Винбластин
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Винбластин

Vinblastine supplier bulk factory Wholesale buy Extract factory

  1. Английское имя: Vinblastine
  1. Спецификация
    • Чистота: Vinblastine sulfate ≥ 98% (HPLC); high – purity grade: ≥ 99% (HPLC)
    • Растворимость: Soluble in water (as sulfate salt, ~50 mg/mL), methanol, and ethanol; insoluble in non – polar solvents
    • Внешний вид – Связанный: Потеря при высыхании ≤ 1,0%, тяжелые металлы ≤ 10 ppm, остаточные растворители ≤ 0,5%
    • Размер частиц: Standard powder ≤ 100 μm; micronized powder ≤ 5 μm for better dissolution in formulations
  1. Появление
    • White to off – white crystalline powder (sulfate salt form), odorless
  1. Номер CAS：143-67-9 (Vinblastine); 2068 – 78 – 2 (Vinblastine sulfate)
  1. Время выполнения: 7–10 рабочих дней
  1. Упаковка
    • 10 mg/vial (sterile glass vial), sealed under nitrogen; 100 mg/aluminum foil – lined bag for research – grade products
  1. Главный рынок: Global pharmaceutical and research markets, with significant demand in North America, Europe, and Asia, mainly for oncology treatment and biomedical research
  1. Сценарии применения

Основные свойства

  • Молекулярная формула: C₄₆H₅₈N₄O₉ (Vinblastine); C₄₆H₅₈N₄O₉·2H₂SO₄ (Vinblastine sulfate)
  • Химическая структура: An indole – alkaloid derived from Catharanthus roseus (Madagascar periwinkle), consisting of a complex dimeric structure with two linked indole rings.
  • Ключевые особенности
    • 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.
    • Низкая биодоступность: 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).

Сценарии применения

1. Лечение онкологии

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

2. Биомедицинские исследования

  • Исследования клеточной биологии:
    • 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.
  • Разработка лекарств:
    • 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. Ветеринарная онкология

  • 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.

Методы обнаружения

  • Высокоэффективная жидкостная хроматография (ВЭЖХ):
    • 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.
  • Жидкостная хроматография – масс-спектрометрия (ЖХ – МС):
    • Used for identifying vinblastine and its metabolites in biological samples, providing high – sensitivity detection and confirmation of the compound’s structure.
  • УФ-видимая спектроскопия:
    • Quick – screening method to estimate vinblastine concentration based on its characteristic absorption peak at 262 nm, useful for initial quality control and batch analysis.

Источник и преимущества

  • Натуральный источник: 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.
  • Терапевтическое значение: A cornerstone in cancer chemotherapy, having significantly improved survival rates for several types of cancer since its discovery.
  • Ценность исследования: A fundamental tool in biological research, facilitating the understanding of basic cellular processes and driving innovation in cancer treatment strategies.

Соблюдение нормативных требований

  • Управление по санитарному надзору за качеством пищевых продуктов и медикаментов США: 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 (Европейское агентство по лекарственным средствам): Licensed for use in oncology, with continuous pharmacovigilance to monitor adverse effects and ensure patient safety.
  • Китайская NMPA: Registered for clinical use in cancer treatment, subject to Good Manufacturing Practice (GMP) requirements and regular quality inspections.
Категории: ,

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 и mitotic disaster in quickly proliferating cells. Acknowledged as an важные лекарства by WHO, it is clinically indispensable for treating Hodgkin lymphoma, testicular most cancers, and superior breast carcinoma.

2. Поставки, химические свойства и идентификаторы

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

  • Химические свойства:

    • Химическое название: 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

    • Молекулярная формула: C₄₆H₅₈N₄O₉ · H₂SO₄

    • Молекулярный вес: 909.06 g/mol

    • Появление: White to off-white hygroscopic crystalline powder

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

    • Стабильность: Mild-sensitive; oxidizes beneath alkaline situations

  • Ключевые идентификаторы:

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

    • Количество ЕС (EINECS): 205-620-3

    • МФ: C₄₆H₆₀N₄O₁₃S

    • МВ: 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 и crystallization controls.

  • Therapeutic Purposes:

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

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

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

  • Дозировка:

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

  • Vital Security Profile:

    • Hematologic: Экстремальный 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.

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

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

  • Scientific Infrastructure:

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

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

  • Аналитическое превосходство:

    • 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 Более 80 международных локаций beneath cold-chain protocols.

5. Строгие высококачественные характеристики

Сорт Параметр Спецификация Техника
Пестициды Дихлофос ≤0,01 мг/кг GC-MS/MS (EU 2021/601)
Малатион ≤0,05 мг/кг ГХ-МС/МС
Тяжелые металлы свинец ≤1 ppm ИСП-МС (USP <232>)
Как ≤0,5 частей на миллион ИСП-МС
Микробиология ТАМЦ ≤10² CFU/g USP <61>
Bile-tolerant GNR Отсутствует/10г USP <62>
Vital Attributes Vinblastine Sulfate ≥99.5% HPLC-ELSD (USP <621>)
Винкристин ≤0,1% UPLC-PDA
Water Content ≤5.0% Карл Фишер
Эндотоксины <0,25 ЕЭ/мг 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. Кристаллизация: Managed anti-solvent addition for crystal polymorphism administration.

  7. Лиофилизация: Сублимационная сушка beneath argon ambiance.

7. Scientific & Analysis Purposes

  • Онкология: Core part of:

    • ABVD (Doxorubicin, Bleomycin, Vinblastine, Dacarbazine)

    • VEBEP (Vinblastine, Etoposide, Bleomycin, Cisplatin)

  • Улучшение снабжения лекарствами:

    • Liposomal encapsulation (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:

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

  • Чистота: 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), стерильность (membrane filtration USP <71>), остаточные растворители (GC-HS).

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

9. Chilly-Chain Logistics

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

  • Вторичный пакет: Vacuum-sealed Alu-bags в UN-certified shippers with temperature loggers.

  • Хранилище: 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%)

  • Границы анализа:

    • Oral formulations (P-glycoprotein inhibitors)

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

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

11. Часто задаваемые вопросы

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:
✉️ Электронная почта: liaodaohai@gmail.com
🌐 Сеть: www.aiherba.com
Request: COA, DMF, CEP, and customized synthesis quotations.

13. Заключение
Vinblastine sulfate stays a cornerstone antineoplastic agent with irreplaceable scientific worth. Its efficacy hinges on сверхвысокой чистоты (>99,5%), stringent impurity management (vincristine ≤0.1%), и temperature-controlled dealing with. Шэньси Чжунхун объединяет 28 years of vinca alkaloid experience, patented purification expertise, и соответствие cGMP to ship oncology APIs that meet world pharmacopeial requirements. Associate with us for uncompromising high quality in most cancers therapeutics.

14. Ссылки

  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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