Product Summary
Brigatinib CAS 1197953-54-0 | High Purity Antineoplastic API SupplierPremium Brigatinib (CAS 1197953-54-0) with ≥99.5% HPLC purity, custom formulation available. Professional GMP-compliant supplier of Brigatinib API (AP26113/Alunbrig) for non-small cell lung cancer (NSCLC) treatment R&D, oncology ...
High purity API powder Brigatinib CAS 1197953-54-0 from GMP factory
Basic Properties
Trading Properties
Brigatinib API powder
,high purity Brigatinib
,GMP factory API powder
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Brigatinib CAS 1197953-54-0 | High Purity Antineoplastic API SupplierPremium Brigatinib (CAS 1197953-54-0) with ≥99.5% HPLC purity, custom formulation available. Professional GMP-compliant supplier of Brigatinib API (AP26113/Alunbrig) for non-small cell lung cancer (NSCLC) treatment R&D, oncology research, and pharmaceutical production. Bulk stock, fast global shipping, full regulatory documentation support with COA provided
Test Item Standard Limit Customization Available Purity (HPLC) ≥99.5% 99.0% / 99.8% / 99.9% Single Impurity ≤0.2% ≤0.1% Total Impurities ≤0.5% ≤0.3% Loss on Drying ≤0.5% Custom Residue on Ignition ≤0.1% Custom Heavy Metals ≤10 ppm ≤5 ppm Arsenic ≤2 ppm ≤1 ppm Residual Solvents Meets ICH Q3C Guidelines Custom Endotoxin Level ≤0.5 EU/mg ≤0.25 EU/mg Sterility Sterile (for injection grade) Custom Particle Size D90 ≤ 100μm Custom (micronized / nanonized) Storage Condition 2-8°C sealed, dry, light-proof, away from oxidizing agents - Shelf Life 24 months under standard storage - - Full Batch Quality Control: Every batch undergoes strict HPLC, mass spectrometry, elemental analysis, water content testing, heavy metal testing, residual solvent testing, and endotoxin testing before shipment
- Certificate of Analysis (COA): Detailed COA provided with every order, including all test results, batch information, production date, expiration date, and quality control signature
- Regulatory Compliance: Manufactured in strict accordance with GMP and ICH guidelines, with full support for DMF filing, CTD documentation, and other regulatory requirements in the US, EU, Japan, and other global markets
- Quality Guarantee: Free replacement or full refund for any product quality issues confirmed by our quality control team and third-party testing institutions
- Continuous Quality Improvement: We regularly update our production processes and quality control standards to ensure our products meet the latest international pharmaceutical quality standard

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