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      Basic information of Imatinib Mesylate

      Name

      Imatinib Mesylate

      Alias

      GLIVEC;GLEEVEC;IMATINIB METHANESULFONATE; CGP-57148B; 
      4-[(4-methylpiperazin-1-yl)methyl]-N-[4-methyl-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]-phenyl]-benzamide Mesylate;

      CAS NO.

      220127-57-1

      Molecular Formula

      C30H35N7O4S

      Molecular Weight

      589.71

      Quality Standard

      In-house Standard

      Package Size

      Aluminium bag; 50g/bag; 100g/bag

      Brief Introduction

      Imatinib mesylate (also called Gleevec) is a small-molecule inhibitor of the fusion protein Bcr-Abl, 
      the causal agent in chronic myelogenous leukemia.
      As an inhibitor of PDGFR, imatinib mesylate appears to have utility in the treatment of a variety of 
      dermatological diseases. Imatinib has been reported to be an effective treatment for 
      FIP1L1-PDGFRalpha+ mast cell disease, hypereosinophilic syndrome, and dermatofibrosarcoma protuberans.

      Storage condition

      Preserve in tight, light-resistant containers, and store at 15¡æ¡ª30¡æ.

      Use of Imatinib Mesylate

      • A tyrosine kinase inhibitor. Highly specific for BCR-ABL, the enzyme associated with chronic myelogenous leukemia (CML) and certain forms of acute lymphoblastic leukemia (ALL)
      • echinocandin antifungal, active against infections with Aspergillus and Candida, inhibits cell wall synthesis
      • Anticancer

      COA of Imatinib Mesylate

      TEST ITEM

      SPECIFICATION

      RESULTS

      Appearance

      White or slightly yellow crystalline powder, 
      homogeneous and with fine grain size. 
      No foreign particles are observed.

      Slightly yellow crystalline Powder

      Solubility

      Soluble in water and in acids solutions, slightly soluble 
      in methanol insoluble in acetone, acetonitrile and 
      dilute hydroxyl alkaline solution

      Confirm

      Identification

      Complies

      Confirm

      Water

      ¡Ü1.0%

      0.8%

      Heavy metals

      ¡Ü20ppm

      10ppm

      Melting range

      212 ¨C 220¡æ

      214-216¡æ

      Residue on ignition

      ¡Ü0.1%

      0.08%

      Particle size

      90% < 100 ¦Ìm

      50% < 50 ¦Ìm

      Confirm

      Bulk density

      NLT 0.4g/ml

      0.6g/ml

      Chromatographic

      purity

      Individual impurities: ¡Ü0.2%

      Total impurities: ¡Ü0.5%

      0.16%

      0.32%

      Assay

      98.5%-102.0% of Imatinib mesylate,

      calculated on anhydrous basis.

      99.70%



      Residual solvents

      Ethyl acetate: ¡Ü5000ppm

      Confirm

      Acetone: ¡Ü5000ppm

      Confirm

      N,N-Dimethylformamide: ¡Ü880ppm

      Confirm

      Methanol: ¡Ü3000ppm

      Confirm

      Dichloromethane: ¡Ü300ppm

      Confirm

      ±¸×¢£ºÒÔÉϲúÆ·½öÓÃÓÚ¿ÆÑС£¡£ ¡£¡£ ¡£¡£¡£
      Copyright(C)2018, Sichuan Jisheng Biopharmaceutical Co.,Ltd All Rights Reserved. 97¹ú¼Ê °æÈ¨ËùÓРÊñICP±¸2020026170ºÅ-1 
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