Description

10-Methyl Docetaxel-D3 is a deuterated analog of the potent anticancer agent docetaxel, specifically labeled with three deuterium atoms. This compound is a critical stable isotope-labeled internal standard used in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is essential for pharmaceutical R&D, contract research organizations (CROs), and analytical laboratories focused on oncology drug development and regulatory compliance.

Application

• Bioanalytical Reference Standard: Primary use as an internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of docetaxel and its metabolites in biological matrices (plasma, serum, tissue).
• Pharmacokinetic & Metabolism Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Drug Impurity Profiling: Assists in the identification and quantification of process-related impurities and degradants during pharmaceutical manufacturing and quality control.
• Regulatory Submissions: Supports data packages for regulatory authorities (e.g., FDA, EMA) by providing validated analytical methods with high specificity and accuracy.
• Stable Isotope Dilution Assays (SIDA): Fundamental component in advanced assay techniques that correct for analyte loss during sample preparation, enhancing result precision.

Basic Information

Product Name	10-Methyl Docetaxel-D3
CAS No.	1383561-32-7
Molecular Formula	C44H56D3NO14
Molecular Weight	~830.0 g/mol (Contact for exact weight)
Synonyms	Docetaxel-10-methyl-d3; (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, 10-methyl-d3; 10-Methyl-d3 Docetaxel; Deuterated Docetaxel Internal Standard; Taxotere-d3 (10-methyl analog); Isotopically Labeled Docetaxel
EINECS	Contact for details

Quality Control

Every batch of 10-Methyl Docetaxel-D3 is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. We guarantee high chemical and isotopic purity suitable for sensitive bioanalytical applications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from NMR (1H, 13C), Mass Spectrometry (MS), and HPLC for identity, purity, and isotopic enrichment. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake. For long-term storage, consider under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D3)	≥ 98.0 atom % D
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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