Description

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

Application

• Oncological Pharmaceutical Manufacturing: Primary API for the production of injectable chemotherapy drugs.
• Breast Cancer Treatment: Formulation into drugs for locally advanced or metastatic breast cancer, often in combination regimens.
• Non-Small Cell Lung Cancer (NSCLC) Therapy: Used in the manufacture of therapeutics for patients with advanced NSCLC.
• Prostate Cancer Treatment: Key component in chemotherapeutic solutions for hormone-refractory metastatic prostate cancer.
• Gastric Adenocarcinoma Treatment: Utilized in combination therapy formulations for advanced gastric adenocarcinoma.
• Head and Neck Cancer Therapy: Incorporated into treatment protocols for inoperable, locally advanced squamous cell carcinoma.
• Pharmaceutical Research & Development: Serves as a reference standard and raw material for new drug development and bioavailability studies.
• Hospital & Clinical Compounding: Used by specialized pharmacies for preparing patient-specific doses within strict aseptic protocols.

Basic Information

Product Name	Docetaxel
CAS No.	114977-28-5
Molecular Formula	C43H53NO14
Molecular Weight	807.88 g/mol
Synonyms	N-debenzoyl-N-tert-butoxycarbonyl-10-deacetylpaclitaxel; 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 Trihydrate; Anhydrous Docetaxel
EINECS	Contact for details

Quality Control

Our Docetaxel is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. Certificates of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological attributes are provided and can be tailored to meet specific pharmacopoeial standards (e.g., USP, EP, JP).

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 crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 3.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Specific Rotation	-36.0° to -41.0° (c=1, in ethanol)
Bacterial Endotoxins	< 10 EU/mg
Microbial Enumeration	Complies with Ph. Eur. 2.6.12 / USP <61>

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