Can you provide COA, MSDS, and HPLC data?

Yes. Each batch is supplied with COA, MSDS, HPLC chromatogram, method validation data, and regulatory support documentation.

Do you offer samples for testing?

Yes, 1–5 g free samples are available for qualified buyers. DHL/FedEx shipping can be charged to the recipient or deducted from the first order.

What is your MOQ for Docetaxel?

MOQ is 1 g for R&D purposes and 100 g for commercial orders.

Do you ship internationally?

Yes, we ship worldwide via DHL, FedEx, and air cargo. Pharmaceutical-grade packaging ensures safe delivery.

What are the storage conditions?

Docetaxel should be stored at 2–8°C, protected from light, and kept in a tightly sealed container. Shelf life is 24 months.

Healthcare & Pharmaceutical Ingredients

Docetaxel 99% API Supplier | High-Purity Taxane | Factory Price

How Docetaxel Is Manufactured: From API Raw Materials to GMP-Grade Bulk Production

English Name: Docetaxel

Specification

Pharmaceutical Grade: Docetaxel ≥ 99.0% (HPLC), related substances ≤ 1.0%

Solubility: Sparingly soluble in water; typically formulated in polyoxyethylated castor oil (Cremophor EL) and ethanol for parenteral administration

Particle Size: Micronized powder ≤ 10 μm (for intravenous dispersion)

Appearance

White to off-white crystalline powder, odorless

CAS NO.：114977-28-5

Lead time: 10-15 Working Days (pharmaceutical grade)

Package

Sterile vials: 20 mg/5 mL, 80 mg/20 mL (injection solution); 50 mg/vial (lyophilized powder)

Storage: Sealed in glass vials, protected from light

Main Market: Global oncology market (North America, Europe, Asia-Pacific)

Application Scenarios

Core Properties

Molecular Formula: C₄₃H₅₃NO₁₄

Mechanism of Action:

Stabilizes microtubules by inhibiting tubulin depolymerization, leading to cell cycle arrest at G2/M phase and induction of apoptosis in rapidly dividing cells.

Key Features:

Potent antitumor activity against solid tumors

Semisynthetic taxane derivative of paclitaxel

Higher lipophilicity than paclitaxel, enhancing cellular uptake

Application Scenarios

1. Oncology Therapy

First-line & Second-line Treatments:

Breast Cancer: Administered at 75-100 mg/m² IV every 3 weeks, often combined with trastuzumab or cyclophosphamide.

Non-Small Cell Lung Cancer (NSCLC): 75 mg/m² IV with cisplatin for advanced cases, improving overall survival by 20-30%.

Prostate Cancer: Docetaxel + prednisone regimen for metastatic castration-resistant prostate cancer (mCRPC), extending median survival by 2.4 months.

Orphan Indications:

Gastric adenocarcinoma, head and neck squamous cell carcinoma (HNSCC) as salvage therapy.

2. Combination Therapies

Neoadjuvant & Adjuvant Settings:

Breast cancer: Docetaxel + doxorubicin + cyclophosphamide (TAC regimen) reduces recurrence risk by 32%.

Ovarian cancer: Combinations with carboplatin show response rates of 60-70% in advanced stages.

3. Veterinary Oncology

Canine Mast Cell Tumors: 10-15 mg/m² IV every 3 weeks, achieving partial response rates of 40-50%.

Feline Lymphoma: Used in combination protocols for drug-resistant cases.

Detection Methods

High-Performance Liquid Chromatography (HPLC):

Column: C18 (250×4.6 mm, 5μm), Mobile Phase: Acetonitrile-0.1% phosphoric acid (28:72 v/v), Flow: 1.0 mL/min, Detection: 227 nm.

Ultra-Performance Liquid Chromatography (UPLC):

Separates docetaxel from impurities (e.g., 10-DAB, paclitaxel) with resolution ≥ 2.0.

Mass Spectrometry (MS/MS):

Confirms molecular ion (m/z 808.3 [M+H]⁺) and quantifies trace residues (<0.1%).

Source & Manufacturing

Synthesis Route:

Semisynthesized from 10-deacetylbaccatin III (10-DAB) isolated from Taxus baccata needles via acetylation and functional group modification.

Process Advantages:

Higher yield than paclitaxel synthesis (15-20% vs. 5-8%)

Standardized production under cGMP conditions

Regulatory Compliance

US FDA: Approved for breast, lung, prostate cancer (1996-2004), listed in Orange Book.

EMA: Licensed for solid tumors with strict pharmacovigilance (PV) requirements.

China NMPA: Class 1 new drug approval (2002), GMP-compliant manufacturing required.

Market Trends

Biosimilar Development:

India-led manufacturers (e.g., Cipla, Sun Pharma) offer generic docetaxel at 30-50% cost of originator products.

Novel Formulations:

Nanoparticle albumin-bound docetaxel (Abraxane-like) reduces Cremophor EL-related hypersensitivity.

Liposomal docetaxel in Phase II trials for ovarian cancer.

Safety Profile

Boxed Warnings:

Myelosuppression (neutropenia 90%), severe hypersensitivity (2-5%), fluid retention (15-20%).

Administration Notes:

Premedication with corticosteroids and antihistamines required to mitigate infusion reactions.

Category: Healthcare & Pharmaceutical Ingredients

描述

1. Product Overview

Docetaxel 99% is a highly purified semi-synthetic taxane API widely used in anti-tumor formulations. Known for its strong microtubule-stabilizing activity, Docetaxel is a key ingredient in oncology products targeting breast cancer, NSCLC, prostate cancer, gastric cancer, head & neck cancers, and more.

At Zhonghong Biotech, we supply pharmaceutical-grade Docetaxel 99% manufactured under GMP-aligned production standards, with complete documentation including COA, MSDS, chromatographic profiles, method validation, and regulatory support files.

Our raw material is sourced from high-quality 10-deacetylbaccatin III (10-DAB), ensuring stable production, reliable batch consistency, and competitive factory-direct pricing for industrial buyers.

2. Botanical Source & Origin

Docetaxel is a semi-synthetic derivative of paclitaxel precursors isolated from:

Taxus chinensis,
Taxus yunnanensis,
Taxus brevifolia,
and other Taxus species.

We use 10-DAB (10-Deacetylbaccatin III) extracted from cultivated Taxus needles and branches. The semi-synthetic route ensures sustainability (no bark harvesting) and stable large-scale supply.

3. Key Technical Parameters

Parameter	Description
Product Name	Docetaxel
Purity	≥ 99% (HPLC)
CAS Number	114977-28-5
Molecular Formula	C43H53NO14
Molecular Weight	807.9
Appearance	White to off-white crystalline powder
Grade	Pharmaceutical / API
Production Method	Semi-synthetic from 10-DAB
Solubility	Insoluble in water; soluble in ethanol, methanol, DMSO
Standard	In-house + reference to USP/EP

4. Benefits & Mechanism of Action

1) Stabilizes Microtubules

Docetaxel enhances tubulin polymerization and prevents depolymerization, arresting cancer cells in the G2/M phase.
Supported by PubMed studies.

2) Broad Antitumor Activity

Indicated in multiple solid tumors, including:

Breast cancer
Prostate cancer
NSCLC
Gastric cancer
Head & neck cancer

3) Stronger Activity than Paclitaxel

Docetaxel shows:

Higher cellular uptake
Higher binding affinity to tubulin
Prolonged microtubule stabilization

4) Synergy

Used in combination with:

Carboplatin
Cisplatin
Doxorubicin
Capecitabine

5. Health & Clinical Relevance

Docetaxel is included in global oncology guidelines:

NCCN Guidelines
FDA-approved indications
EMA-approved oncology products

Mechanisms include:

Inducing apoptosis
Inhibiting angiogenesis
Blocking cancer metastasis

6. Application Guide

Docetaxel 99% is ideal for:

API manufacturing
Injection formulations
Liposome preparations
Nanoparticle formulations
Lyophilized powder production

7. Recommended Usage (for industrial formulating)

Application	Typical Use Level
Injection (concentrate)	10–40 mg/mL (in solvent systems)
Lyophilized powder	Custom formulations
Nano-carriers	As per formulation design
R&D / Lab Use	Based on protocol requirements

Note: Not for direct human use; suitable for formulation manufacturing only.

8. Best Formulation Practices

Use ethanol + polysorbate-80 system for solubilization.
Protect from light and oxidation during processing.
Maintain ≤ 25°C environment during formulation.
Use nitrogen protection if needed to avoid degradation.
Validate HPLC method for every batch.

9. Safety & Precautions

Documented cytotoxic compound—handle with PPE.
Use fume hood during production.
Store in sealed, light-resistant containers.
Follow FDA cytotoxic manufacturing guidelines.

10. Product Specifications (Docetaxel 99%)

Item	Specification	Method
Appearance	White/off-white powder	Visual
Identification	Positive	IR / HPLC
Assay	≥ 99%	HPLC
Related substances	≤ 1.0%	HPLC
Residual solvents	Conforms	GC
Loss on drying	≤ 1.0%	USP
Residue on ignition	≤ 0.2%	USP
Specific rotation	+28° to +34°	USP

11. COA – Pesticides, Heavy Metals, Microbiological Testing

A) Pesticide Residues (USP / EP / ChP)

Pesticide Test	Limit	Method
Organochlorine pesticides	≤ 0.1 mg/kg	GC-MS
Organophosphorus pesticides	≤ 0.1 mg/kg	GC-MS
Pyrethroid pesticides	≤ 0.1 mg/kg	GC-MS
Carbamate pesticides	≤ 0.1 mg/kg	LC-MS/MS
Total pesticide residues	Conforms	GC-MS / LC-MS/MS

B) Heavy Metals (ICP-MS / AAS)

Heavy Metal	Limit	Method
Lead (Pb)	≤ 2 ppm	ICP-MS
Arsenic (As)	≤ 1 ppm	ICP-MS
Cadmium (Cd)	≤ 1 ppm	ICP-MS
Mercury (Hg)	≤ 0.1 ppm	ICP-MS
Total Heavy Metals	≤ 10 ppm	USP <233>

C) Microbial Testing (USP <61>/<62>)

Microbial Item	Limit	Method
Total Plate Count (TPC)	≤ 1000 cfu/g	USP <61>
Yeast & Mold	≤ 100 cfu/g	USP <61>
E. coli	Negative	USP <62>
Salmonella	Negative	USP <62>
Staphylococcus aureus	Negative	USP <62>
Pseudomonas aeruginosa	Negative	USP <62>

12. Production Process (Public Version)

Semi-synthetic Production Route from 10-DAB

Raw Material Extraction
Extraction of 10-deacetylbaccatin III (10-DAB) from Taxus leaves.
Side-chain Synthesis
Preparation of the phenylisoserine side chain.
Esterification & Coupling
Coupling of 10-DAB with the activated side chain.
Protection / Deprotection Steps
Removing protecting groups to form the Docetaxel backbone.
Purification
Multi-step purification through crystallization and chromatography.
Drying & Milling
Controlled drying under low temperature.
Packaging
Final API packed in sterile, sealed containers.

13. Production Flowchart

10-DAB Extraction → Side Chain Preparation → Esterification → Coupling → Deprotection → Purification → Drying → Milling → Packaging → QC Release

14. Storage & Shelf Life

Store at 2–8°C, protected from light.
Keep container tightly sealed.
Shelf Life: 24 months under recommended conditions.

15. Packaging Options

1 g / 5 g / 10 g / 100 g / 1 kg
Triple-layer package:
- inner sterile bottle
- aluminum foil bag
- outer drum

Custom packaging is available.

16. Sample Policy

Free 1–5 g samples for qualified buyers.
Courier cost can be paid by recipient or deducted from order.

17. Shipping & MOQ

MOQ: 1 g (for R&D)
MOQ: 100 g (for commercial production)
Global shipping via DHL / FedEx / air cargo.
GMP-aligned bulk manufacturing.

18. Application Industries

Pharmaceutical manufacturing
Oncology API suppliers
Research institutes
Clinical formulation companies
CDMO / CRO partners

19. Application Scenarios

Injectable chemotherapy formulation
Lyophilized powder development
Nano-drug delivery systems
Oncology R&D projects
Toxicology studies

20. How to Use (for Manufacturing)

Dissolve in ethanol.
Add polysorbate-80.
Filter through 0.22 µm membrane.
Dilute to final concentration.
Aseptic filling.

21. Why Choose Shaanxi Zhonghong?

Expertise

15+ years experience in taxane API production
Professional R&D team
GMP-oriented system and validated methods

Authority

Third-party lab testing (Eurofins, SGS optional)
Full documentation: COA, MSDS, NMR, HPLC

Trust

Traceable raw materials
Batch consistency
Real factory photos and videos available

Experience

Exported to 40+ countries
Long-term cooperation with pharmaceutical companies

22. Frequently Asked Questions (FAQ)

1. What is the purity of your Docetaxel?
≥ 99% (HPLC), pharmaceutical grade.

2. Can I get a sample?
Yes, 1–5 g samples available.

3. Do you provide regulatory documents?
Yes: COA, MSDS, HPLC, method validation.

4. What’s your MOQ?
1 g for R&D; 100 g for commercial use.

5. What’s your lead time?
1–3 days for sample; 7–15 days for bulk.

23. References (PubMed / FDA / NIH)

https://pubmed.ncbi.nlm.nih.gov/
https://www.fda.gov/
https://www.ncbi.nlm.nih.gov/
Taxanes in cancer therapy – Nature Reviews Cancer
Docetaxel pharmacology – Clinical Cancer Research

Manufacturer: Shaanxi Zhonghong Investment Technology Co., Ltd.
Website: aiherba.com • Email: sales@aiherba.com / info@aiherba.com / liaodaohai@gmail.com