Vincristine Sulfate Pharmaceutical Raw Material – Trusted Supplier for Injectable Formulations
1. Product Overview
Vincristine (Vincristine Sulfate) is a chemotherapy active pharmaceutical ingredient (API) derived from Catharanthus roseus (Madagascar periwinkle). It is widely used in oncology formulations, including injectables for leukemia, lymphoma, and solid tumors.
At AIHerba® (Shaanxi Zhonghong Investment Technology Co., Ltd.), we supply pharmaceutical-grade Vincristine with traceable raw materials, validated processes, ICH-Q7 manufacturing, and complete quality documentation.
As a GMP-certified manufacturer, we support global buyers needing bulk Vincristine, wholesale supply, and customized specifications, including purified fractions for R&D or formulation development.
2. Product Origin & Manufacturing Expertise
Vincristine is extracted from Catharanthus roseus using a controlled multi-step process that involves:
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Plant alkaloid extraction
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Fractional purification
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Selective separation of vincristine from vinca alkaloids
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Conversion to Vincristine Sulfate (API form)
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Final crystallization and pharmaceutical-grade refinement
Our factory has over 28 years of extraction and purification experience, with dedicated oncology-grade cleanrooms and validated chromatography systems.
3. Key Benefits & Functional Properties
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Clinically validated antineoplastic activity
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Interferes with microtubule formation to block cancer cell mitosis.
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Widely referenced in global treatment guidelines (NCCN, WHO).
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Preferred in combination chemotherapy
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Used in R-CHOP, MOPP, and other cornerstone oncology regimens.
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High potency at low doses
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Requires exceptional purity and controlled particle size (supplied).
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Regulatory-ready documentation
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COA, MSDS, stability data, impurity profile, microbial limits, residual solvent report.
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Suitable for
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Injectable preparations
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Oncology drug development
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Academic or hospital research
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Contract manufacturing (CMO/CRO)
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4. Modern Use Cases & Application Scenarios
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Pharmaceutical manufacturers producing oncology injectables
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R&D laboratories conducting antitumor mechanism studies
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Hospitals / cancer institutes for clinical formulation trials
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CRO/CMO partners requiring GMP-grade Vincristine for scale-up
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Dietary supplement raw material manufacturer collaboration (non-pharma research only)
5. Traditional Applications (Historical Background)
Before its pharmaceutical isolation, Catharanthus roseus was used in folk medicine across India and the Caribbean for managing infections and metabolic disorders. The discovery of vinca alkaloids in the 1950s led to the development of modern chemotherapeutics, of which Vincristine became one of the most impactful.
6. Recommended Dosage (For Manufacturers Only)
Note: For formulation R&D and professional use only — not consumer advice.
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Parenteral dosage (common ranges): typically 1.4 mg/m² (adult), not exceeding 2 mg per dose.
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Final dosage must follow USP, FDA labeling, and clinical protocol guidance.
7. Specification Sheet & COA Summary
7.1 General Specifications
| Parameter | Standard |
|---|---|
| Appearance | White to off-white crystalline powder |
| Purity (HPLC) | ≥ 98.0% |
| Identification | Meets USP/EP |
| Residual Solvents | Within ICH Q3C limits |
| Water Content | ≤ 5.0% (Karl Fischer) |
| Specific Rotation | Within USP limits |
| Assay | 98–102% |
7.2 Pesticide Residue Testing (Examples)
(All parameters meet EU, USP, and WHO guideline limits)
| Item | Limit | Method |
|---|---|---|
| Organochlorine pesticides | ≤ 0.1 ppm | GC-MS |
| Organophosphorus pesticides | ≤ 0.5 ppm | LC-MS/MS |
| Pyrethroid pesticides | ≤ 0.2 ppm | GC-MS |
| Carbamate pesticides | ≤ 0.5 ppm | LC-MS |
7.3 Heavy Metal Testing
| Item | Limit | Method |
|---|---|---|
| Lead (Pb) | ≤ 1.0 ppm | ICP-MS |
| Arsenic (As) | ≤ 1.0 ppm | ICP-MS |
| Cadmium (Cd) | ≤ 0.5 ppm | ICP-MS |
| Mercury (Hg) | ≤ 0.1 ppm | ICP-MS |
| Total Heavy Metals | ≤ 10 ppm | USP <231> |
7.4 Microbiological Testing
| Item | Limit | Method |
|---|---|---|
| Total Plate Count | ≤ 1,000 cfu/g | USP <61> |
| Yeast & Mold | ≤ 100 cfu/g | USP <61> |
| E. coli | Negative | USP <62> |
| Salmonella | Negative | USP <62> |
| Staphylococcus aureus | Negative | USP <62> |
8. Production Process (Text + Infographic Layout)
Production Flowchart (Narrative)
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Raw Material Collection – Fresh Catharanthus roseus verified and quarantined.
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Solvent Extraction – Alkaloids extracted via water-ethanol extraction.
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Purification – Chromatographic separation of vinca alkaloids.
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Selective Isolation – Isolation and enrichment of Vincristine.
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Sulfate Conversion – Controlled sulfation to produce Vincristine Sulfate API.
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Crystallization & Drying – Vacuum drying under inert atmosphere.
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Milling & Sieving – Particle size controlled for injectables.
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QC Testing – Full-spectrum analysis (HPLC, LC-MS, ICP-MS, GC-MS).
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Packaging – Sterile dual-layer pharmaceutical packaging.
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Final Release – QA review, COA issuance, batch traceability.
9. Storage & Shelf Life
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Storage: 2–8°C, protected from light and moisture
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Shelf Life: 24–36 months (sealed, tested)
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Packaging:
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1 g / 5 g / 10 g sterile bottles
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Custom packaging available for CRO/CMO customers
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10. MOQ, Sample Policy & Shipping
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MOQ: 1 g (R&D grade); 10 g–100 g (commercial scale)
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Free Sample: Available for qualified buyers (free sample herbal extract / oncology API request)
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Lead Time: 3–7 days for stock; 2–3 weeks for customized herbal extract specifications
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Shipping: International express (DHL/FedEx), air cargo, or temperature-controlled shipment
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Price: Depends on purity, quantity, regulatory documentation, and contract terms
11. Applicable Industries
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Pharmaceutical manufacturers
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Oncology formulation plants
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CRO/CMO facilities
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Academic and hospital research labs
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Biotechnology companies
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Diagnostic reagent developers
12. How to Use (For Industry Only)
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Dissolve Vincristine Sulfate in sterile water for injectable formulation
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Maintain aseptic conditions under GMP guidelines
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Conduct full impurity, sterility, and endotoxin testing prior to release
(Not intended for consumer use.)
13. Certifications & Quality Assurance
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GMP Certified Factory (ICH-Q7)
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ISO9001 / ISO22000
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Full COA, MSDS, TDS, HPLC chromatogram
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Batch traceability system
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Third-party testing available (SGS, Eurofins)
14. Why Work With AIHerba®
Professionalism (Expertise)
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28+ years of experience in alkaloid extraction & chromatographic purification
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Advanced supercritical CO₂ systems and pharmaceutical-grade clean areas
Authority
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Documentation aligned with USP, EP, ICH, FDA guidelines
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Peer-reviewed references supporting Vincristine’s efficacy
Trust
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Transparent pricing, COAs, real batch data, and photo documentation
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Direct manufacturer — no brokers, no diluted supply chain
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Verified contact: sales@aiherba.com | info@aiherba.com | liaodaohai@gmail.com
15. Frequently Asked Questions (FAQ)
1. Can I buy Vincristine in bulk for pharmaceutical production?
Yes — we are a GMP pharmaceutical supplier providing bulk Vincristine for global manufacturers.
2. Do you provide a full COA and impurity profile?
Yes, each batch includes HPLC assay, impurities, microbial limits, heavy metals, and solvents.
3. Are customized specifications available?
Yes — we support customized herbal extract–derived alkaloid purification and special particle-size needs.
4. What is your lead time?
3–7 days for stock lots; custom orders require 2–3 weeks.
5. Can you support registration dossiers (DMF/CEP)?
Regulatory documentation support is available for qualified partners.
16. References (PubMed / FDA / NIH)
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NIH / NCI Cancer Drug Information: Vincristine
https://www.cancer.gov/about-cancer/treatment/drugs/vincristine -
PubMed – Vincristine Clinical Studies
https://pubmed.ncbi.nlm.nih.gov/ -
FDA Label Information – Vincristine
https://www.accessdata.fda.gov/drugsatfda_docs/
