Do you provide GMP documentation for Paclitaxel?

Yes. AIHerba supplies full GMP documentation including COA, MSDS, process flow, stability study, impurity profile, and batch records for Paclitaxel API.

Can I buy small R&D quantities of Paclitaxel?

Yes. We offer low MOQ: 10 g for R&D and 100 g for commercial manufacturing. Free samples (<50 mg) are available for laboratory evaluation.

Do you offer customized formulations or OEM/ODM services?

Yes. As a GMP-certified manufacturer, AIHerba provides customized formulation support for oncology R&D and can produce tailored solutions for CRO/CMO needs.

Is Paclitaxel suitable for food or cosmetic applications?

No. Paclitaxel is strictly a pharmaceutical active ingredient used for oncology drug development and is not permitted for food or cosmetic use.

What industries commonly use AIHerba Paclitaxel?

Our Paclitaxel API is used by pharmaceutical companies, biotechnology institutes, CRO/CMO organizations, universities, and oncology R&D labs for clinical and preclinical studies.

Life Science & Pharmaceutical Ingredients

Paclitaxel

High-Quality Paclitaxel Powder – GMP Factory Supply for Injectable & Oral Dosage R&D

English Name: Paclitaxel

Specification

Pharmaceutical Grade: Paclitaxel ≥ 99% (HPLC), related substances ≤ 1%

Particle Size: Micronized powder ≤10 μm for better intravenous dispersion

Solubility: Poorly soluble in water; formulated as a Cremophor EL/ethanol solution (e.g., Taxol®) or in albumin – bound nanoparticles (Abraxane®) for enhanced solubility

Appearance

Powder: White to off – white crystalline powder, odorless

CAS NO.：33069-62-4

Lead time: 7 – 14 Working Days

Package

50 mg/vial (sterile glass vial), 10 vials/box; stored under nitrogen to prevent oxidation

Main Market: Global pharmaceutical market, especially in North America, Europe, and Asia

Application Scenarios

Core Properties

Molecular Formula: C₄₇H₅₁NO₁₄

Mechanism of Action:

Stabilizes microtubules by binding to β – tubulin, preventing their depolymerization and disrupting mitotic spindle function during cell division

Key Features

Potent Antitumor Activity: Effective against a wide range of cancers, including ovarian, breast, lung, and pancreatic cancer

Low Bioavailability: Oral absorption is negligible, requiring intravenous administration

High Specificity: Targets rapidly dividing cancer cells while sparing most normal cells

Application Scenarios

1. Oncology Treatment

First – line Therapy

Ovarian Cancer: Administered at 135 – 175 mg/m² every 3 weeks in combination with carboplatin, improving progression – free survival rates

Breast Cancer: Used at 175 mg/m² every 3 weeks or 80 mg/m² weekly, often in combination with trastuzumab for HER2 – positive tumors

Second – line and Salvage Therapy

Lung Cancer: Effective against non – small cell lung cancer (NSCLC), administered at 135 – 175 mg/m² in combination with cisplatin

Pancreatic Cancer: In combination with gemcitabine, paclitaxel (nab – paclitaxel) improves overall survival in patients with metastatic pancreatic cancer

2. Clinical Research

Combination Therapies:

Investigated in combination with immunotherapies (e.g., checkpoint inhibitors) to enhance antitumor immune responses

New Formulations:

Development of novel delivery systems (e.g., liposomal, polymer – conjugated paclitaxel) to reduce toxicity and improve efficacy

3. Veterinary Oncology

Canine and Feline Cancers:

Used in dogs and cats with mammary gland tumors, lymphoma, and osteosarcoma at adjusted dosages based on body surface area

Detection Methods

High – Performance Liquid Chromatography (HPLC):

Column: C18 (250 × 4.6 mm, 5 μm), Mobile Phase: Acetonitrile – water – triethylamine – phosphoric acid (230:270:1:0.8, v/v/v/v), Flow Rate: 1.0 mL/min, Detection Wavelength: 227 nm

Mass Spectrometry (MS):

Used for confirmation of molecular structure and detection of trace impurities in high – purity paclitaxel

Karl Fischer Titration:

Measures water content to ensure product stability and sterility

Source & Advantages

Natural Source: Initially isolated from the bark of the Pacific yew tree (Taxus brevifolia), now mainly produced through semi – synthesis from precursors in Taxus cell cultures or needles

Therapeutic Efficacy: One of the most widely used chemotherapy drugs globally, with a proven track record in improving cancer patient outcomes

Research Potential: Continues to be a key molecule in the development of new cancer treatment strategies

Regulatory Compliance

US FDA: Approved for multiple cancer indications, subject to strict Good Manufacturing Practice (GMP) regulations

EMA (European Medicines Agency): Licensed for use in oncology, with ongoing pharmacovigilance monitoring

China NMPA: Registered for clinical use in cancer treatment, requiring compliance with national pharmaceutical standards

Category: Life Science & Pharmaceutical Ingredients

描述

Paclitaxel Bulk API: High-Purity Anticancer Ingredient for Pharmaceutical Formulations

1. What Is Paclitaxel? (Overview & Origin)

Paclitaxel—commonly known by the brand name Taxol®—is a naturally derived anticancer compound originally isolated from the bark of Taxus brevifolia (Pacific yew). Today, high-quality pharmaceutical manufacturers rely on semi-synthetic sources and advanced extraction technology to obtain Paclitaxel at consistent purity levels suitable for oncology formulations.

At AIHerba® (Shaanxi Zhonghong Investment Technology Co., Ltd.), we supply GMP-certified Paclitaxel API designed for injectable solutions, liposomal formulations, microspheres, solvent-free delivery systems, and advanced oncology R&D. With over 28 years of extraction and purification experience, our factory specializes in bulk natural actives for global pharmaceutical companies, research institutions, and oncology product developers.

2. Why Paclitaxel Matters (Mechanism & Health Benefits)

2.1 Mechanism of Action

Paclitaxel stabilizes microtubules and prevents cell division, leading to apoptosis in rapidly proliferating cancer cells. Its broad-spectrum antitumor activity is supported by decades of clinical data.

2.2 Primary Therapeutic Benefits

Breast Cancer Treatment – First-line therapy for metastatic breast cancer and adjuvant regimens.
Ovarian Cancer – Standard of care in combination with platinum-based drugs.
Non–Small Cell Lung Cancer (NSCLC) – Widely used as part of multi-drug chemotherapy.
Kaposi’s Sarcoma – Effective at lower doses in immunocompromised patients.
Broader Oncology Applications – Under active investigation for bladder, gastric, and esophageal cancers.

2.3 Supporting Evidence

NIH & PubMed research highlight Paclitaxel’s microtubule-stabilizing action and clinical success in multiple cancers (PMID: 8780475; 7523089).
FDA-approved for various oncology indications (FDA Paclitaxel Label).
Long-term safety and efficacy documented in global oncology guidelines.

3. Applications Across Industries

Although Paclitaxel is primarily an oncology API, downstream sectors also use it for R&D:

3.1 Pharmaceutical & Medical

Injectable chemotherapy formulations
Liposomal Paclitaxel
Nanoparticle drug delivery (albumin-bound, polymeric nanoparticles)
Lyophilized powder for reconstitution
Sustained-release microspheres

3.2 Research & Biotech

Cell line studies
Tumor model development
Drug-resistance testing

3.3 Healthcare Manufacturing

Oncology pipeline development
Clinical trial formulations

(Paclitaxel is not used in cosmetics or food. AIHerba provides other GMP certified plant extract for cosmetics—see product list.)

4. Recommended Usage & Formulation Guide

4.1 Dosage Range (for pharmaceutical R&D reference only)

Conventional IV: 135–175 mg/m²
Weekly Regimens: 80–100 mg/m²
Albumin-bound (nab-Paclitaxel): 100–260 mg/m²

Note: Dosage must follow regional regulatory guidelines. Not for consumer use.

4.2 Formulation Compatibility

Soluble in ethanol, Cremophor® EL, DMSO
Compatible with liposomes and nanoparticle systems
Sensitive to oxidation—formulation antioxidants recommended

4.3 Best Formulation Practices

Use nitrogen-protected environment
Maintain low moisture & temperature during blending
Utilize sealed stainless-steel reactors for solvent processing

5. Production Technology & Manufacturing Workflow

5.1 Extraction & Purification

AIHerba® applies a hybrid process integrating:

Plant extraction (Taxus species needles & twigs)
Semi-synthesis pathways using 10-DAB from Taxus chinensis
Chromatographic purification to reach pharmaceutical-grade purity
Crystallization for final refinement

5.2 Standard Production Flowchart

Raw plant material selection →
10-DAB extraction →
Side-chain synthesis →
Semi-synthesis of Paclitaxel →
Multi-step purification (HPLC & column purification) →
Crystallization →
Drying →
Milling & sieving →
Sterile packaging →
Final QC & COA issuance

6. COA-Style Specification Sheet (Pharma-Grade)

6.1 General Specifications

Item	Specification	Method
Appearance	White to off-white crystalline powder	Visual
Assay (Paclitaxel)	≥ 99.0%	HPLC
Identification	Conforms	HPLC/IR
Solubility	Soluble in ethanol, DMSO	USP
Melting Point	213–216°C	USP

6.2 Pesticide Residue Testing

Pesticide	Limit	Method
Total organochlorines	≤ 0.1 ppm	GC-MS
Total organophosphates	≤ 0.1 ppm	GC-MS
Carbamates	≤ 0.05 ppm	LC-MS
Pyrethroids	≤ 0.1 ppm	GC-MS

6.3 Heavy Metals

Heavy Metal	Limit	Method
Lead (Pb)	≤ 1 ppm	ICP-MS
Arsenic (As)	≤ 1 ppm	ICP-MS
Cadmium (Cd)	≤ 0.5 ppm	ICP-MS
Mercury (Hg)	≤ 0.1 ppm	ICP-MS
Total Heavy Metals	≤ 10 ppm	USP<231>

6.4 Microbiological Tests

Parameter	Limit	Method
Total Plate Count	≤ 1,000 CFU/g	USP
Yeast & Mold	≤ 100 CFU/g	USP
E. coli	Negative	USP
Salmonella	Negative	USP
Staphylococcus aureus	Negative	USP
Pseudomonas aeruginosa	Negative	USP

7. Packaging, Storage & Shelf Life

7.1 Packaging

1 g / 5 g / 10 g sterile glass vial
100 g / 500 g / 1 kg aluminum foil bag (double layer)
Custom packaging available for customized herbal extract and oncology APIs

7.2 Storage

Keep sealed
Protect from light
Store at 2–8°C
Avoid humidity

7.3 Shelf Life

36 months under recommended storage.

8. MOQ, Lead Time, Shipping & Sample Policy

MOQ: 10 g (research grade) / 100 g (commercial)
Lead Time: 3–7 days for inventory; 2–4 weeks for production lots
Shipping: FedEx / DHL / air freight / temperature-controlled cargo
Free Sample: Yes, ≤ 50 mg (free sample herbal extract / API for R&D)

9. Why Choose AIHerba® as Your Paclitaxel Supplier?

9.1 Experience

28+ years in pharmaceutical extraction, oncology APIs, and GMP-compliant production.

9.2 Authority

GMP-certified
ISO9001 / ISO22000
Third-party testing (SGS, Eurofins)
Full documentation: COA, MSDS, TDS, stability data

9.3 Trust

Transparent supply chain
Traceable raw materials
In-house R&D team
Long-term partnerships with global pharmaceutical manufacturers

9.4 Factory Capability

Our manufacturer specializes in bulk oncology actives with scalable output and validated purification technology. Competitive price, full QC system, and customizable packaging.

10. Customer Use Cases

Oncology formulation developers using Paclitaxel in liposomal R&D
Pharmaceutical companies preparing investigational drug batches
Universities conducting cancer biology research
CROs/CMOs requiring small-scale API supply

11. FAQs (Professional Buyer Version)

1) Do you provide GMP documentation?

Yes. Full GMP set: COA, MSDS, process flow, stability data, impurity profile.

2) Can I buy small R&D quantities?

Yes—MOQ starts from 10 g.

3) Do you offer OEM/ODM formulation support?

Yes. As a dietary supplement raw material manufacturer and oncology extract specialist, we provide custom formulation guidance.

4) Can Paclitaxel be supplied in bulk for large production?

Yes. We support kilograms-level shipments.

5) Is Paclitaxel suitable for food/cosmetics?

No. It is strictly a pharmaceutical API.

12. References (PubMed, NIH, FDA)

Rowinsky EK, Donehower RC. Paclitaxel pharmacology. J Natl Cancer Inst. PMID: 7523089
Schiff PB et al. Microtubule stabilization mechanism. Nature. PMID: 8780475
FDA Paclitaxel Injection Drug Label
NIH MedlinePlus Drug Information: Paclitaxel

13. Contact & Verification

AIHerba® | Shaanxi Zhonghong Investment Technology Co., Ltd.
📧 sales@aiherba.com | info@aiherba.com | liaodaohai@gmail.com
🌐 www.aiherba.com
GMP-Certified Plant Extract & Oncology API manufacturer, supplier, and factory.