Description

Clobetasone Butyrate Ep Impurity E is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound serves as a specified impurity in the synthesis and purification of the active pharmaceutical ingredient Clobetasone Butyrate, a topical corticosteroid. It is essential for laboratories and manufacturers engaged in method development, validation, and ensuring compliance with stringent pharmacopeial monographs from the European Pharmacopoeia (EP) and other regulatory bodies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Impurity E in Clobetasone Butyrate API and finished drug products.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, or GC methods to monitor impurities during API manufacturing.
• Quality Assurance & Control (QA/QC): Used in-house by API manufacturers to establish impurity profiles, set specifications, and ensure batch-to-batch consistency.
• Regulatory Compliance & Filings: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Pharmacopeial Testing: Employed to perform tests as prescribed in the European Pharmacopoeia (EP) and other international pharmacopeias for Clobetasone Butyrate.
• Stability Studies: Used to track the formation and level of this specific degradation product under various stability-indicating conditions.

Basic Information

Product Name	Clobetasone Butyrate Ep Impurity E
CAS No.	639817-48-4
Molecular Formula	C26H32ClFO5
Molecular Weight	478.98 g/mol
Synonyms	Clobetasone Butyrate Impurity E; 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 17-Butyrate Related Compound E; (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 E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards and suitability for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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