Description

Clobetasone Butyrate Ep Impurity I 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, ensuring the safety and efficacy of the final drug product. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, impurity profiling, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Clobetasone Butyrate.
• Impurity Profiling & Identification: Essential for identifying, monitoring, and controlling this specific impurity during active pharmaceutical ingredient (API) manufacturing.
• Method Development & Validation: Serves as a critical component in developing and validating analytical methods, such as HPLC and LC-MS, for impurity detection.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch testing to ensure API and finished product purity meets pharmacopeial specifications (e.g., EP, USP).
• Regulatory Compliance & Submission: Supports regulatory filings by providing necessary data on impurity levels for agencies like the FDA and EMA.
• Stability Studies: Used to track the formation of this impurity over time under various storage conditions.

Basic Information

Product Name	Clobetasone Butyrate Ep Impurity I
CAS No.	639817-47-3
Molecular Formula	C26H32ClFO5
Molecular Weight	478.98 g/mol
Synonyms	Clobetasone Impurity I; 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-methyl-1,4-pregnadiene-3,20-dione 17-butyrate; Clobetasone Butyrate Related Compound I; Clobetasone Butyrate EP Impurity I; Clobetasone Butyrate USP Impurity I; Clobetasone Butyrate Impurity C (alternative nomenclature)
EINECS	Contact for details

Quality Control

Our Clobetasone Butyrate Ep Impurity I is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, supporting compliance with EP (European Pharmacopoeia), USP (United States Pharmacopeia), and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle the material 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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.