Imatinib Mesylate- GRAND WUYAO (JIANGSU) PHARMACEUTICAL CO., LTD

GRAND WUYAO (JIANGSU) PHARMACEUTICAL CO., LTD

Business Type:Manufacturer

Country/Region:China

Ddu Verified

HOT Rank

6/10

Basic Information

Structural Characteristics

Chemical Structure: A tyrosine kinase inhibitor (TKI), containing a phenylaminopyrimidine core structure with a methylsulfonate (mesylate) salt group.
Mechanism of Action: Selectively inhibits BCR-ABL tyrosine kinase (implicated in chronic myeloid leukemia, CML), c-KIT (gastrointestinal stromal tumors, GIST), and PDGFR (platelet-derived growth factor receptor).

Pharmacological Properties

Therapeutic Use:
- Indicated for:
  - Chronic myeloid leukemia (CML) at all stages (chronic, accelerated, blast phase).
  - Gastrointestinal stromal tumors (GIST) unresectable or metastatic.
  - Other rare malignancies (e.g., dermatofibrosarcoma protuberans, acute lymphoblastic leukemia).
Route of Administration: Oral administration (tablets/capsules).
Pharmacokinetics:
- Well-absorbed, with peak plasma concentration reached in 2–4 hours.
- Metabolized in the liver via CYP3A4; the mesylate salt enhances water solubility.
- Excreted primarily in feces (68%) and urine (13%).

Standards and Specifications

Pharmacopoeia Compliance: Meets USP, EP, ChP, and other major pharmacopoeial standards.
Key Quality Indicators:
- Purity: ≥99.0% (HPLC).
- Related Substances: Strict limits for impurities (e.g., imatinib free base, N-demethylated metabolites).
- Residual Solvents (e.g., methanol, acetonitrile), Heavy Metals, Moisture Content, and Microbiological Tests.

Storage and Handling

Storage Conditions: Store in a dry, cool place (2–8°C or as specified), protected from light and moisture.