Description

Docetaxel Metabolite M4 is a key pharmacologically active metabolite of the widely used chemotherapy agent Docetaxel. This compound is of significant importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and the development of analytical reference standards. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in oncology drug development, bioanalytical method validation, and metabolic pathway elucidation.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the quantification and qualification of Docetaxel and its metabolites in biological matrices during clinical and non-clinical studies.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic fate, clearance pathways, and exposure levels of Docetaxel in preclinical and clinical settings.
• Bioanalytical Method Development: Used as a standard to develop and validate sensitive HPLC-MS/MS or LC-MS methods for therapeutic drug monitoring (TDM) and pharmacokinetic analysis.
• Impurity Profiling: Employed in the identification and control of potential degradants or metabolic impurities in Docetaxel drug substance and finished pharmaceutical products.
• Toxicology and Safety Assessment: Aids in understanding the safety profile and potential toxicities associated with Docetaxel's metabolic pathways.
• Academic and Institutional Research: Supports fundamental research in cancer biology, chemoresistance mechanisms, and the optimization of taxane-based chemotherapy regimens.

Basic Information

Product Name	Docetaxel Metabolite M4
CAS No.	157067-34-0
Molecular Formula	C₄₃H₅₃NO₁₄
Molecular Weight	807.88 g/mol
Synonyms	7-Epidocetaxel; 7-epi-Docetaxel; Docetaxel Impurity F (EP); (2R,3S)-N-Carboxy-3-phenylisoserine, 13-ester with 5β,20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate; Taxotere Metabolite M4; RP 56976 Metabolite M4; NSC 628503 (Metabolite)
EINECS	Contact for details

Quality Control

Our Docetaxel Metabolite M4 is manufactured and controlled under a strict quality management system. Each batch undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods (NMR, IR, MS), purity determination by HPLC, and control of specific impurities. We provide full traceability and Certificates of Analysis (COA) are available for every lot, detailing all test results against established specifications. The product is suitable for use as a pharmaceutical reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). For long-term storage, consider storing at -20°C. The product is hygroscopic (moisture-sensitive) and should be kept in a dry environment. Allow the container to reach room temperature before opening to prevent condensation.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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