Description

Clobetasone Butyrate Ep Impurity F is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) clobetasone butyrate by enabling the accurate identification and quantification of this specific impurity. It is an essential material for research laboratories, quality assurance units, and regulatory affairs departments within the pharmaceutical and biotechnology industries.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of Impurity F in clobetasone butyrate drug substances and finished products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity analysis.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control the levels of specified impurities, ensuring batch-to-batch consistency and compliance with pharmacopeial standards (EP, USP).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CMC sections) to demonstrate comprehensive impurity characterization and control strategies to agencies like the FDA and EMA.
• Stability Studies: Used as a marker to track the formation of degradation products in clobetasone butyrate formulations under various stress conditions.
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing purer synthetic routes for the API.

Basic Information

Product Name	Clobetasone Butyrate Ep Impurity F
CAS No.	25120-98-3
Molecular Formula	C26H32ClFO5
Molecular Weight	478.98 g/mol
Synonyms	Clobetasone Butyrate Impurity F; 21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-butyrate; 21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-butanoate; Clobetasone 17-Butyrate Impurity F; (11β,16β)-21-Chloro-9-fluoro-11,17-dihydroxy-16-methylpregna-1,4-diene-3,20-dione 17-butyrate
EINECS	Contact for details

Quality Control

Our Clobetasone Butyrate Ep Impurity F is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines. Our quality commitment ensures reliability for your most critical analytical and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°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
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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