Description

Fusidic Acid Impurity J(Ep) CAS NO 13011-12-6 is a high-purity chemical reference standard, specifically identified as an epimer of Fusidic Acid Impurity J. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is primarily used by research institutions, analytical laboratories, and pharmaceutical companies involved in the production and quality assurance of Fusidic Acid and related antibiotic formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for calibrating analytical instruments and validating testing methods.
• Method Development & Validation: Essential for developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling of Fusidic Acid.
• Quality Control & Assurance (QC/QA): Used as a system suitability and identification marker in the routine batch analysis of Fusidic Acid Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files.
• Stability Studies: Employed to monitor the formation of this specific epimeric impurity during forced degradation and long-term stability testing of Fusidic Acid.
• Research & Development: Used in chemical and metabolic studies to understand the degradation pathways and isomerization behavior of Fusidic Acid.

Basic Information

Item	Detail
Product Name	Fusidic Acid Impurity J(Ep)
CAS No.	13011-12-6
Molecular Formula	C31H48O6
Molecular Weight	516.72 g/mol
Synonyms	Fusidic Acid EP Impurity J; (3β,4α,8α,9β,11α,13α,14β,16β,17Z)-13,27-Epoxy-16-(acetyloxy)-3,11-dihydroxy-4,8,10,14-tetramethyl-1,2,3,4,4a,5,6,6a,7,8,9,10,11,11a,12,13,14,15,15a,15b,16,17-docosahydro-17aH-cyclopenta[a]phenanthren-17-yl (5Z,8Z)-5,8-heptadecadienoate; Fusidic Acid Impurity J Epimer; Fusidic Acid Related Compound J(Ep)
EINECS	Contact for details

Quality Control

Every batch of Fusidic Acid Impurity J(Ep) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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