Description

Betamethasone Valerate EP Impurity H is a high-purity chemical reference standard, specifically identified as a known impurity of the active pharmaceutical ingredient Betamethasone Valerate. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method development, validation, and routine impurity profiling in compliance with pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Betamethasone Valerate EP Impurity H in drug substances and finished products.
• Analytical Method Development: Essential for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity analysis.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with strict pharmacopeial specifications (EP, USP).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary data on impurity profiles for health authorities like the FDA and EMA.
• Research & Development: Utilized in stability studies and degradation pathway investigations to understand the behavior of Betamethasone Valerate formulations.

Basic Information

Product Name	Betamethasone Valerate EP Impurity H
CAS No.	52619-18-8
Molecular Formula	C27H37FO6
Molecular Weight	476.58 g/mol
Synonyms	9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-valerate; Betamethasone 17-Valerate Impurity H; 21-Desoxybetamethasone 17-valerate; Betamethasone Valerate Related Compound H; 9α-Fluoro-16β-methylprednisolone 17-valerate; 17-Valerate ester of 21-desoxybetamethasone
EINECS	Contact for details

Quality Control

Every batch of Betamethasone Valerate EP Impurity H is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 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 powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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