Description

Betamethasone Impurity 1 is a critical pharmaceutical reference standard used for the analytical profiling and quality control of betamethasone, a potent corticosteroid. This compound is essential for ensuring the purity, safety, and efficacy of betamethasone drug substances and finished products by serving as a known impurity marker. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of related substances in betamethasone Active Pharmaceutical Ingredients (APIs) and formulations.
• Analytical Method Development & Validation: A critical component in developing and validating HPLC, UPLC, and other chromatographic methods for betamethasone analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3B).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity data for stability studies and specification setting.
• Research & Development (R&D): Used in degradation studies and forced degradation experiments to understand the stability profile of betamethasone.
• Calibration Standard: Serves as a precise calibrant for analytical instruments to ensure accurate and reproducible impurity detection.

Basic Information

Product Name	Betamethasone Impurity 1
CAS No.	560-34-9
Molecular Formula	C₂₂H₂₉FO₅
Molecular Weight	392.46 g/mol
Synonyms	9α-Fluoro-11β,17α,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione; 16β-Methyl-9α-fluoroprednisolone; 9α-Fluoro-16β-methylprednisolone; Betamethasone Impurity A; Betamethasone Related Compound A; 16β-Methyl-9α-fluoro-δ¹-hydrocortisone
EINECS	Contact for details

Quality Control

Our Betamethasone Impurity 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH guidelines and major pharmacopeias.

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 product 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 reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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