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Vinblastin

Vinblastine supplier bulk factory Wholesale buy Extract factory

  1. Anglický název: Vinblastine
  1. Specifikace
    • Čistota: Vinblastine sulfate ≥ 98% (HPLC); high – purity grade: ≥ 99% (HPLC)
    • Rozpustnost: Soluble in water (as sulfate salt, ~50 mg/mL), methanol, and ethanol; insoluble in non – polar solvents
    • Vzhled – související: Loss on drying ≤ 1.0%, heavy metals ≤ 10 ppm, residual solvents ≤ 0.5%
    • Velikost částic: Standard powder ≤ 100 μm; micronized powder ≤ 5 μm for better dissolution in formulations
  1. Vzhled
    • White to off – white crystalline powder (sulfate salt form), odorless
  1. ČÍSLO CAS:143-67-9 (Vinblastine); 2068 – 78 – 2 (Vinblastine sulfate)
  1. Dodací lhůta7 – 10 pracovních dnů
  1. Balík
    • 10 mg/vial (sterile glass vial), sealed under nitrogen; 100 mg/aluminum foil – lined bag for research – grade products
  1. Hlavní trh: Global pharmaceutical and research markets, with significant demand in North America, Europe, and Asia, mainly for oncology treatment and biomedical research
  1. Scénáře aplikací

Základní vlastnosti

  • Molekulární vzorec: C₄₆H₅₈N₄O₉ (Vinblastine); C₄₆H₅₈N₄O₉·2H₂SO₄ (Vinblastine sulfate)
  • Chemická struktura: An indole – alkaloid derived from Catharanthus roseus (Madagascar periwinkle), consisting of a complex dimeric structure with two linked indole rings.
  • Klíčové vlastnosti
    • 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.
    • Nízká biologická dostupnost: Oral absorption is poor; typically administered intravenously for therapeutic use.
    • High Potency: Requires careful dosage control due to significant toxicity to rapidly dividing normal cells (e.g., bone marrow, gastrointestinal tract).

Scénáře aplikací

1. Onkologická léčba

  • 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.
  • Adjuvantní terapie:
    • Given after surgery or radiation to reduce the risk of cancer recurrence by targeting remaining cancer cells.

2. Biomedicínský výzkum

  • Studie buněčné biologie:
    • 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.
  • Vývoj léčiv:
    • 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. Veterinární onkologie

  • 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.

Detekční metody

  • Vysoce účinná kapalinová chromatografie (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.
  • Kapalinová chromatografie – hmotnostní spektrometrie (LC – MS):
    • Used for identifying vinblastine and its metabolites in biological samples, providing high – sensitivity detection and confirmation of the compound’s structure.
  • UV – Viditelná spektroskopie:
    • Quick – screening method to estimate vinblastine concentration based on its characteristic absorption peak at 262 nm, useful for initial quality control and batch analysis.

Zdroj a výhody

  • Přírodní zdroj: 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.
  • Terapeutický význam: 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.

Dodržování předpisů

  • Americký úřad pro kontrolu potravin a léčiv (FDA): 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 (Evropská agentura pro léčivé přípravky): Licensed for use in oncology, with continuous pharmacovigilance to monitor adverse effects and ensure patient safety.
  • Čínská NMPA: Registered for clinical use in cancer treatment, subject to Good Manufacturing Practice (GMP) requirements and regular quality inspections.

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 G2/M part arrest a mitotic disaster in quickly proliferating cells. Acknowledged as an důležité léky by WHO, it is clinically indispensable for treating Hodgkin lymphoma, testicular most cancers, and superior breast carcinoma.


2. Supply, Chemical Properties & Identifiers

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

  • Chemické vlastnosti:

    • Chemický název: 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

    • Molecular Formulation: C₄₆H₅₈N₄O₉ · H₂SO₄

    • Molekulová hmotnost: 909.06 g/mol

    • Vzhled: White to off-white hygroscopic crystalline powder

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

    • Stabilita: Mild-sensitive; oxidizes beneath alkaline situations

  • Klíčové identifikátory:

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

    • Množství ES (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 a crystallization controls.

  • Therapeutic Purposes:

    • Onkologie: First-line for Hodgkin’s lymphoma (ABVD routine)NSGCTchoriocarcinomaKaposi sarcoma.

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

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

  • Dávkování:

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

  • Vital Security Profile:

    • Hematologic: Extrémní 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.

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


4. Shaanxi Zhonghong: Pioneering Vinca Alkaloid Manufacturing
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)

  • Analytická nadřazenost:

    • 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 Více než 80 mezinárodních poboček beneath cold-chain protocols.


5. Rigorous High quality Specs

Třída Parametr Specifikace Technika
Pesticidy Dichlorvos ≤0,01 mg/kg GC-MS/MS (EU 2021/601)
Malathion ≤0,05 mg/kg GC-MS/MS
Těžké kovy Olovo ≤1 ppm ICP-MS (USP <232>)
Jako ≤0,5 ppm ICP-MS
Mikrobiologie TAMC ≤10² CFU/g USP <61>
Bile-tolerant GNR Chybí/10 g USP <62>
Vital Attributes Vinblastine Sulfate ≥99,5% HPLC-ELSD (USP <621>)
Vinkristin ≤0,1% UPLC-PDA
Water Content ≤5.0% Karl Fischer
Endotoxiny <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. Chromatographic Separation: Flash chromatography → HPLC purification (vindoline/catharanthine).

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

  5. Sulfation: Response with sulfur trioxide advanced.

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

  7. Lyofilizace: Lyofilizace beneath argon ambiance.


7. Scientific & Analysis Purposes

  • Onkologie: Core part of:

    • ABVD (Doxorubicin, Bleomycin, Vinblastine, Dacarbazine)

    • VEBEP (Vinblastine, Etoposide, Bleomycin, Cisplatin)

  • Drug Supply Improvements:

    • Liposomální zapouzdření (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:

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

  • Čistota: 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).

  • Zabezpečení: Bacterial endotoxins (LAL kinetic chromogenic), sterility (membrane filtration USP <71>), zbytková rozpouštědla (GC-HS).

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


9. Chilly-Chain Logistics

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

  • Sekundární balíček: Vacuum-sealed Alu-bags v UN-certified shippers with temperature loggers.

  • Skladování: 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%)

  • Hranice analýzy:

    • Oral formulations (P-glycoprotein inhibitors)

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

  • Výzvy: Myelosuppressionneuropathychemoresistance (ABCB1 overexpression).


11. Často kladené otázky

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
🌐 Síť: www.aiherba.com
Request: COA, DMF, CEP, and customized synthesis quotations.


13. Závěr
Vinblastine sulfate stays a cornerstone antineoplastic agent with irreplaceable scientific worth. Its efficacy hinges on ultravysoká čistota (>99,5%)stringent impurity management (vincristine ≤0.1%)temperature-controlled dealing with. Shaanxi Zhonghong combines 28 years of vinca alkaloid experiencepatented purification expertiseSoulad s cGMP to ship oncology APIs that meet world pharmacopeial requirements. Associate with us for uncompromising high quality in most cancers therapeutics.


14. Odkazy

  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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