Description

7-Epi-10-Oxo-Docetaxel (Docetaxel Impurity D) is a structurally characterized impurity and degradation product of the potent anticancer drug Docetaxel. This compound is critically important for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and quality control of Docetaxel drug substances and products. It is an essential material for analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and biotechnology industries focused on oncology drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Docetaxel active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability and Forced Degradation Studies: Used to identify and track degradation pathways of Docetaxel under various stress conditions (e.g., heat, light, pH) to establish shelf life and storage recommendations.
• Quality Control & Batch Release Testing: Essential component of the impurity specification for Docetaxel, ensuring batch-to-batch consistency and compliance with pharmacopoeial standards (USP, EP, JP).
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Metabolism and Pharmacokinetic Research: Potential use as a metabolite standard in studies investigating the in vivo biotransformation and clearance pathways of Docetaxel.

Basic Information

Product Name	7-Epi-10-Oxo-Docetaxel (Docetaxel Impurity D)
CAS No.	162784-72-7
Molecular Formula	C43H53NO14
Molecular Weight	807.89 g/mol
Synonyms	Docetaxel Impurity D; 10-Oxo-7-epi-docetaxel; 7-Epi-10-oxodocetaxel; (2R,3S)-3-[[(1,1-Dimethylethoxy)carbonyl]amino]-2-hydroxy-3-phenylpropionate 10-oxo-7-epi-docetaxel; Taxotere Impurity D; NSC 628503 Impurity; 7-Epi-10-ketodocetaxel
EINECS	Contact for details

Quality Control

Our 7-Epi-10-Oxo-Docetaxel is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and conformity to the highest standards. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results for all critical quality attributes. Our quality commitment aligns with the needs of cGMP-compliant pharmaceutical research and development.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at -20°C. The compound is light-sensitive; all handling should minimize exposure to direct light.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
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.