Description

Betamethasone Valerate Related Compound A (50 Mg) (Betamethasone 21-Valerate) (As) is a high-purity analytical reference standard, specifically the 21-valerate ester of betamethasone. This compound is critical for quality control and analytical method development in the pharmaceutical industry, ensuring the accuracy and reliability of assays for betamethasone valerate drug substances and products. It is an essential material for research and development scientists, quality assurance laboratories, and manufacturers requiring precise impurity profiling and validation of corticosteroid-based formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Betamethasone Valerate and its related substances in accordance with pharmacopeial monographs (USP, EP, BP).
• Impurity Profiling & Control: Serves as a specified impurity (Related Substance A) in the quality control testing of bulk active pharmaceutical ingredients (APIs) and finished dosage forms containing Betamethasone Valerate.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC), for potency and purity assays.
• Stability Studies: Employed as a marker in forced degradation and shelf-life studies to monitor the formation of specific degradation products in betamethasone valerate formulations.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed characterization and control of impurities.
• Research & Development: Used in preclinical and clinical research to understand the metabolism, pharmacokinetics, and comparative analysis of corticosteroid esters.

Basic Information

Product Name	Betamethasone Valerate Related Compound A (50 Mg) (Betamethasone 21-Valerate) (As)
CAS No.	2240-28-0
Molecular Formula	C27H37FO6
Molecular Weight	476.58 g/mol
Synonyms	Betamethasone 21-Valerate; 9α-Fluoro-11β,17α,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 21-valerate; Betamethasone Valerate EP Impurity A; Betamethasone Valerate Related Compound A; Betamethasone 17-Valerate (common misnomer); NSC 39460; SQ 15102; Valerate ester of Betamethasone
EINECS	Contact for details

Quality Control

This analytical standard is manufactured and tested under strict quality control protocols to ensure identity, purity, and stability. Each batch is characterized using advanced spectroscopic and chromatographic techniques, including NMR, Mass Spectrometry, and HPLC, against qualified reference standards. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for assay, related substances, and residual solvents, supporting compliance with ICH guidelines and major pharmacopeias.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-30°C (59-86°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 1.0%

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