Control & Batch Release: A critical component in the quality control workflow to ensure batches of Betamethasone meet stringent pharmacopeial (USP, EP, BP) specifications for impurity limits.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary data on impurity characterization and control strategies for health authorities like the FDA and EMA.
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemical behavior of Betamethasone under various conditions.

Basic Information

Product Name	Betamethasone Impurity 31
CAS No.	1240591-58-5
Molecular Formula	C22H29FO5
Molecular Weight	392.46 g/mol
Synonyms	9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione Impurity 31; Betamethasone Related Compound 31; 16β-Methyl-9α-fluoro-1,4-pregnadiene-11β,17α,21-triol-3,20-dione Impurity; Betamethasone EP Impurity I; Betamethasone Process Impurity; (11β,16β)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione related substance
EINECS	Contact for details

Quality Control

Our Betamethasone Impurity 31 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques including HPLC, NMR, and Mass Spectrometry. We adhere to relevant industry standards for reference materials, supporting compliance with ICH Q3A/B guidelines and pharmacopeial requirements. Certificates of Analysis (COA) are available upon request and with every shipment.

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. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
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 ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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