Paclitaxel API CAS 33069-62-4
Paclitaxel API CAS 33069-62-4
Paclitaxel API,CAS 33069-62-4,semi-synthetic paclitaxel,bulk Taxol raw material,oncology API manufacturer,10-DAB precursor,GMP paclitaxel factory,Shaanxi Sunrise
Source high-purity Paclitaxel API (CAS 33069-62-4) from Shaanxi Sunrise. Semi-synthetic, ≥99% HPLC purity. Supported with full DMF/GMP documentation for oncology formulation R&D and commercial manufacturing.
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Description
PREMIUM ACTIVE PHARMACEUTICAL INGREDIENT (API)
Paclitaxel
CAS No.: 33069-62-4
Assay / Purity≥99.0% (HPLC)
Molecular FormulaC47H51NO14
Molecular Weight853.91 g/mol
SourceSemi-synthetic
Scientific Overview & Manufacturing Excellence
Our company specializes in the independent research, development, and large-scale manufacturing of high-purity Paclitaxel active pharmaceutical ingredients (APIs). Utilizing a sophisticated semi-synthetic approach, we implement advanced and strictly controllable purification processes to ensure that the active ingredient content consistently exceeds 99.0% (via HPLC methodology).
This product is manufactured in rigorous compliance with GMP guidelines, supported by a comprehensive quality management system. From starting materials to finished goods, we conduct end-to-end quality control to guarantee minimal batch-to-batch variation, a clearly defined impurity profile, and full compliance with the stringent standards of the Chinese Pharmacopoeia (ChP), as well as European and US Pharmacopoeias (EP/USP).
Pharmacological Profile & Formulation Applications
Mechanism of Action (MoA)
At the cellular level, Paclitaxel functions as a potent microtubule-stabilizing agent. It actively promotes tubulin polymerization while simultaneously inhibiting its depolymerization. This critical interference in cancer cell mitosis effectively arrests the cell cycle, ultimately inducing targeted apoptosis.
API Formulation Targets
As a high-grade raw material, Paclitaxel is extensively utilized by pharmaceutical institutions worldwide in the research and commercial formulation of advanced therapeutics targeting various solid tumors. Primary formulation targets include ovarian cancer, breast cancer, non-small cell lung cancer, pancreatic cancer, esophageal cancer, and cervical cancer.
Clinical Pharmacology Notes
Important considerations for formulators and researchers: The associated clinical profile of formulations utilizing this API may include phenomena such as hair loss, bone marrow suppression (leading to decreased immunity), limb numbness, allergic reactions, myalgia (muscle pain), and gastrointestinal effects like diarrhea.
Technical Specifications & Logistics
| Product Identity | Paclitaxel (Semi-synthetic API) |
|---|---|
| Characteristics / Appearance | White to off-white crystalline powder |
| Test Method & Purity | HPLC Analysis; Assay ≥ 99.0% |
| Packaging Configurations | • R&D Scale: 1g - 100g per bottle • Pilot Scale: 1kg per specialized aluminum foil bag • Commercial Bulk: 25kg per fiber drum |
| Storage Conditions | Keep the container tightly closed. Requires a light-proof environment at 2-8°C refrigerated storage. Maintain strict dryness to preserve chemical stability. |
| Shelf Life | 24 months (under optimal storage conditions) |
Frequently Asked Questions (Regulatory & Procurement)
What is the synthetic route and botanical source of your Paclitaxel API?
Our Paclitaxel API is semi-synthetic. It is synthesized from sustainable precursors (such as 10-Deacetylbaccatin III, or 10-DAB III) naturally extracted from renewable Taxus species. This advanced route ensures high manufacturing yield, environmental sustainability, and a highly controllable impurity profile compared to direct botanical extraction.
Do you provide complete regulatory documentation like DMF and GMP certificates?
Yes, absolutely. We fully support international regulatory filings. We can provide complete technical packages including Open Part DMF (Drug Master File), GMP compliance certificates, accelerated and long-term stability study data, as well as detailed residual solvent and heavy metal testing reports upon request.
How do you control critical related substances and impurities (e.g., Cephalomannine)?
Through our proprietary multi-stage chromatographic purification technology, we rigorously control critical related substances. Impurities such as Cephalomannine, 10-DAB III, and Baccatin III are strictly monitored and maintained well below the limits specified by the latest USP and EP monographs.
What is the Minimum Order Quantity (MOQ) for clinical R&D versus commercial manufacturing?
We offer highly flexible supply tiers to support the entire drug lifecycle. For R&D formulation and clinical trials, we support MOQs starting from 1g to 100g packaged in sealed amber vials. For commercial-scale manufacturing, we supply bulk quantities in 1kg foil bags and robust 25kg fiber drums.