Imatinib

Imatinib

Parámetro Especificaciones
Nombre del producto Imatinib
Número CAS 152459-95-5
Fórmula molecular C29H31N7O
Peso molecular 493.60 g/mol
Apariencia Polvo cristalino de color blanco a blanquecino
Ensayo (HPLC) ≥99,01 TP3T
Solubilidad Soluble in DMSO, slightly soluble in ethanol, practically insoluble in water
Paquete 1 kg, 5 kg, 25 kg drums

Imatinib Structure

Sinónimos: Imatinib, Gleevec, Glivec, STI-571, CGP 57148B, 4-[(4-methylpiperazin-1-yl)methyl]-N-(4-methyl-3-{[4-(pyridin-3-yl)pyrimidin-2-yl]amino}phenyl)benzamide

Imatinib is a small-molecule tyrosine kinase inhibitor that changed the treatment paradigm for chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). Developed by Novartis and first approved in 2001, it remains a cornerstone of targeted cancer therapy and a high-demand API for generic manufacturers worldwide. As a phenylaminopyrimidine derivative, imatinib selectively inhibits BCR-ABL, c-KIT, and PDGFR kinases, offering a precise mechanism of action that has made it a benchmark in oncology.

Chemically, imatinib mesylate is the marketed salt form, but the free base is also supplied for research and formulation development. Its structure features a pyrimidine core linked to a benzamide moiety, with a methylpiperazine group enhancing solubility. This design allows for oral bioavailability and metabolic stability, distinguishing it from earlier, less selective kinase inhibitors. The compound is synthesized through a multi-step process involving palladium-catalyzed coupling and amide bond formation, yielding a highly pure active pharmaceutical ingredient (API) that meets stringent pharmacopeial standards.

In the B2B pharmaceutical supply chain, imatinib is primarily used in the production of generic oncology drugs. It is also a key reference standard in analytical laboratories and a starting point for next-generation kinase inhibitor research. LyvBio supplies imatinib API with consistent quality, supported by comprehensive documentation and reliable lead times to meet the demands of formulation companies and research organizations.

Function & Mechanism

  • BCR-ABL inhibition: Binds to the ATP-binding site of the BCR-ABL fusion protein, blocking downstream signaling that drives CML cell proliferation.
  • c-KIT inhibition: Targets mutant c-KIT receptors in GIST, leading to reduced tumor growth and improved clinical outcomes.
  • PDGFR inhibition: Inhibits platelet-derived growth factor receptors, affecting tumor stroma and angiogenesis.
  • Selectivity: Sparing many normal kinases, it reduces off-target effects compared to broad-spectrum inhibitors.
  • Oral efficacy: Optimized for oral administration, providing sustained plasma levels and patient convenience.

Source & Standardization

  • Source: Synthetic chemical synthesis
  • Manufacturing: Multi-step organic synthesis under cGMP conditions
  • Standardization: ≥99.0% purity by HPLC; meets EP/USP monographs
  • Forms: White to off-white crystalline powder; also available as imatinib mesylate
  • Aplicaciones: Generic oncology drugs, research, analytical standards

Quality Specifications (QC Tests)

Test Item Especificaciones
Identificación IR, HPLC retention time conforms to standard
Pérdida por secado ≤0,51 TP3T
Residuo tras la combustión ≤0,11 TP3T
Metales pesados ≤20 ppm
Organic Impurities ≤0.5% total, ≤0.1% individual
Disolventes residuales Meets ICH Q3C limits

Bulk Supply & Documentation

  • Monthly capacity: 500 kg
  • Plazo de entrega: 3-5 días laborables (artículos en stock)
  • Documentación: COA, MSDS, TDS, DMF available upon request
  • Embalaje: 1 kg, 5 kg, 25 kg drums with double LDPE liners

Preguntas frecuentes

What is the minimum order quantity (MOQ) for imatinib?

Our standard MOQ is 1 kg. For research purposes, smaller quantities may be available. Please contact us for specific requirements.

What is the delivery time?

For stock items, delivery is 3-5 business days after order confirmation.

Do you provide a Certificate of Analysis (COA) and samples?

Yes, we provide a COA for each batch. Samples are available upon request for qualified customers.

Contact & Ordering Information

  • Company: LyvBio Co., Ltd.
  • Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
  • Email: info@lyvbio.com
  • Phone: +86-29-65816888

send us your specification for a quotation.

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Room,5-0203, Unit 5, Beiyuanmen Street,Xi'an,Shaanxi,China

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