Vinblastine
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Vinblastine

Vinblastine supplier bulk factory Wholesale buy Extract factory

  1. Nom anglais: Vinblastine
  1. Spécification
    • Pureté: Vinblastine sulfate ≥ 98% (HPLC); high – purity grade: ≥ 99% (HPLC)
    • Solubilité: Soluble in water (as sulfate salt, ~50 mg/mL), methanol, and ethanol; insoluble in non – polar solvents
    • Apparence – Connexes: Loss on drying ≤ 1.0%, heavy metals ≤ 10 ppm, residual solvents ≤ 0.5%
    • Taille des particules: Standard powder ≤ 100 μm; micronized powder ≤ 5 μm for better dissolution in formulations
  1. Apparence
    • White to off – white crystalline powder (sulfate salt form), odorless
  1. N° CAS：143-67-9 (Vinblastine); 2068 – 78 – 2 (Vinblastine sulfate)
  1. Délai de mise en œuvre: 7 à 10 jours ouvrables
  1. Emballer
    • 10 mg/vial (sterile glass vial), sealed under nitrogen; 100 mg/aluminum foil – lined bag for research – grade products
  1. Marché principal: Global pharmaceutical and research markets, with significant demand in North America, Europe, and Asia, mainly for oncology treatment and biomedical research
  1. Scénarios d'application

Propriétés de base

  • Formule moléculaire: C₄₆H₅₈N₄O₉ (Vinblastine); C₄₆H₅₈N₄O₉·2H₂SO₄ (Vinblastine sulfate)
  • Structure chimique: An indole – alkaloid derived from Catharanthus roseus (Madagascar periwinkle), consisting of a complex dimeric structure with two linked indole rings.
  • Caractéristiques principales
    • Antimitotic Agent: Binds to tubulin, inhibiting microtubule polymerization and disrupting the mitotic spindle during cell division, leading to cell cycle arrest at the metaphase – anaphase transition.
    • Broad – Spectrum Antitumor Activity: Effective against various cancers, including Hodgkin’s lymphoma, non – Hodgkin’s lymphoma, testicular cancer, breast cancer, and lung cancer.
    • Faible biodisponibilité: Oral absorption is poor; typically administered intravenously for therapeutic use.
    • Haute puissance: Requires careful dosage control due to significant toxicity to rapidly dividing normal cells (e.g., bone marrow, gastrointestinal tract).

Scénarios d'application

1. Oncology Treatment

  • Chemotherapy Regimens:
    • Hodgkin’s Lymphoma: A key component of the ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) regimen, achieving high remission rates (up to 80 – 90% in early – stage cases).
    • Testicular Cancer: Used in combination with cisplatin and bleomycin (PVB regimen), contributing to the high cure rate of testicular germ cell tumors.
    • Breast and Lung Cancer: Employed as a second – line or palliative treatment option, either alone or in combination with other chemotherapeutic agents.
  • Adjuvant Therapy:
    • Given after surgery or radiation to reduce the risk of cancer recurrence by targeting remaining cancer cells.

2. Recherche biomédicale

  • Études de biologie cellulaire:
    • Used as a tool to study microtubule dynamics, cell division mechanisms, and the role of the cytoskeleton in cell function. By disrupting microtubule formation, researchers can observe cellular responses to mitotic stress.
  • Développement de médicaments:
    • Serves as a reference compound for the development of novel antimitotic drugs. Its structure inspires the synthesis of analogs with improved efficacy, reduced toxicity, and enhanced selectivity for cancer cells.
  • Cancer Resistance Research:
    • Investigated to understand how cancer cells develop resistance to microtubule – targeting agents. This knowledge helps in designing strategies to overcome resistance, such as combination therapies or novel drug delivery systems.

3. Veterinary Oncology

  • Cancer Treatment in Animals:
    • Administered to dogs and cats with certain types of cancers (e.g., lymphoma, mast cell tumors) at adjusted dosages based on body weight and species – specific pharmacokinetics.

Méthodes de détection

  • Chromatographie liquide à haute performance (HPLC):
    • Column: C18 (250 × 4.6 mm, 5 μm), Mobile Phase: Acetonitrile – 0.1% trifluoroacetic acid (gradient elution), Flow Rate: 1.0 mL/min, Detection Wavelength: 262 nm for quantification.
  • Chromatographie liquide – Spectrométrie de masse (LC – MS):
    • Used for identifying vinblastine and its metabolites in biological samples, providing high – sensitivity detection and confirmation of the compound’s structure.
  • Spectroscopie UV-Visible:
    • Quick – screening method to estimate vinblastine concentration based on its characteristic absorption peak at 262 nm, useful for initial quality control and batch analysis.

Source et avantages

  • Source naturelle: Originally isolated from the leaves and stems of Catharanthus roseus. However, due to the low natural content (0.002 – 0.005% dry weight) and environmental considerations, semi – synthetic and synthetic production methods are increasingly used.
  • Importance thérapeutique: A cornerstone in cancer chemotherapy, having significantly improved survival rates for several types of cancer since its discovery.
  • Research Value: A fundamental tool in biological research, facilitating the understanding of basic cellular processes and driving innovation in cancer treatment strategies.

Conformité réglementaire

  • FDA américaine: Approved as an antineoplastic drug, strictly regulated under the Federal Food, Drug, and Cosmetic Act. Stringent manufacturing, labeling, and safety standards must be met for clinical use.
  • EMA (Agence européenne des médicaments): Licensed for use in oncology, with continuous pharmacovigilance to monitor adverse effects and ensure patient safety.
  • NMPA de Chine: Registered for clinical use in cancer treatment, subject to Good Manufacturing Practice (GMP) requirements and regular quality inspections.
Catégories: ,

Vinblastine Sulfate: The Vinca Alkaloid Powerhouse in Most cancers Therapeutics | Supplier & Manufacturer

1. What is Vinblastine?
Vinblastine sulfate is a dimeric indole-dihydroindole vinca alkaloid derived from the Madagascar periwinkle (Catharanthus roseus). As a potent microtubule-destabilizing agent, it binds to β-tubulin subunits on the vinca area, inhibiting microtubule meeting and suppressing mitotic spindle formation. This triggers Arrêt partiel G2/M et mitotic disaster in quickly proliferating cells. Acknowledged as an important drugs by WHO, it is clinically indispensable for treating Hodgkin lymphoma, testicular most cancers, and superior breast carcinoma.

2. Supply, Chemical Properties & Identifiers

  • Fournir: Remoted from leaves of Catharanthus roseus; semi-synthesis from precursors catharanthine and vindoline.

  • Propriétés chimiques :

    • Nom chimique : Methyl (3aR,4R,5S,5aR,10bR,13aR)-4-acetoxy-3a-ethyl-9-((5S,7R,9S)-5-ethyl-5-hydroxy-9-(methoxycarbonyl)-1,4,5,6,7,8,9,10-octahydro-2H-3,7-methanoazacycloundecino(5,4-b)indol-9-yl)-6-formyl-5-hydroxy-8-methoxy-3a,4,5,5a,6,11,12,13a-octahydro-1H-indolizino(8,1-cd)carbazole-5-carboxylate sulfate

    • Formulation moléculaire : C₄₆H₅₈N₄O₉ · H₂SO₄

    • Poids moléculaire : 909.06 g/mol

    • Apparence: White to off-white hygroscopic crystalline powder

    • Solubilité: Freely soluble in water, methanol; insoluble in ether

    • Stabilité: Mild-sensitive; oxidizes beneath alkaline situations

  • Identifiants clés :

    • CAS: 143-67-9 (vinblastine sulfate)

    • Quantité CE (EINECS) : 205-620-3

    • MF: C₄₆H₆₀N₄O₁₃S

    • MW: 909.06

3. Pharmaceutical-Grade High quality & Scientific Profile

  • Optimum Product: Requires >99.5% HPLC purity, <0.1% vincristine (poisonous isomer), and undetectable endotoxins (<0.25 EU/mg). Shaanxi Zhonghong ensures this by way of countercurrent chromatography et crystallization controls.

  • Therapeutic Purposes:

    • Oncologie: First-line for Hodgkin’s lymphoma (ABVD routine), NSGCT, choriocarcinoma, Kaposi sarcoma.

    • Mécanisme: Binds tubulin → depolymerizes microtubules → blocks metaphase → apoptosis.

    • (Be aware: Nattokinase reveals anticoagulant properties; no strong proof helps kidney-specific advantages)

  • Dosage:

    • Medical Use Solely: Administered IV (0.1-0.5 mg/kg weekly). No oral complement kind exists.

  • Vital Security Profile:

    • Hematologic: Extrême neutropenia (nadir Day 7-10), thrombocytopenia.

    • Neurotoxicity: Peripheral neuropathy (much less extreme than vincristine).

    • GI Results: Nausea, constipation, ileus.

    • Extravasation Hazard: Causes tissue necrosis; requires central line administration.

    • Contre-indications : Energetic infections, bone marrow suppression, being pregnant (FDA Class D).

4. Shaanxi Zhonghong: Pioneering Vinca Alkaloid Manufacturing
Avec 28+ years in plant-derived oncology APIs, we ship cGMP vinblastine sulfate assembly USP/EP monographs. Core strengths:

  • Scientific Infrastructure:

    • 5 Tutorial Joint Labs (Isolation chemistry, analytical improvement)

    • Patented Extraction Tech (CN202310XXXXXX: high-yield vindoline purification)

  • Supériorité analytique :

    • HPLC-ELSD/MS (purity)

    • UPLC-PDA (isomeric impurity management)

    • Superconducting 600MHz NMR (structural affirmation)

    • LAL Endotoxin Testing (<0.25 EU/mg)

  • World Provide: APIs shipped to Plus de 80 sites internationaux beneath cold-chain protocols.

5. Rigorous High quality Specs

Classe Paramètre Spécification Technique
Pesticides Dichlorvos ≤0.01 mg/kg GC-MS/MS (EU 2021/601)
Malathion ≤ 0,05 mg/kg GC-MS/MS
Métaux lourds Pb ≤1 ppm ICP-MS (USP <232>)
Comme ≤ 0,5 ppm ICP-MS
Microbiologie TAMC ≤10² CFU/g USP <61>
Bile-tolerant GNR Absent/10g USP <62>
Vital Attributes Vinblastine Sulfate ≥99.5% HPLC-ELSD (USP <621>)
Vincristine ≤0,1% UPLC-PDA
Teneur en eau ≤5.0% Karl Fischer
Endotoxins <0.25 EU/mg LAL (USP <85>)

6. cGMP Manufacturing Course of

  1. Biomass Cultivation: C. roseus grown beneath GACP-controlled situations.

  2. Alkaloid Extraction: pH-modulated solvent extraction (EtOAc/H₂O).

  3. Séparation chromatographique : Flash chromatography → HPLC purification (vindoline/catharanthine).

  4. Dimerization: Fe³⁺-catalyzed coupling of vindoline and catharanthine.

  5. Sulfation: Response with sulfur trioxide advanced.

  6. Cristallisation: Managed anti-solvent addition for crystal polymorphism administration.

  7. Lyophilization: Lyophilisation beneath argon ambiance.

7. Scientific & Analysis Purposes

  • Oncologie: Core part of:

    • ABVD (Doxorubicin, Bleomycin, Vinblastine, Dacarbazine)

    • VEBEP (Vinblastine, Etoposide, Bleomycin, Cisplatin)

  • Drug Supply Improvements:

    • Encapsulation liposomale (lowered neurotoxicity)

    • Antibody-drug conjugates (anti-CD30-VLA complexes)

  • Cell Biology: Device compound for mitotic inhibition research.

8. cGMP High quality Management Protocol
Our 360° QC technique contains:

  • Identifiant: ¹H/¹³C NMR spectral match (δ 0.98 ppm, 3H, t; δ 3.70 ppm, 3H, s).

  • Pureté: RP-HPLC-ELSD (Luna C18, 0.1% TFA/MeCN gradient) quantifies vinblastine (≥99.5%), vincristine (≤0.1%).

  • Efficiency: Cell-based mitotic arrest assay (HeLa cells, EC₅₀ ≤2 nM).

  • Security: Bacterial endotoxins (LAL kinetic chromogenic), sterility (membrane filtration USP <71>), solvants résiduels (GC-HS).

  • Stabilité: 36-month shelf-life at 2-8°C (validated per ICH Q1A(R2)).

9. Chilly-Chain Logistics

  • Major Pack: Sort I glass vials (nitrogen headspace) with fluoropolymer-coated stoppers.

  • Pack secondaire : Vacuum-sealed Alu-bags dans UN-certified shippers with temperature loggers.

  • Stockage: 2-8°C protected against gentle; desiccant included.

  • Transport: World cold-chain transport (2-8°C) by way of DHL LifeConEx.

10. Mechanism & Innovation

  • Molecular Motion: Binds β-tubulin vinca website → tubulin dissociation fixed (Kd=6.8 μM) → suppressed GTP hydrolysis → microtubule fragmentation.

  • Zhonghong Improvements:

    • PAT-enabled crystallization (Patent CN202210XXXXXX)

    • Enzymatic dimerization (yield ↑40%)

  • Frontières de l'analyse :

    • Oral formulations (P-glycoprotein inhibitors)

    • Tubulin isotype-selective analogs (βIII-tubulin concentrating on)

  • Défis : Myelosuppression, neuropathy, chemoresistance (ABCB1 overexpression).

11. FAQ

Q1: Can vinblastine be used as a dietary complement?
A: Completely not. Vinblastine is a cytotoxic chemotherapy agent requiring medical supervision. Self-administration is life-threatening.

Q2: How does nattokinase examine for kidney well being?
A: Nattokinase lacks scientific proof for nephroprotection. Vinblastine might trigger nephrotoxicity at excessive doses. Neither compound is indicated for renal situations.

Q3: Why is vincristine impurity management crucial?
*A: Vincristine causes extreme neurotoxicity at microgram doses. Our UPLC-PDA methodology detects ≤0.01% impurity.*

This autumn: What distinguishes Zhonghong’s vinblastine?
*A: cGMP manufacturing, 99.5%+ HPLC purity, endotoxin management (<0.25 EU/mg), and patented crystallization expertise guaranteeing polymorph stability.*

Q5: Do you provide vinblastine for ADC improvement?
A: Sure. GMP-grade linker-conjugated vinblastine (maleimide-PEG₃-vinblastine) accessible for antibody-drug conjugates.

12. World Sourcing
Procure cGMP vinblastine sulfate:
✉️ E-mail: liaodaohai@gmail.com
🌐 Filet: www.aiherba.com
Request: COA, DMF, CEP, and customized synthesis quotations.

13. Conclusion
Vinblastine sulfate stays a cornerstone antineoplastic agent with irreplaceable scientific worth. Its efficacy hinges on ultra-high purity (>99.5%), stringent impurity management (vincristine ≤0.1%), et temperature-controlled dealing with. Shaanxi Zhonghong combines 28 years of vinca alkaloid experience, patented purification expertise, et Conformité aux BPF to ship oncology APIs that meet world pharmacopeial requirements. Associate with us for uncompromising high quality in most cancers therapeutics.

14. Références

  1. Noble RL, et al. (1958). J Am Chem Soc. 80:3487. [DOI:10.1021/ja01546a092]

  2. Jordan MA, et al. (2002). Mol Most cancers Ther. 1:935–943. [PMID:12481413]

  3. WHO Mannequin Record of Important Medicines (2023). Vinblastine sulfate injection.

  4. USP Monograph: Vinblastine Sulfate. USP44-NF39.

  5. EMA Guideline: Specs for cytotoxic APIs (CPMP/QWP/1850/04)

  6. Dumontet C, et al. (2020). Nat Rev Drug Discov. 19:585–608. [DOI:10.1038/s41573-020-0072-8]

  7. Zhonghong Patent: CN202310XXXXXX (Vinblastine crystallization management)

  8. ICH Q3D (R2): Elemental Impurities (2022)

  9. FDA Steerage: Vinblastine Label (NSC-49842)

  10. Gidding CEM, et al. (1999). Most cancers Chemother Pharmacol. 44:266–272. [DOI:10.1007/s002800050976]

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