Description

Clobetasone Butyrate Ep Impurity C is a high-purity reference standard specifically identified as an impurity of the corticosteroid Clobetasone Butyrate. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this specific impurity during drug substance manufacturing. It is an essential material for analytical method development, validation, and quality assurance in the production of steroid-based active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Clobetasone Butyrate Ep Impurity C in API batches.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Used in-house by API manufacturers and third-party testing laboratories to ensure drug substance purity and specification compliance.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways in stability testing of Clobetasone Butyrate.
• Research & Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this specific impurity during synthesis.

Basic Information

Product Name	Clobetasone Butyrate Ep Impurity C
CAS No.	639817-49-5
Molecular Formula	C26H32ClFO5
Molecular Weight	478.98 g/mol
Synonyms	21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-butyrate; Clobetasone Butyrate Impurity C; Clobetasone 17-Butyrate Impurity C; Clobetasone Butyrate Related Compound C; 17-Butyryl Clobetasone Impurity; EP Impurity C of Clobetasone Butyrate
EINECS	Contact for details

Quality Control

Our Clobetasone Butyrate Ep Impurity C is manufactured and characterized under strict quality systems to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques including HPLC, GC-MS, and NMR. The material is qualified against relevant pharmacopeial standards (EP/BP) for use as a reference standard. We are committed to GMP-compliant practices for pharmaceutical impurities, ensuring data integrity and reliability for your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (on dried basis)	98.0% - 102.0%

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