Description

Docetaxel Hydrate is a potent semi-synthetic taxane derivative widely recognized for its antineoplastic activity. This high-purity active pharmaceutical ingredient (API) is critical for the formulation of injectable chemotherapeutic agents. It is primarily utilized by pharmaceutical manufacturers and research institutions in the oncology sector for the development and production of life-saving cancer treatments.

Application

• Oncological Drug Manufacturing: Primary active ingredient in the commercial production of injectable chemotherapy drugs for the treatment of various cancers.
• Pharmaceutical R&D: Used in preclinical and clinical research for developing new formulations, combination therapies, and drug delivery systems.
• Generic Drug Production: Serves as the key API for manufacturers producing generic versions of docetaxel-based medications.
• Reference Standard: Employed as a high-purity analytical standard in quality control laboratories for method development and validation.
• Biochemical Research: Used in cell biology studies to investigate mechanisms of microtubule stabilization and apoptosis induction.

Basic Information

Product Name	Docetaxel Hydrate
CAS No.	700367-34-6
Molecular Formula	C43H53NO14 · xH2O
Molecular Weight	807.88 (Anhydrous basis)
Synonyms	Docetaxel Trihydrate; Taxotere (Brand Name); (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; RP 56976; NSC 628503
EINECS	Contact for details

Quality Control

Our Docetaxel Hydrate is manufactured under strict quality management systems, ensuring it meets the rigorous standards required for pharmaceutical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We adhere to relevant ICH guidelines and can supply material compliant with specifications for USP/EP monographs upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as specified on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 98.5%
Water Content (KF)	4.0% - 6.0%
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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