Description

7-Epi-Docetaxel (Docetaxel Impurity C) is a critical pharmaceutical reference standard and impurity used in the research, development, and quality control of the potent anticancer drug Docetaxel. This compound is essential for ensuring the purity, safety, and efficacy of Docetaxel formulations by serving as a benchmark in analytical methods. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of 7-Epi-Docetaxel in Docetaxel active pharmaceutical ingredients (APIs) and finished drug products.
• Impurity Profiling & Control: Critical for monitoring and controlling the levels of this specific degradation product during the manufacturing and storage of Docetaxel, ensuring compliance with ICH guidelines.
• Analytical Method Development & Validation: Serves as a key component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for purity analysis.
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Docetaxel and establish appropriate shelf-life.
• Regulatory Compliance & Documentation: Used to prepare documentation for regulatory submissions (e.g., to FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research on Degradation Mechanisms: Facilitates chemical and metabolic studies to elucidate the formation pathways and biological activity of this epimer impurity.

Basic Information

Item	Details
Product Name	7-Epi-Docetaxel (Docetaxel Impurity C)
CAS No.	153381-68-1
Molecular Formula	C43H53NO14
Molecular Weight	807.88 g/mol
Synonyms	7-Epi-docetaxel; Docetaxel Impurity C; (2R,3S)-N-Carboxy-3-phenylisoserine, N-tert-butyl ester, 13-ester with 5β,20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate; 7-Epimer of Docetaxel; 7-Epi Taxotere Impurity; 7-Epimer Docetaxel
EINECS	Contact for details

Quality Control

Our 7-Epi-Docetaxel is manufactured under strict quality management systems to ensure it meets the exacting standards required for pharmaceutical impurity analysis. Each batch is subjected to comprehensive analytical testing, including HPLC purity assay, chiral purity determination, and identity confirmation (IR, MS). A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at -20°C or below under an inert atmosphere to minimize oxidation. Allow the container to reach room temperature before opening to prevent condensation and moisture ingress.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Chiral Purity (HPLC)	≥ 99.0% (7-Epi isomer)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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