Description

Betamethasone Valerate EP Impurity F is a high-purity chemical reference standard, designated as a specified impurity of the corticosteroid 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 validation, stability studies, and compliance with stringent pharmacopeial monographs.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Betamethasone Valerate EP Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation (HPLC/GC): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure drug substance and drug product purity meets pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions over the shelf life of the product.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., CMC sections of ANDA, NDA) by providing necessary data on impurity characterization and control strategies.
• Research & Development (R&D): Serves as a critical tool in synthetic chemistry R&D for process optimization and impurity fate and tolerance studies.

Basic Information

Product Name	Betamethasone Valerate EP Impurity F
CAS No.	16125-28-3
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; 21-Desoxybetamethasone 17-valerate; Betamethasone 17-Valerate Impurity F; Betamethasone Valerate Related Compound F; 16β-Methyl-9α-fluoro-1,4-pregnadiene-11β,17α,21-triol-3,20-dione 17-valerate; 9α-Fluoro-16β-methylprednisolone 17-valerate; Betamethasone 21-Deoxy-17-valerate.
EINECS	Contact for details

Quality Control

Our Betamethasone Valerate EP Impurity F is manufactured and tested under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC, NMR, and MS to confirm identity, purity, and strength. We provide full traceability and a detailed Certificate of Analysis (COA) with each shipment, ensuring compliance with relevant pharmacopeial standards and internal specifications for reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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