1. Обзор продукта

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.

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2. Ботанический источник и происхождение

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

• Тис китайский,

• Taxus yunnanensis,

• Тис коротколистный,

• и другие Такс разновидность.

Мы используем 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.

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3. Key Technical Parameters

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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

• НМРЛ

• 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

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5. Health & Clinical Relevance

Docetaxel is included in global oncology guidelines:

• NCCN Guidelines

• FDA-approved indications

• EMA-approved oncology products

Mechanisms include:

• Индукция апоптоза

• Inhibiting angiogenesis

• Blocking cancer metastasis

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6. Руководство по применению

Docetaxel 99% is ideal for:

• API manufacturing

• Injection formulations

• Liposome preparations

• Nanoparticle formulations

• Lyophilized powder production

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7. Recommended Usage (for industrial formulating)

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

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8. Лучшие практики разработки рецептур

1. Use ethanol + polysorbate-80 system for solubilization.

2. Protect from light and oxidation during processing.

3. Maintain ≤ 25°C environment during formulation.

4. Use nitrogen protection if needed to avoid degradation.

5. Validate HPLC method for every batch.

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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.

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10. Product Specifications (Docetaxel 99%)

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11. COA – Pesticides, Heavy Metals, Microbiological Testing

A) Pesticide Residues (USP / EP / ChP)

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B) Heavy Metals (ICP-MS / AAS)

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

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12. Production Process (Public Version)

Semi-synthetic Production Route from 10-DAB

1. Raw Material Extraction
   Extraction of 10-deacetylbaccatin III (10-DAB) from Taxus leaves.

2. Side-chain Synthesis
   Preparation of the phenylisoserine side chain.

3. Esterification & Coupling
   Coupling of 10-DAB with the activated side chain.

4. Protection / Deprotection Steps
   Removing protecting groups to form the Docetaxel backbone.

5. Очищение
   Multi-step purification through crystallization and chromatography.

6. Сушка и измельчение
   Controlled drying under low temperature.

7. Упаковка
   Final API packed in sterile, sealed containers.

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13. Production Flowchart

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

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14. Storage & Shelf Life

• Хранить в 2–8°С, protected from light.

• Keep container tightly sealed.

• Shelf Life: 24 months under recommended conditions.

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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.

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16. Sample Policy

• Free 1–5 g samples for qualified buyers.

• Courier cost can be paid by recipient or deducted from order.

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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.

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18. Application Industries

• Pharmaceutical manufacturing

• Oncology API suppliers

• Research institutes

• Clinical formulation companies

• CDMO / CRO partners

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19. Application Scenarios

• Injectable chemotherapy formulation

• Lyophilized powder development

• Nano-drug delivery systems

• Oncology R&D projects

• Toxicology studies

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20. How to Use (for Manufacturing)

1. Dissolve in ethanol.

2. Add polysorbate-80.

3. Filter through 0.22 µm membrane.

4. Dilute to final concentration.

5. Aseptic filling.

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21. Why Choose Shaanxi Zhonghong?

Экспертиза

• 15+ years experience in taxane API production

• Professional R&D team

• GMP-oriented system and validated methods

Власть

• Third-party lab testing (Eurofins, SGS optional)

• Full documentation: COA, MSDS, NMR, HPLC

Доверять

• Прослеживаемое сырье

• Batch consistency

• Real factory photos and videos available

Опыт

• Exported to 40+ countries

• Long-term cooperation with pharmaceutical companies

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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.

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23. References (PubMed / FDA / NIH)

1. https://pubmed.ncbi.nlm.nih.gov/

2. https://www.fda.gov/

3. https://www.ncbi.nlm.nih.gov/

4. Taxanes in cancer therapy – Nature Reviews Cancer

5. Docetaxel pharmacology – Клинические исследования рака

Manufacturer: Shaanxi Zhonghong Investment Technology Co., Ltd.
Сайт: aiherba.com • Электронная почта: sales@aiherba.com / info@aiherba.com / liaodaohai@gmail.com