Description

Betamethasone Impurity 32 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of the corticosteroid Betamethasone, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for identifying and quantifying impurities in Betamethasone Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate chromatographic methods, such as HPLC and UPLC, for accurate impurity detection.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical QC laboratories to monitor impurity levels and ensure compliance with ICH guidelines and pharmacopeial standards (USP, EP).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug substance's impurity profile.
• Stability Studies: Employed as a marker to track the formation of degradation products in Betamethasone formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry R&D to study the pathways of impurity formation and to develop robust purification processes.

Basic Information

Product Name	Betamethasone Impurity 32
CAS No.	5533-97-1
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 related compound B; Betamethasone EP Impurity B; Betamethasone Impurity B; 16β-Methyl-9α-fluoro-δ¹-hydrocortisone
EINECS	Contact for details

Quality Control

Every batch of Betamethasone Impurity 32 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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 ≤ 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.