2.Specification:98%
3.CAS:33069-62-4
4.Free Sample
5.Capsules,tablets,softgel,gummies,small bags,private label
6.Test Method:HPL,UV&GC
7.Vacuum Aluminum Foil Bag; Fiber Drum for 25kg with inside double layer food grade poly bag
8.DeliveryTime:1-3 working days
Organic,Gluten free,no Allergen,Non-GMO,Paraben free,No Colors, BSE/TESE Free,Vegan
- Product Description
Taxol Powder Manufacturer and Supplier
As a leading Taxol Powder manufacturer and supplier, Shaanxi Fairir Biotech Co., Ltd. offers premium-grade paclitaxel for pharmaceutical applications. Our state-of-the-art extraction technologies and rigorous quality control ensure the highest purity and potency of our product. With GMP certification and advanced R&D capabilities, we deliver reliable, cost-effective solutions for oncology drug development and production.
What is Taxol Powder?
The product, also known as paclitaxel, is a potent chemotherapy medication derived from the bark of Pacific yew trees. It's widely used in treating various cancers, including ovarian, breast, and lung cancer. Our high-quality Taxol extract maintains optimal bioactivity for maximum therapeutic efficacy.
Why Choose Us?
- GMP-certified 10,000㎡ production facility
- Comprehensive quality management system (ISO 9001, ISO 22000, HACCP)
- Experienced R&D team with 11 master's degree holders
- Cutting-edge analytical equipment for precise quality control
COA (Certificate of Analysis)
TEST |
TEST METHOD |
SPECIFICATIONS |
RESULT |
|
ASSAY (calculated on the anhydrous, solvent-free basis) |
USP<621> |
97.0%~102.0% |
100.40% |
|
Appearance |
USP<621> |
White or almost white crystalline powder. |
White crystalline powder |
|
SPECIFIC ROTATION |
USP<781S> Method Ic |
-49.0°~-55.0° |
-52.1° |
|
IDENTIFICATION |
IR USP<197K> |
Infrared Absorption:In accordance with the reference Standard spectrum of paclitaxel |
Conforms |
|
HPLC USP<621> |
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay. |
Conforms |
||
(HPLC) RELATED COMPOUNDS
|
10-Deacetylbaccatin Ⅲ |
USP<621>Test
|
NMT 0.1% |
Undetected |
Baccatin III |
NMT 0.2% |
Undetected |
||
Photodegradant |
NMT 0.1% |
Undetected |
||
10-Deacetylpaclitaxel |
NMT 0.5% |
Undetected |
||
2-Debenzoylpaclitaxel-2-pentenoate |
NMT 0.1% |
0.03% |
||
Oxetane ring opened, acetyl and benzoyl migrated |
NMT 0.4%
|
Undetected
|
||
10-Acetoacetylpaclitaxel |
||||
10-Deacetyl-7-epipaclitaxel |
||||
7-Epipaclitaxel |
NMT 0.4% |
≤0.03% |
||
10,13-Bissidechainpaclitaxel |
NMT 0.5% |
Undetected |
||
7-Acetylpaclitaxel |
NMT 0.6% |
Undetected |
||
13-Tes-baccatin III |
NMT 0.1% |
Undetected |
||
7-Tes-paclitaxel |
NMT 0.3% |
Undetected |
||
Others |
NMT 0.1% (each) |
0.03% |
||
Total |
NMT 2.0% |
0.14% |
||
ORGANIC VOLATILE IMPURITIE
|
Acetone |
|
NMT 5000ppm |
26ppm |
n-heptane |
|
NMT 5000ppm |
2102ppm |
|
Dichloromethane |
|
NMT 600ppm |
Undetected | |
Ethanol |
|
NMT 5000ppm |
20ppm |
|
WATER |
USP <921> Method Ic |
NMT 2.0% |
0.66% |
|
RESIDUE ON IGNITION |
USP<281> |
NMT 0.2% |
0.05% |
|
HEAVY METALS |
USP<231>Method Ⅱ |
NMT 0.001% |
Conforms |
|
BACTERIAL ENDOTOXINS |
USP<85> |
NMT 0.4 EU/mg |
Conforms |
|
MICROBIAL LIMITS |
USP<61> |
Total aerobic microbial count NMT100 cfu/g |
10 cfu/g |
|
|
|
It meets the requirements of the tests for the absence of Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella species, and Escherichia coli |
Conforms |
|
CONCLUSION |
The product is in accordance with USP43to test the above-mentioned items, the test results conform to the specification. |
*Please contact us for the latest COA.
Taxol Powder Function
The product functions as a mitotic inhibitor, disrupting cancer cell division by stabilizing microtubules. This mechanism effectively halts tumor growth and promotes cancer cell death, making it a cornerstone in modern chemotherapy regimens.
Our Manufacturing Process
Our Taxol production adheres to stringent GMP standards, utilizing advanced extraction and purification techniques. Each batch undergoes rigorous quality testing using state-of-the-art HPLC and GC-MS analysis, ensuring consistent potency and safety for pharmaceutical applications.
Benefits for Global Buyers
- Guaranteed purity (>99%) meeting USP/EP standards
- Flexible MOQs to accommodate varying production scales
- Comprehensive regulatory documentation for smooth approval processes
- Stable supply chain with consistent batch-to-batch quality
- Competitive pricing for bulk orders without compromising quality
- Expert technical support for formulation and regulatory queries
- Fast turnaround times and reliable global shipping
- Eco-friendly extraction methods aligning with sustainability goals
- Custom synthesis options for specialized research needs
- Full traceability from raw material to finished product
Taxol Powder Applications
Taxol Powder finds extensive use in oncology, primarily in formulating injectable solutions for chemotherapy. It's crucial in treating advanced ovarian cancer, metastatic breast cancer, and non-small cell lung cancer. Emerging applications include nanoparticle-based drug delivery systems and combination therapies, showcasing its versatility in modern cancer treatment protocols.
Quality Assurance
Our quality control lab employs 5 liquid chromatographs, 2 gas chromatographs, and advanced spectrometry tools to ensure each batch meets the highest standards. We adhere to cGMP, USP, and EP guidelines, providing comprehensive COAs for every shipment.
Certification
- GMP (cGMP)
- ISO 9001:2015
- ISO 22000
- HACCP
- FSSC 22000
- Kosher
- Halal
OEM/ODM Services
We offer tailored OEM/ODM services, including custom synthesis, formulation development, and specialized packaging solutions to meet your specific requirements.
Packaging and Delivery
- Standard packaging: 1kg aluminum foil bags in fiber drums
- Custom packaging available upon request
- Temperature-controlled shipping to maintain product integrity
- Express delivery options for urgent orders
FAQ
-
Q: What is the minimum order quantity (MOQ) for the product?
A: Our standard MOQ is 100g, but we can accommodate smaller quantities for research purposes.
-
Q: Do you provide stability data for your product?
A: Yes, we offer comprehensive stability data covering various storage conditions.
-
Q: Can you assist with regulatory filings?
A: Absolutely. Our regulatory team can provide necessary documentation to support your filings.
-
Q: What is the lead time for bulk product orders?
A: Typical lead time is 2-3 weeks, depending on order volume and current stock levels.
-
Q: Do you offer Taxol analogs or derivatives?
A: Yes, we can synthesize various Taxol analogs. Please contact us for specific requirements.
-
Q: Is your product suitable for clinical trials?
A: Yes, our product meets ICH guidelines for use in clinical studies.
Contact Us
For inquiries or to place an order, please contact our sales team:
Email: sales@fairirbiotech.com
Experience the Fairir Biotech difference in Taxol Powder supply. Let's advance cancer treatment together with our premium-quality paclitaxel.