Pharmaceutical impurities
Averica has built much of its reputation around identifying and often isolating pharmaceutical impurities
We have designed our laboratories to provide comprehensive impurity support for CMC specialists and product development teams from preclinical to commercial stages of development.
ICH Q3A/Q3B guidance documents define impurities as either organic, inorganic, or residual solvents. Organic impurities can develop from degradation or in the chemistry 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.
Our capabilities support many impurity related tasks:
- Stress degradation to understand degradation chemistry
- Residual solvent testing
- Isolation and purification of organic impurities
- Particle sizing, microscopy, and particle counting
- Inorganics profiling and quantitative analysis using ICP-MS and AA
- HPLC-MS profiling, including accurate mass MS/MS, for organic structure
- Extractables profiling and leachables testing
- Excipient analysis and drug product specification development
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
Solutions for your Impurity challenges
Impurity Profiling & Characterization
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.
Impurity Isolation
At Averica, we have a unique approach to impurity isolation, utilizing our scalable separation expertise to isolate significant amounts of unknown chemical impurities. For example, we can isolate 10 mg of a trace potential genotoxic contaminant, which is sufficient for a complete characterization by NMR. Alternatively, it may mean isolating grams of a 0.1% impurity from a bulk drug to use as a reference standard. In any case, we offer more material, which provides 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 costs and time.
APPLICATIONS
- Structure Elucidation
- Forced Degradation
- Stability Testing
- Reference Standards
- Toxicology Studies
Instrument and Detective Systems
- SFC – Preparative & Analytical
- HPLC – Preparative & Analytical
- RP LC – Preparative & Analytical
- UPC^2
- UPLC
- GC
- ELSD
- MS
- CAD Detection
- PDA/UV
- NMR
- Accurate Mass MS