Botanical Essence is a trusted global manufacturer and supplier of high-purity Vincristine Sulfate, delivering consistent quality for pharmaceutical manufacturers, oncology formulation developers, and international distributors.
Introduction to Vincristine Sulfate
Vincristine Sulfate is a naturally derived vinca alkaloid that functions as a potent mitotic inhibitor. It has been a cornerstone in modern chemotherapy protocols for decades and remains one of the most important plant-based anticancer agents used in clinical oncology worldwide.
The mechanism of action is well understood: Vincristine binds specifically to tubulin dimers, inhibiting their polymerization into microtubules. This disruption prevents the formation of the mitotic spindle, arresting cell division at metaphase and ultimately triggering apoptosis in rapidly proliferating cells, particularly malignant ones. Because cancer cells divide more frequently than normal cells, Vincristine exerts selective cytotoxicity against tumors while still requiring careful clinical management.
Key Therapeutic Applications
As a critical active pharmaceutical ingredient (API), Vincristine Sulfate is primarily used in the treatment of:
- Hodgkin’s lymphoma and Non-Hodgkin’s lymphoma
- Acute lymphoblastic leukemia (ALL)
- Wilms’ tumor (nephroblastoma)
- Pediatric leukemias
- Advanced solid tumors and palliative care regimens
Its proven efficacy in combination chemotherapy protocols makes it a preferred choice for both branded oncology formulations and generic injectable preparations.
Product Specifications
Product Name: Vincristine Sulfate
CAS No.: 2068-78-2
Molecular Formula: C₄₆H₅₆N₄O₁₀·H₂SO₄
Appearance: White or almost white crystalline powder
| Items | Specifications | Results |
|---|---|---|
| Character | White or almost white crystalline powder | White crystalline |
| Identification (IR) | Should meet the requirements | Complies |
| Sulfate Discrimination | Should meet the requirements | Complies |
| pH (1% solution) | 3.5–4.5 | 4.0 |
| Solubility | Soluble in water | Complies |
| Loss on Drying | NMT 12.0% | 6.3% |
| Sterility & Bacterial Endotoxins | Should meet the requirements | Complies |
| Related Substances | Individual impurities NMT 1.0% | |
| Total impurities NMT 4.0% | 0.48% | |
| 2.0% | ||
| Assay (anhydrous basis) | 95.0%–105.0% (C₄₆H₅₆N₄O₁₀·H₂SO₄) | 99.99% |
Production & Quality Assurance
At Botanical Essence, Vincristine Sulfate is produced under strict cGMP conditions with full traceability from raw Catharanthus roseus (Madagascar periwinkle) plant material. Our advanced extraction and purification technology ensures exceptionally high purity and batch-to-batch consistency.
Every batch undergoes comprehensive testing including HPLC, infrared spectroscopy, endotoxin testing, and impurity profiling. We maintain rigorous quality control systems aligned with USP, EP, and ICH guidelines, providing complete documentation including COA, MSDS, TSE/BSE statements, and stability data to support global regulatory filings and international trade requirements.
Physico-Chemical Properties & Formulation Advantages
- Excellent water solubility, facilitating easy preparation of injectable solutions
- Stable crystalline form suitable for long-term storage
- High assay value (typically ≥99.5%) minimizes dosage variability
- Low individual impurity levels ensure superior safety profile in final drug products
These characteristics make our Vincristine Sulfate particularly attractive for manufacturers developing lyophilized powders, ready-to-use injections, and complex multi-drug oncology combinations.
Why Choose Botanical Essence as Your Vincristine Supplier?
Pharmaceutical companies, contract manufacturing organizations (CMOs), and specialty distributors worldwide select Botanical Essence because we offer:
- Pharmaceutical-grade purity with consistent ≥99.5% assay
- Reliable supply chain and long-term capacity assurance
- Comprehensive regulatory documentation and audit-ready quality systems
- Technical support for formulation development and stability studies
- Competitive pricing with flexible order quantities
Whether you are developing generic oncology injectables, researching novel drug delivery systems, or expanding your anticancer product portfolio, our Vincristine Sulfate delivers the purity, reliability, and documentation required for successful market authorization and commercial scale-up.
For samples, specifications, quotation, or technical discussion, please contact our specialist team at [email protected].
Botanical Essence – Your trusted partner in high-purity botanical APIs and pharmaceutical raw materials.
