ICH Q3A/Q3B guidance documents define impurities as either organic, inorganic, or residual solvents. Organic impurities can develop from degradation or in thechemistry process. Inorganic impurities can come from reagents or catalysts, salts, or excipients. Residual solvents in drug substance or product may come from any step in a chemistry or manufacturing process. And any of these may come from packaging, labeling, shipping, or other exposure to external contaminants.
Averica has built much of its reputation around identifying and often isolating pharmaceutical impurities. Our capabilities support many impurity related tasks:
- Stress degradation to understand degradation chemistry
- HPLC-MS profiling, including accurate mass MS/MS, for organic structure
- Isolation and purification of organic impurities
- Inorganics profiling and quantitative analysis using ICP-MS and AA
- Particle sizing, microscopy, and particle counting
- Residual solvent testing
- Extractables profiling and leachables testing
- Excipient analysis and drug product specification development
We have designed our laboratories to provide comprehensive impurity support for CMC specialists and product development teams from preclinical to commercial stages of development.
Solutions for Your Impurity Challenges
Confirm the structure of impurities or conduct pharmacologic or toxicologic studies on impurities, by rapid characterization using multiple approaches. We offer:
- UPLC-MS/MS with accurate mass for structural characterization of organic impurities.
- GC/MS/FID for volatile impurities.
- UPLC-diode array UV or CAD detection for characterization of chromophore and response factor.
- ICP-MS for profiling metal impurities.
Averica is unique in our approach to impurity isolation, in that we use our scalable separation expertise to isolate significant amounts of unknown chemical impurities. This may mean isolating 10 mg of a trace potential genotoxic contaminant – sufficient for full characterization by NMR. Or it may mean isolating grams of a 0.1% impurity from bulk drug for use as a reference standard. In every case, we offer you more material; and that means more utility.
Averica’s Targeted Isolation™ has been a remarkably successful program supporting both drug substance and drug product development. Whether solving problems during clinical development, completing CMC filings, or improving GMP synthesis, Averica’s impurity isolation is a proven strategy for reducing development cost and time.
- Structure Elucidation
- Forced Degradation
- Stability Testing
- Reference Standards
- Toxicology Studies
- SFC – Preparative & Analytical
- HPLC – Preparative & Analytical
- RP LC – Preparative & Analytical
- CAD Detection
- Accurate Mass MS
The Averica Advantage
- Trace component isolation as low as 0.01% of bulk
- Batch scale chromatography for fast isolation from feedstock
- Degradation kinetics—Understand Formation, Purge and Fate
- Drug substance or drug product—Solid, liquid, and semi-solid dosage forms
- Method development and optimization
- Fast timelines