Description

Docetaxel is a potent semi-synthetic taxane derivative widely recognized as a key chemotherapeutic agent. Its primary value lies in its mechanism of action, which stabilizes microtubules to inhibit cell division, making it a cornerstone in oncology treatment protocols. This high-purity active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers and research institutions developing and producing injectable formulations for cancer therapy.

Application

• Oncological Formulations: Primary active ingredient in injectable chemotherapy drugs for the treatment of breast, non-small cell lung, prostate, gastric, and head/neck cancers.
• Pharmaceutical R&D: Critical component in preclinical and clinical research for developing novel anti-cancer therapies and combination regimens.
• Generic Drug Manufacturing: Sourcing of API for the production of bioequivalent generic versions of branded docetaxel products.
• Drug Delivery System Development: Used in research for advanced delivery mechanisms such as nanoparticle carriers or targeted conjugates to improve efficacy and reduce side effects.
• Reference Standard: Serves as a high-purity analytical standard for quality control testing in pharmaceutical laboratories.

Basic Information

Product Name	Docetaxel
CAS No.	125354-16-7
Molecular Formula	C43H53NO14
Molecular Weight	807.88 g/mol
Synonyms	Taxotere; RP 56976; NSC 628503; (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; Docetaxel Anhydrous; Docetaxel Trihydrate
EINECS	Contact for details

Quality Control

Our Docetaxel is manufactured under strict quality management systems, targeting compliance with ICH Q7 guidelines and relevant pharmacopoeial standards (e.g., USP, EP). Every batch undergoes comprehensive analytical testing including identity, purity, and impurity profile verification. A detailed Certificate of Analysis (COA) documenting all test results is provided with each shipment to ensure full traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C) or as specified on the label. The 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 spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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