Afatinib Dimaleate

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GRAND WUYAO (JIANGSU) PHARMACEUTICAL CO., LTD

Business Type:Manufacturer

Country/Region:China

Ddu Verified

HOT Rank

8/10

Product Information

  • Active Ingredients:Afatinib Dimaleate
  • Chemical Formula:C₂₄H₂₇FN₄O₇·C₄H₄O₄
  • Molecular Weight:642.61
  • Pharmacopeia:EP
  • Package Type:1kg
  • Shelf Life:2 years
  • Storage:Protected from light
  • Place of Origin:China

Description

1. Basic Identification
  • English Name: Afatinib Dimaleate API
  • CAS Number: 850140-73-7
  • Molecular Formula: C₂₄H₂₇FN₄O₇·C₄H₄O₄
  • Molecular Weight: 642.61 g/mol (combined with maleic acid)


2. Physical Properties
  • Appearance: White to off-white crystalline powder
  • Solubility: Soluble in water and methanol; slightly soluble in ethanol
  • Storage: Store at 2-8°C, protected from light and moisture in airtight containers


3. Pharmaceutical Uses
  • Indications: Treatment of non-small cell lung cancer (NSCLC) with EGFR mutations.
  • Mechanism: Reversible tyrosine kinase inhibitor targeting EGFR (HER1), HER2, and HER4.
  • Route: Oral administration (tablets, as the maleate salt form).


4. Quality Standards
  • Pharmacopoeias: USP, EP, ChP (where applicable)
  • Key Specs:
    • Purity ≥99.0% (HPLC)
    • Related substances ≤0.5% (individual impurity limits)
    • Residual solvents compliant with ICH guidelines
    • Maleic acid ratio: Consistent with stoichiometric composition


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