Impurity isolation and identification offers you critical information on the structure of your impurity, triggering synthesis efforts that contribute directly to CMC filings and better defining conditions for the GMP synthesis process.
Preparative Scale Impurity Isolation Applications:
- Structure Elucidation
- Reference Standards
- Toxicology Studies
Averica’s focus in this area is in preparative chromatography. We aim to give you enough impurity material to get a definitive structure. This enhances your ability to understand the formation and determine the fate of the impurity. At the same time, we aim to create methods that easily scale up and can deliver material for reference standards or toxicology studies. Our ability to deliver you valuable information about your impurity profile and pure material for studies, speeds candidate development from IND-enabling studies to NDA.
Instrument & Detection Systems:
- SFC – Preparative & Analytical
- HPLC – Preparative & Analytical
- RP LC – Preparative & Analytical
- CAD Detection
- Accurate Mass MS
Our Targeted Isolation™ Process
Averica’s Targeted Isolation™ process rapidly develops a unique isolation strategy for each impurity. Impurity isolation and characterization begins with an exchange of data, knowledge, and methods so that a project can move quickly to isolation work.
Our scientists develop methods to enrich and finally purify each peak of interest, rotating between preparative chromatography and analysis and isolation in a pattern uniquely designed for each target peak. Isolation of milligrams of pure compound – even when dealing with a 0.01% trace impurity – is often possible.
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.
The Averica Advantage
- Trace component isolation 0.01% of bulk
- Batch scale chromatography to 1 kg
- 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