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Mesilato de Imatinibe 220127-57-1 Mesilato de Imatinibe 220127-57-1

Mesilato de Imatinibe 220127-57-1
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Informação básica do mesilato de Imatinib

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℃—30℃.

Uso de mesilato de imatinibe

  • Um inibidor de tirosina quinase. Altamente específico para BCR-ABL, a enzima associada à leucemia mielóide crônica (LMC) e certas formas de leucemia linfoblástica aguda (LLA)
  • antifúngico equinocandina, ativo contra infecções por Aspergillus e Candida, inibe a síntese da parede celular
  • Anticâncer

COA do mesilato de imatinibe

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

≤1.0%

0.8%

Heavy metals

≤20ppm

10ppm

Melting range

212 – 220℃

214-216℃

Residue on ignition

≤0.1%

0.08%

Particle size

90% < 100 μm

50% < 50 μm

Confirm

Bulk density

NLT 0.4g/ml

0.6g/ml

Chromatographic

purity

Individual impurities: ≤0.2%

Total impurities: ≤0.5%

0.16%

0.32%

Assay

98.5%-102.0% of Imatinib mesylate,

calculated on anhydrous basis.

99.70%



Residual solvents

Ethyl acetate: ≤5000ppm

Confirm

Acetone: ≤5000ppm

Confirm

N,N-Dimethylformamide: ≤880ppm

Confirm

Methanol: ≤3000ppm

Confirm

Dichloromethane: ≤300ppm

Confirm



MORE_DETAIL Mesilato de Imatinibe 220127-57-1

Informação básica do mesilato de Imatinib

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℃—30℃.

Uso de mesilato de imatinibe

  • Um inibidor de tirosina quinase. Altamente específico para BCR-ABL, a enzima associada à leucemia mielóide crônica (LMC) e certas formas de leucemia linfoblástica aguda (LLA)
  • antifúngico equinocandina, ativo contra infecções por Aspergillus e Candida, inibe a síntese da parede celular
  • Anticâncer

COA do mesilato de imatinibe

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

≤1.0%

0.8%

Heavy metals

≤20ppm

10ppm

Melting range

212 – 220℃

214-216℃

Residue on ignition

≤0.1%

0.08%

Particle size

90% < 100 μm

50% < 50 μm

Confirm

Bulk density

NLT 0.4g/ml

0.6g/ml

Chromatographic

purity

Individual impurities: ≤0.2%

Total impurities: ≤0.5%

0.16%

0.32%

Assay

98.5%-102.0% of Imatinib mesylate,

calculated on anhydrous basis.

99.70%



Residual solvents

Ethyl acetate: ≤5000ppm

Confirm

Acetone: ≤5000ppm

Confirm

N,N-Dimethylformamide: ≤880ppm

Confirm

Methanol: ≤3000ppm

Confirm

Dichloromethane: ≤300ppm

Confirm


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