Description

Clobetasone Butyrate Ep Impurity D is a high-purity chemical reference standard, specifically identified as an impurity of the corticosteroid Clobetasone Butyrate. This compound is critical for pharmaceutical research, development, and quality control processes, where precise identification and quantification of impurities are mandated by regulatory authorities. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in method validation and ensuring the safety and efficacy of steroid-based drug products.

Application

• Primary use as a certified reference standard for analytical method development and validation.
• Critical component in pharmaceutical impurity profiling and stability studies for Clobetasone Butyrate API and formulations.
• Used for calibrating analytical equipment such as HPLC, UPLC, and LC-MS systems in QC laboratories.
• Essential for regulatory compliance and filing, supporting ICH guidelines on impurities in new drug substances.
• Serves as a research tool in studying the degradation pathways and metabolism of Clobetasone Butyrate.
• Supports pharmacopoeial testing to meet EP, USP, and other international monograph requirements.

Basic Information

Product Name	Clobetasone Butyrate Ep Impurity D
CAS No.	639817-51-9
Molecular Formula	C26H32ClFO5
Molecular Weight	478.98 g/mol
Synonyms	Clobetasone Butyrate Impurity D; 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 D; Clobetasone Impurity D; EP Impurity D of Clobetasone Butyrate; (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

Every batch of Clobetasone Butyrate Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopoeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 0.5%

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