Vinblastin
,

Vinblastin

Vinblastine supplier bulk factory Wholesale buy Extract factory

  1. İngilis adı: Vinblastine
  1. Spesifikasiya
    • Saflıq: Vinblastine sulfate ≥ 98% (HPLC); high – purity grade: ≥ 99% (HPLC)
    • Həlledicilik: Soluble in water (as sulfate salt, ~50 mg/mL), methanol, and ethanol; insoluble in non – polar solvents
    • Appearance – Related: Qurutma itkisi ≤ 1.0%, ağır metallar ≤ 10 ppm, qalıq həlledicilər ≤ 0.5%
    • Hissəcik ölçüsü: Standard powder ≤ 100 μm; micronized powder ≤ 5 μm for better dissolution in formulations
  1. Görünüş
    • Ağdan ağ rəngə qədər – ağ kristal toz (sulfat duzu forması), qoxusuz
  1. CAS NO.：143-67-9 (Vinblastine); 2068 – 78 – 2 (Vinblastine sulfate)
  1. Təqdimat vaxtı: 7 – 10 İş Günü
  1. Paket
    • 10 mg/vial (sterile glass vial), sealed under nitrogen; 100 mg/aluminum foil – lined bag for research – grade products
  1. Əsas bazar: Global pharmaceutical and research markets, with significant demand in North America, Europe, and Asia, mainly for oncology treatment and biomedical research
  1. Tətbiq Ssenariləri

Əsas Xüsusiyyətlər

  • Molekulyar Formula: C₄₆H₅₈N₄O₉ (Vinblastine); C₄₆H₅₈N₄O₉·2H₂SO₄ (Vinblastine sulfate)
  • Kimyəvi quruluş: Bir indol - əldə edilən alkaloid Catharanthus roseus (Madagascar periwinkle), consisting of a complex dimeric structure with two linked indole rings.
  • Əsas Xüsusiyyətlər
    • Antimitotik 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.
    • Aşağı bioavailability: Oral absorption is poor; typically administered intravenously for therapeutic use.
    • Yüksək Potensiya: Requires careful dosage control due to significant toxicity to rapidly dividing normal cells (e.g., bone marrow, gastrointestinal tract).

Tətbiq Ssenariləri

1. Onkoloji Müalicə

  • 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. Biotibbi Tədqiqatlar

  • Hüceyrə Biologiyası Tədqiqatları:
    • 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.
  • Dərman İnkişafı:
    • 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. Baytarlıq Onkologiyası

  • 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.

Aşkarlama üsulları

  • Yüksək Performanslı Maye Xromatoqrafiyası (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.
  • Maye Xromatoqrafiyası - Kütləvi Spektrometriya (LC - MS):
    • Used for identifying vinblastine and its metabolites in biological samples, providing high – sensitivity detection and confirmation of the compound’s structure.
  • UV - Görünən Spektroskopiya:
    • Quick – screening method to estimate vinblastine concentration based on its characteristic absorption peak at 262 nm, useful for initial quality control and batch analysis.

Mənbə və Üstünlüklər

  • Təbii Mənbə: 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.
  • Terapevtik əhəmiyyəti: 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.

Tənzimləmə Uyğunluğu

  • ABŞ 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 (Avropa Dərman Agentliyi): Licensed for use in oncology, with continuous pharmacovigilance to monitor adverse effects and ensure patient safety.
  • Çin NMPA: Registered for clinical use in cancer treatment, subject to Good Manufacturing Practice (GMP) requirements and regular quality inspections.
Kateqoriyalar: ,

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 -dən əldə edilmişdir Madaqaskar periwinkle (Catharanthus roseus). As a potent microtubule-destabilizing agent, it binds to β-tubulin subunits on the vinca sahəsi, inhibiting microtubule meeting and suppressing mitotic spindle formation. Bu tetikler G2/M hissəsinin həbsi və mitotik fəlakət in quickly proliferating cells. Acknowledged as an mühüm dərmanlar by WHO, it is clinically indispensable for treating Hodgkin lymphoma, testicular most cancers, and superior breast carcinoma.

2. Təchizat, Kimyəvi Xüsusiyyətlər və İdentifikatorlar

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

  • Kimyəvi xassələri:

    • Kimyəvi adı: 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

    • Molekulyar formula: C₄₆H₅₈N₄O₉ · H₂SO₄

    • Molekulyar Çəki: 909.06 g/mol

    • Görünüş: White to off-white hygroscopic crystalline powder

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

    • Sabitlik: Mild-sensitive; oxidizes beneath alkaline situations

  • Açar identifikatorlar:

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

    • EC Miqdarı (EINECS): 205-620-3

    • MF: C₄₆H₆₀N₄O₁₃S

    • MV: 909.06

3. Pharmaceutical-Grade High quality & Scientific Profile

  • Optimal məhsul: Tələb edir >99.5% HPLC təmizliyi, <0.1% vincristine (poisonous isomer), and undetectable endotoxins (<0.25 EU/mg). Shaanxi Zhonghong ensures this by way of əks cərəyan xromatoqrafiyası və crystallization controls.

  • Terapevtik Məqsədlər:

    • Onkologiya: Üçün birinci sıra Hodgkin’s lymphoma (ABVD routine), NSGCT, choriocarcinoma, Kaposi sarcoma.

    • Mexanizm: Bağlayır tubulin → depolymerizes microtubules → blocks metaphase → apoptosis.

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

  • Dozaj:

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

  • Vital Security Profile:

    • Hematoloji: Ekstremal neutropenia (nadir Day 7-10), thrombocytopenia.

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

    • GI Results: Nausea, constipation, ileus.

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

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

4. Shaanxi Zhonghong: Pioneering Vinca Alkaloid Manufacturing
ilə Bitki mənşəli onkologiya API-lərində 28+ il, we ship cGMP vinblastine sulfate assembly USP/EP monographs. Core strengths:

  • Elmi İnfrastruktur:

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

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

  • Analitik üstünlük:

    • HPLC-ELSD/MS (purity)

    • UPLC-PDA (isomeric impurity management)

    • Superconducting 600MHz NMR (struktur təsdiqi)

    • LAL Endotoxin Testing (<0.25 EU/mg)

  • World Provide: APIs shipped to 80+ beynəlxalq məkan beneath cold-chain protocols.

5. Rigorous High quality Specs

Sinif Parametr Spesifikasiya Texnika
Pestisidlər Dichlorvos ≤0,01 mq/kq GC-MS/MS (EU 2021/601)
Malation ≤0.05 mg/kg GC-MS/MS
Ağır metallar Pb ≤1 ppm ICP-MS (USP <232>)
kimi ≤0,5 ppm ICP-MS
Mikrobiologiya TAMC ≤10² CFU/q USP <61>
Bile-tolerant GNR Yoxdur/10q USP <62>
Vital Attributes Vinblastine Sulfate ≥99,5% HPLC-ELSD (USP <621>)
Vinkristin ≤0,1% UPLC-PDA
Su tərkibi ≤5.0% Karl Fişer
Endotoksinlər <0,25 AB/mq LAL (USP <85>)

6. cGMP İstehsalat Kursu

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

  2. Alkaloidlərin çıxarılması: 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. Sulfasiya: ilə cavab verin sulfur trioxide advanced.

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

  7. Liyofilizasiya: Donduraraq qurutma beneath argon ambiance.

7. Elmi və Təhlil Məqsədləri

  • Onkologiya: Core part of:

    • ABVD (Doxorubicin, Bleomycin, Vinblastine, Dacarbazine)

    • VEBEP (Vinblastine, Etoposide, Bleomycin, Cisplatin)

  • Drug Supply Improvements:

    • Liposom kapsulyasiyası (lowered neurotoxicity)

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

  • Cell Biology: Device compound for mitotic inhibition research.

8. cGMP Yüksək keyfiyyətli İdarəetmə Protokolu
Our 360° QC technique contains:

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

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

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

  • Təhlükəsizlik: Bakterial endotoksinlər (LAL kinetic chromogenic), sterility (membrane filtration USP <71>), residual solvents (GC-HS).

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

9. Chilly-Chain Logistics

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

  • İkinci paket: Vacuum-sealed Alu-bags in UN-certified shippers with temperature loggers.

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

  • Transport: Dünya soyuq zəncirli nəqliyyat (2-8°C) by way of DHL LifeConEx.

10. Mechanism & Innovation

  • Molekulyar Hərəkət: Bağlayır β-tubulin vinca website → tubulin dissociation fixed (Kd=6.8 μM) → suppressed GTP hydrolysis → microtubule fragmentation.

  • Zhonghong Təkmilləşdirmələri:

    • PAT-enabled crystallization (Patent CN202210XXXXXX)

    • Enzimatik dimerləşmə (yield ↑40%)

  • Təhlil Sərhədləri:

    • Oral formulations (P-glycoprotein inhibitors)

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

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

11. Tez-tez verilən suallar

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-poçt: liaodaohai@gmail.com
🌐 Net: www.aiherba.com
Request: COA, DMF, CEP, and customized synthesis quotations.

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

14. İstinadlar

  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). Ən çox xərçəng Chemother Pharmacol. 44:266–272. [DOI:10.1007/s002800050976]

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