Alectinib Hydrochloride

Alectinib Hydrochloride (CAS 1256589-74-8)
Second-Generation ALK Inhibitor API for NSCLC Therapy

Key Attributes:

• Purity: ≥99.6% (HPLC)

• Formula: C₃₀H₃₄N₄O₂·HCl

• Crystal Form: Polymorph B (Thermodynamically Stable)

• Residual Solvents: <ICH Q3C Limits

Critical Quality Parameters:
✓ Chiral Purity: >99.9% enantiomeric excess
✓ Particle Size: D90 <50μm (Jet Milled)
✓ Water Content: <0.15% (KF)
✓ Heavy Metals: <10ppm Total

Primary Applications:
• ALK+ NSCLC first-line treatment
• Crizotinib-resistant mutation therapy
• Brain metastasis management
• Pediatric ALCL off-label use (clinical trials)

Manufacturing Excellence:

• FDA Inspected cGMP Facility

• USDMF Type II Available (#284756)

• ICH Stability Data: 36M @25°C/60%RH

• REACH Compliant Synthesis

Packaging:
1kg Aluminum Foil Bags (Double PE Lined)
5kg Stainless Steel Containers

Competitive Advantages:

1. Validated Delumping Process (Free-flow API)

2. ROS/Genotoxicity Study Package Available

3. Customized Salt Forms Development Service

4. Global IND/NDA Documentation Support