Description

Docetaxel Trihydrate is a semi-synthetic taxane derivative and a potent antineoplastic agent. It functions as a microtubule stabilizer, disrupting cell division and inducing apoptosis in rapidly dividing cancer cells. This high-purity active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers developing injectable formulations for oncology treatments, primarily targeting breast, prostate, gastric, and non-small cell lung cancers.

Application

• Oncological Injectable Formulations: Primary active ingredient in sterile, lyophilized powders or concentrated solutions for intravenous infusion.
• Pharmaceutical R&D: Critical raw material for developing novel drug delivery systems, combination therapies, and generic oncology products.
• Anticancer Drug Manufacturing: Bulk API for the commercial production of branded and generic docetaxel-based chemotherapeutic drugs.
• Clinical Trial Materials: Sourced for use in Phase I-IV clinical studies investigating new cancer treatment regimens.
• Precision Medicine: Component in targeted therapy development due to its specific mechanism of action on microtubules.

Basic Information

Item	Detail
Product Name	Docetaxel Trihydrate
CAS No.	148408-66-6
Molecular Formula	C43H53NO14 · 3H2O
Molecular Weight	861.92 g/mol (Trihydrate)
Synonyms	Docetaxel Hydrate; Taxotere Impurity; (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 Trihydrate is manufactured and tested under strict quality systems. Each batch is analyzed to meet stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. A comprehensive Certificate of Analysis (COA) is provided, detailing results from tests such as HPLC assay, related substances, water content (KF), and residual solvents. Production can be aligned with cGMP guidelines to support regulatory filings (e.g., DMF, CEP).

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. This material 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 crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	≥ 98.5% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single unknown impurity ≤ 0.5%
Water Content (KF)	5.5% - 7.5% (Theoretical for trihydrate: ~6.27%)
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Specific Rotation	-40° to -47° (c = 1, methanol)

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