Description

Betamethasone Impurity 36 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 betamethasone-based pharmaceutical products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control (QC) and quality assurance (QA) of Betamethasone Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to accurately identify and quantify this specific impurity.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity identification and control strategies in drug dossiers.
• Stability Studies: Employed to monitor the formation and levels of Betamethasone Impurity 36 in drug substances and products under various stress and long-term storage conditions.
• Research & Development: Serves as a key reagent in pharmaceutical R&D for studying the degradation pathways and metabolism of betamethasone.

Basic Information

Product Name	Betamethasone Impurity 36
CAS No.	72559-88-7
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 Impurity F; Betamethasone Related Compound F; 16β-Methyl-9α-fluorocortisol; (11β,16β)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
EINECS	Contact for details

Quality Control

Every batch of Betamethasone Impurity 36 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive characterization is performed using advanced analytical techniques including HPLC, GC, MS, and NMR. Certificates of Analysis (COA) containing detailed batch-specific results are available upon request.

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 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 reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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