Impurity Qualification Strategy
Managing Safety Risks in Your Drug Substance
Overview
Impurities are inevitable, but their risk must be managed. We guide you through the complex landscape of ICH Q3A/B/C/D guidelines to identify, control, and qualify impurities, degradants, and residual solvents. We help you design the right toxicology studies to justify specification limits.
Key Features
Our Process
Risk Identification
Screening your process for potential impurities and degradants.
Toxicological Evaluation
Comparing levels against safety thresholds (TTC, PDE).
Control Strategy
Implementing process controls or testing to keep levels safe.
Frequently Asked Questions
Why Choose Us
- Patient safety assurance
- Regulatory acceptance of specifications
- Avoidance of clinical holds
- Clear control strategy
Get More Details
Request a personalized consultation and detailed information about this service.
We'll respond within 24 hours
Ready to get started?
Contact our team to discuss your specific needs for Impurity Qualification.
Schedule ConsultationWhat Our Clients Say
"An unexpected impurity appeared in our pivotal batches at 0.12%. Adelphi found published safety data that qualified it without delaying our NDA. That saved us 6 months and $500K in tox studies."
Dr. Lisa Park
Development Chemist
Specialty Pharma
Related Services
Explore other ways we can support your regulatory needs
Module 3 Authorship & Review
Comprehensive writing and critical review of CTD Module 3 (Quality).
GMP Compliance Audits
Mock inspections and gap analyses to ensure inspection readiness.
21 CFR Part 11 Compliance
Validation and documentation support for electronic records and signatures.