Description

Betamethasone Ep Impurity H is a specified impurity and degradation product of the potent corticosteroid Betamethasone. This compound is critical for pharmaceutical quality control and analytical method development, ensuring the safety and efficacy of the final drug product. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, reference standard preparation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Betamethasone Ep Impurity H in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities in Betamethasone.
• Quality Control & Assurance: Employed in routine QC testing to ensure Betamethasone batches comply with stringent pharmacopeial limits for related substances as per ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis of Betamethasone.

Basic Information

Product Name	Betamethasone Ep Impurity H
CAS No.	185613-71-2
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-Epimer; Betamethasone 16β-Methyl Epimer; Betamethasone EP Impurity H; Betamethasone Related Compound H; (11β,16β)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
EINECS	Contact for details

Quality Control

Our Betamethasone Ep Impurity H is manufactured and tested under strict quality systems. Each batch undergoes comprehensive analytical characterization using advanced techniques like HPLC, GC, MS, and NMR to confirm identity and purity, ensuring compliance with pharmacopeial standards. A detailed Certificate of Analysis (COA) providing batch-specific results is supplied 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. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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