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1. Introduction: Why Docetaxel API Remains a Cornerstone in Oncology Formulations

Docetaxel is one of the world’s most widely used chemotherapy APIs for breast cancer, NSCLC, prostate cancer, gastric cancer, and head–neck tumors. For pharmaceutical manufacturers, Docetaxel remains a high-value, high-barrier oncology raw material, requiring uncompromising GMP control, validated analytical methods, and reliable bulk sourcing.

This article provides application insights, formulation strategies, and procurement guidance for manufacturers developing Docetaxel injections or generic oncology formulations.

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2. Docetaxel API Overview for Manufacturers (Purity, Grades, Specs)

Key manufacturing specs (commonly required):

• Assay (HPLC): ≥ 99.0%
• Identification: IR, LC–MS (per pharmacopeial standards)
• Related Substances: ≤ 0.5% total impurities
• Residual Solvents: GC tested, meets ICH Q3C
• Microbial Limits: USP <61> & <62>
• Particle Size: Injection-grade fineness
• Endotoxin: < 0.5 EU/mg (for sterile-grade intermediates)

Regulatory & Quality Compliance:

• GMP production
• DMF & CTD modules available
• COA + MSDS + TSE/BSE-free declarations
• Full traceability from raw material (Taxus spp.)

Recommended Supplier:
Shaanxi Zhonghong Investment Technology Co., Ltd.
Website: aiherba.com
Emails: sales@aiherba.com, info@aiherba.com, liaodaohai@gmail.com

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3. Application Insights: How Pharmaceutical Companies Use Docetaxel in Oncology Formulations

Docetaxel is a poorly water-soluble taxane, requiring advanced formulation engineering. Below are the most common application models:

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3.1 Conventional Docetaxel Injection (Polysorbate 80 System)

Keywords: Docetaxel Injection Formulation | Docetaxel API Supplier

This is the standard generic model used globally.

Typical excipients:

• Polysorbate 80 (solubilizer)
• Dehydrated alcohol
• Dilution with saline or glucose prior to injection

Formulation challenges:

• Polysorbate 80 hypersensitivity reactions
• Stability concerns (oxidation & hydrolysis)

Sourcing requirements:
Manufacturers require high-purity Docetaxel with:

• Tight impurity control
• Verified stability at controlled humidity
• Batch-to-batch reproducibility

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3.2 Nanoparticle & Liposomal Docetaxel Formulations

Keywords: Docetaxel nanoparticles | Liposomal Docetaxel | Docetaxel for novel drug delivery systems

Growing rapidly in global oncology pipelines.

Technology platforms include:

• PEGylated nanoparticles
• Liposomes
• Polymeric micelles
• Albumin-bound NPs

Advantages:

• Lower toxicity
• Improved tumor targeting
• Reduced solvent burden

API requirements:

• Narrow particle size distribution
• Low-level related substances
• Stability against degradation during high-shear mixing

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3.3 Docetaxel Pre-Mixed Single-Vial Formulations

Designed to eliminate polysorbate 80–related side effects.

Requires:

• Ultra-high purity Docetaxel (≥99.5%)
• Reduced epimers and oxidized impurities
• High stability suitable for ambient storage

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3.4 Docetaxel in Combination Therapies

Use cases:

• Docetaxel + Carboplatin
• Docetaxel + Cyclophosphamide
• Docetaxel + Prednisolone (prostate cancer)

Combination injectables require harmonized impurity profiles and stability data.

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4. Technical Formulation Tips for Manufacturers (Experience-Based Guidance)

Drawing on factory-level production experience and common customer feedback, the following points are crucial:

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4.1 Solubility & Stability Considerations

Docetaxel is extremely hydrophobic (logP ~4.1).
Common stability issues include:

• Hydrolysis at high humidity
• Oxidation during sterilization
• Polysorbate 80 degradation

Mitigation:

• Protect from light (amber vials)
• Nitrogen-filled packaging
• Maintain API moisture ≤ 1%

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4.2 Impurity Control Determines Final Injection Safety

Manufacturers typically track:

• 10-DAB impurities
• Oxidation byproducts
• Epimerization products

Stringent impurity removal ensures cleaner final IV infusion.

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4.3 Sterile Filtration & Vial Filling Requirements

Docetaxel solutions are viscous; filters can clog.
Recommendations:

• Pre-heat excipient solution for better flow
• Use 0.22 μm hydrophilic PVDF filters
• Conduct compatibility tests for filters and stoppers

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5. Real Industry Case Studies (Anonymous)

Case 1 — Southeast Asia Generic Oncology Plant

• Problem: High impurity levels during stability testing
• Solution: Switched to Zhonghong’s 99% Docetaxel with optimized crystallinity
• Result: 24-month stability achieved, batch pass rate ↑ 30%

Case 2 — EU Nanoparticle-based R&D Startup

• Problem: Particle aggregation in micellar formulation
• Solution: Customized micronized Docetaxel (D90 < 5 μm)
• Result: Formulation became stable and passed freeze–thaw validation

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6. Procurement Guide: How to Choose a Reliable Docetaxel Supplier

6.1 Mandatory Documents

• GMP certificate
• Batch COA
• HPLC chromatograms
• Impurity profile
• Stability data
• MSDS

6.2 Factory Audit Checklist

• Cleanroom classification
• Water system validation
• OEL handling system for high-potency compounds
• API traceability from Taxus sources

6.3 Why Pharmaceutical Manufacturers Choose Zhonghong (aiherba.com)

• Direct GMP factory supply
• Custom impurity profile control
• Industry-serving since 2006
• COA, MSDS, DMF support
• Stable production capacity for long-term projects

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7. Frequently Asked Questions (FAQ)

Q1: What purity grade is recommended for oncology injectable formulations?

Most manufacturers use ≥99% HPLC with impurity control aligned to ICH Q3A/B.

Q2: Can you provide DMF or CTD documentation?

Yes. Zhonghong provides DMF/CTD files, stability data, and regulatory support.

Q3: What is the standard packaging?

• 1g / 5g / 10g sterile-grade packaging
• Nitrogen-filled, light-protected containers

Q4: Do you provide free samples for R&D?

Yes — small-batch samples available for formulation testing.

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8. Summary (Executive Highlights)

• Docetaxel remains a critical oncology API for injectables and advanced formulations.
• Manufacturers need high-purity, low-impurity, GMP-compliant Docetaxel.
• Docetaxel is used in polysorbate formulations, nanoparticles, liposomes, and combination therapies.
• Quality of API determines stability, safety, and final injection performance.
• Shaanxi Zhonghong (aiherba.com) provides custom specs, DMF documents, GMP batches, and strong technical support.

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9. References (PubMed / FDA / NIH)

1. FDA. Taxotere (Docetaxel) Label Information.
2. PubMed: Docetaxel pharmacology — https://pubmed.ncbi.nlm.nih.gov/
3. NIH: Chemotherapy Taxanes overview — https://www.nih.gov/
4. ICH Guidelines Q3A/Q3B/Q7
5. EMA Docetaxel formulation assessment reports