Vincristine
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Vincristine

Vincristine supplier bulk factory Wholesale buy Extract factory

  1. Nom anglais: Vincristine
  1. Spécification
    • Pureté: Vincristine sulfate ≥ 98% (HPLC); high – purity grade: ≥ 99% (HPLC)
    • Solubilité: Soluble in water (as sulfate salt, approximately 10 mg/mL), ethanol; insoluble in non – polar solvents like chloroform
    • Apparence – liée: Perte au séchage ≤ 1,0%, métaux lourds ≤ 10 ppm, solvants résiduels ≤ 0,5%
    • Taille des particules: Standard powder ≤ 100 μm; micronized powder ≤ 5 μm for better dissolution in parenteral formulations
  1. Apparence
    • Poudre cristalline blanche à blanc cassé (sous forme de sel de sulfate), inodore
  1. N° CAS：2068 – 78 – 2 (Vincristine sulfate); 57 – 22 – 7 (Vincristine base)
  1. Délai de mise en œuvre: 7 à 10 jours ouvrables
  1. Emballer
    • 1 mg/vial (sterile glass vial), sealed under nitrogen; 10 mg/aluminum foil – lined bag for research – grade products
  1. Marché principal: Global pharmaceutical market, especially in North America, Europe, and Asia, predominantly used in oncology treatment and biomedical research
  1. Scénarios d'application

Propriétés de base

  • Formule moléculaire: C₄₇H₅₅N₅O₁₁ (Vincristine); C₄₇H₅₅N₅O₁₁·H₂SO₄ (Vincristine sulfate)
  • Structure chimique:Un indole – alcaloïde dérivé de Catharanthus roseus (Madagascar periwinkle), featuring a complex dimeric structure with a unique arrangement of indole and vindoline moieties.
  • Caractéristiques principales
    • Agent antimitotique: Binds to tubulin subunits, inhibiting microtubule polymerization. This disrupts the formation of the mitotic spindle during cell division, leading to cell cycle arrest at the metaphase stage and subsequent apoptosis of rapidly dividing cells.
    • High Selectivity for Neurons: While effective against cancer cells, it also has significant neurotoxicity due to its affinity for microtubules in neurons, affecting axonal transport and leading to peripheral neuropathy.
    • Faible biodisponibilité: Oral absorption is negligible, thus it is primarily administered intravenously for therapeutic use.
    • Potent Cytotoxicity: Even at low doses, it exhibits strong antitumor activity, but careful dosing is required to balance efficacy and minimize side effects.

Scénarios d'application

1. Traitement oncologique

  • Pediatric Cancers:
    • A crucial component in the treatment of acute lymphoblastic leukemia (ALL) in children, often used in combination regimens like VDLP (vincristine, daunorubicin, L – asparaginase, prednisone). It significantly improves remission rates, with cure rates for pediatric ALL exceeding 80% in many cases.
  • Adult Hematological Malignancies:
    • Used in the treatment of Hodgkin’s lymphoma and non – Hodgkin’s lymphoma, commonly included in combination chemotherapy protocols such as CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) for non – Hodgkin’s lymphoma, enhancing treatment efficacy.
  • Solid Tumors:
    • Applied as part of adjuvant or palliative therapy for solid tumors like neuroblastoma, rhabdomyosarcoma, and Wilms’ tumor, either alone or in combination with other chemotherapeutic agents to control tumor growth and improve patient prognosis.

2. Recherche biomédicale

  • Études de biologie cellulaire:
    • Serves as a valuable tool for studying microtubule – dependent cellular processes, including cell division, intracellular transport, and cell motility. By disrupting microtubule dynamics, researchers can observe the impact on various cellular functions and signaling pathways.
  • Développement de médicaments:
    • Used as a reference compound for developing novel antimitotic drugs. Its structure and mechanism of action inspire the design of analogs with potentially improved therapeutic indices, reduced toxicity, and enhanced selectivity for cancer cells.
  • Neurotoxicity Research:
    • Investigated to understand the mechanisms of chemotherapy – induced peripheral neuropathy. Studying vincristine – induced neurotoxicity helps in developing strategies to prevent or mitigate this common and debilitating side effect of cancer treatment.

Méthodes de détection

  • Chromatographie liquide à haute performance (HPLC):
    • Column: C18 (250 × 4.6 mm, 5 μm), Mobile Phase: Acetonitrile – 0.1% formic acid (gradient elution), Flow Rate: 1.0 mL/min, Detection Wavelength: 297 nm for quantification.
  • Chromatographie liquide – Spectrométrie de masse (LC – MS):
    • Employed for identifying vincristine and its metabolites in biological samples with high sensitivity. It provides detailed information about the compound’s structure and enables accurate quantification even at trace levels.
  • Spectroscopie UV-Visible:
    • Utilized as a rapid screening method to estimate vincristine concentration based on its characteristic absorption peak at 297 nm, useful for initial quality control and batch analysis during manufacturing.

Source et avantages

  • Source naturelle: Initially isolated from the leaves and stems of Catharanthus roseus. Due to the low natural yield (about 0.0001 – 0.001% dry weight) and environmental concerns, semi – synthetic and synthetic production methods are now predominantly used to meet the global demand.
  • Therapeutic Importance: A cornerstone in cancer chemotherapy, especially for hematological malignancies and certain pediatric cancers, where it has significantly improved survival rates and patient outcomes.
  • Research Significance: Facilitates fundamental research in cell biology and oncology, driving advancements in understanding cancer mechanisms and the development of more effective cancer treatments.

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 are enforced to ensure the quality and efficacy of vincristine – based products.
  • EMA (Agence européenne des médicaments): Licensed for use in oncology, with continuous pharmacovigilance programs in place to monitor adverse effects and ensure patient safety throughout the product lifecycle.
  • NMPA de Chine: Registered for clinical use in cancer treatment, subject to Good Manufacturing Practice (GMP) requirements and regular quality inspections to comply with national pharmaceutical standards.
Catégories : ,

Vincristine Sulfate: The Microtubule-Concentrating on Chemotherapy Agent Revolutionizing Oncology | Supplier & Manufacturer

1. What is Vincristine?

Vincristine sulfate is a dimeric Catharanthus alkaloid dérivé du Pervenche de Madagascar (Catharanthus roseus). As a microtubule-disrupting agent, it binds with excessive affinity to β-tubulin on the zone de pervenche, inhibiting microtubule polymerization and disrupting mitotic spindle meeting. Cela déclenche metaphase arrest et apoptosis in quickly dividing cells. Labeled as a WHO Important Medication, it is clinically indispensable for treating acute leukemias, lymphomas, and strong tumors via its potent antimitotic exercise.

2. Approvisionnement, propriétés chimiques et identifiants

  • Fournir: Remoted from Catharanthus roseus leaves; semi-synthesized from precursors catharanthine and vindoline

  • Propriétés chimiques :

    • Nom chimique : Methyl (2β,3β,4β,5α,12β,19α)-15-[(5S,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]-3-hydroxy-16-methoxy-1-methyl-6,7-didehydroaspidospermidine-3-carboxylate sulfate

    • Méthode moléculaire : C₄₆H₅₆N₄O₁₀·H₂SO₄

    • Poids moléculaire : 923.04 g/mol

    • Apparence: White to off-white hygroscopic powder

    • Solubilité: Freely soluble in water (30 mg/mL), sparingly soluble in ethanol

    • Stabilité: Gentle-sensitive; degrades above pH 5.5

  • Identifiants clés :

    • CAS: 2068-78-2 (vincristine sulfate)

    • Quantité CE (EINECS) : 218-216-0

    • MF: C₄₆H₅₈N₄O₁₄S

    • MW: 923.04

3. Pharmaceutical-Grade Specs & Scientific Profile

  • Produit optimal : Nécessite Pureté HPLC >99,5%, <0.1% vinblastine (poisonous analog), and endotoxin-free (<0.25 EU/mg). Shaanxi Zhonghong achieves this via chromatographie à contre-courant et lyophilization stabilization.

  • Objectifs thérapeutiques :

    • Oncologie: Première ligne pour ALL (induction remedy), Hodgkin/non-Hodgkin lymphoma, neuroblastoma, Wilm’s tumor

    • Mécanisme: Liaisons tubulin dimer (Kd=85 nM) → suppresses microtubule dynamics → catastrophe mitotique

    • (Observe: Nattokinase demonstrates fibrinolytic exercise; no medical proof helps nephroprotective advantages)

  • Dosage:

    • IV Administration Solely: 1.4-2.0 mg/m² weekly (max 2 mg/dose)

    • No oral bioavailability; by no means self-administer

  • Crucial Security Profile:

    • Neurotoxicité : Dose-limiting peripheral neuropathy (sensory > motor)

    • Hématologique : Delicate myelosuppression (in contrast to vinblastine)

    • Autonomic Results: Ileus, bladder atony, orthostatic hypotension

    • Extravasation Threat: Extreme tissue necrosis requiring central line

    • Contre-indications : Charcot-Marie-Tooth illness, intrathecal administration (deadly)

4. Shaanxi Zhonghong: cGMP Vinca Alkaloid Specialist
Avec Plus de 28 ans d'expérience dans le domaine des API oncologiques d'origine végétale, we produce EP/USP-compliant vincristine sulfate:

  • Infrastructure scientifique :

    • 5 College Joint Labs (Tubulin binding analysis)

    • Patented Tech: CN202310XXXXXX (Vindoline stabilization)

  • Capacités analytiques :

    • UPLC-MS/MS (purity/impurities)

    • 600MHz NMR (affirmation structurelle)

    • ICP-MS (elemental impurities)

    • LAL Chromogenic (endotoxins)

  • World Distribution: API shipments to Plus de 80 sites internationaux with cold-chain compliance

5. Pharmaceutical High quality Specs

Classe Paramètre Spécification Technique
Pesticides Chlorpyrifos ≤ 0,01 mg/kg GC-MS/MS
Diméthoate ≤0.02 mg/kg LC-MS/MS
Métaux lourds Pb ≤ 1,0 ppm ICP-MS (USP <232>)
CD ≤ 0,5 ppm ICP-MS
Microbiologie TAMC ≤10² UFC/g USP <61>
E. coli Absent/10g USP <62>
Crucial Attributes Vincristine Sulfate ≥99,5% HPLC-PDA (USP <621>)
Vinblastine ≤0,1% UPLC-MS
Teneur en eau ≤4.0% Karl Fischer
Endotoxines <0,25 UE/mg LAL (USP <85>)

6. Cours de fabrication cGMP

  1. Botanical Sourcing: C. roseus cultivated underneath GACP tips

  2. Extraction d'alcaloïdes : Ethanol/water gradient extraction (pH 4.0)

  3. Precursor Isolation: Ion-exchange chromatography (vindoline)

  4. Oxidative Coupling: Fe³⁺/H₂O₂-mediated dimerization

  5. Sulfatation : Réponse avec SO₃-pyridine complicated

  6. Cristallisation: Managed polymorph formation (Type II crystals)

  7. Lyophilisation : -50°C freeze-drying underneath nitrogen environment

  8. Filtration stérile : 0.22 µm membrane filtration

7. Fins scientifiques et analytiques

  • Oncology Protocols:

    • R-CHOP (lymphoma)

    • VDCLP (pediatric ALL)

  • Méthodes d'approvisionnement en médicaments :

    • Encapsulation liposomale (Marqibo®)

    • Peptide-drug conjugates (tumor-targeted supply)

  • Neuroscience Analysis:

    • Axonal transport research

    • Neurotoxicity modeling

8. Protocole de gestion de haute qualité cGMP
Zhonghong’s 360° QC consists of:

  • Identification: ¹³C NMR (C-18/C-19 carbonyl resonance at 175.2 ppm)

  • Pureté: HPLC-ELSD quantifies vincristine (≥99.5%) and vinblastine (≤0.1%)

  • Efficacité: Tubulin polymerization assay (IC₅₀ 0.1-0.3 μM)

  • Sécurité: Endotoxines bactériennes (kinetic chromogenic LAL), sterility testing (USP <71>)

  • Stabilité: 24-month shelf-life at 2-8°C (ICH Q1A validated)

9. Chilly-Chain Packaging & Logistics

  • Main Container: Sort I amber vials (nitrogen headspace)

  • Emballage secondaire : Vacuum-sealed Alu-PET pouches with desiccant

  • Stockage: 2-8°C shielded from gentle

  • Delivery: Transport mondial sous chaîne du froid (2-8°C) by way of DHL Thermonet

10. Mechanism & Improvements

  • Mouvement moléculaire :

    • Excessive-affinity binding to βIII-tubulin isotype

    • Supprime microtubule dynamic instability by 95%

    • Induit Bim-mediated apoptosis

  • Améliorations de Zhonghong :

    • dimérisation enzymatique (yield ↑35%)

    • Cryogenic milling for particle dimension management

  • Frontières de l'analyse :

    • Tubulin isotype-specific analogs

    • Neuroprotective co-administration (glutamate antagonists)

  • Défis :

    • Neurotoxicity administration

    • ABC transporter-mediated resistance

11. FAQ

Q1: Can vincristine be used as a dietary complement?
A: Completely not. Vincristine is a cytotoxic chemotherapy agent requiring medical supervision. Unauthorized use causes extreme neurotoxicity.

Q2: Does nattokinase profit kidney sufferers?
*A: No medical proof helps nattokinase for kidney illness. Vincristine requires dose adjustment in renal impairment (CrCl <30 mL/min).*

Q3: Why is vinblastine impurity managed?
*A: Vinblastine causes distinct myelotoxicity. Our UPLC-MS detects ≤0.05% impurity (ICH Q3A limits).*

This autumn: What distinguishes Zhonghong’s vincristine?
*A: cGMP manufacturing, ≥99.5% purity, endotoxin management (<0.25 EU/mg), and patented lyophilization expertise.*

Q5: Do you provide vincristine for ADCs?
*A: Sure. GMP-grade maleimide-activated vincristine accessible for antibody-drug conjugates (DAR 4-8).*

12. World Procurement
Supply cGMP vincristine sulfate:
✉️ E-mail: liaodaohai@gmail.com
🌐 Filet: www.aiherba.com
Request: COA, DMF, regulatory help, and customized synthesis choices.

13. Conclusion
Vincristine sulfate stays a cornerstone of pediatric and hematologic oncology with distinctive microtubule-targeting properties. Its medical utility is dependent upon ultra-haute pureté (>99,5%), stringent neurotoxic impurity management, et temperature-managed distribution. Shaanxi Zhonghong combine three many years of vinca alkaloid experience, patented stabilization expertise, et Conformité aux BPF to ship APIs assembly international 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. (1985). J Biol Chem. 260:14608. [PMID:2995464]

  3. WHO EML (2023): Vincristine sulfate injection

  4. USP Monograph: Vincristine Sulfate. USP44-NF39

  5. EMA Guideline CPMP/QWP/1850/04

  6. Lobert S, et al. (1996). Biochimie. 35:6806. [DOI:10.1021/bi952483n]

  7. Zhonghong Patent: CN202310XXXXXX (Cryo-milling course of)

  8. ICH Q3D (R2): Elemental Impurities

  9. FDA Label: Vincristine Sulfate Injection

  10. Gidding CEM, et al. (1999). Chimiothérapie contre le cancer Pharmacol. 44:266. [DOI:10.1007/s002800050976]

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