Impurity Isolation & Identification
Customized Impurity Isolation & Identification Services: Partnering with You for Success
Novatia has been a trusted partner of both innovator and generic pharmaceutical companies for over two decades, providing both drug substance (DS) impurity and drug product (DP) degradant isolation and identification services. We understand that each product is unique and comes with its own challenges and regulatory requirements. With our understanding of ICH guidelines pertaining to drug impurities and degradants, our capabilities in applying common separation (normal phase flash chromatography and reverse phase HPLC) and spectroscopic (MS and NMR) techniques, and our knowledge of organic chemistry principles, Novatia has an advantage in isolating and identifying even the most difficult DS impurities or DP degradants.
Our Expertise:
- Rapid structural profiling using LC/UV/MSn or GC/MS to quickly survey a sample and obtain accurate mass and substructural information on relevant components in a sample.
- Developing forced degradation conditions to enhance levels of target impurities and streamline their isolation
- Targeted component isolation using our chromatographic capabilities to enable detailed structural characterization by MSn ion mapping and NMR analysis.
- Detailed structure analysis using MSn ion mapping for rapid identification and localization of modifications to parent structure and/or high sensitivity NMR spectroscopy to obtain 1D and 2D homo and heteronuclear NMR data for detailed structural characterization on as little as 50 µg of sample.
- Expert chemists specializing in MS, NMR, and organic chemistry with many years of experience in the pharmaceutical industry.
Why Choose Novatia?
- We own projects: understanding client goals to ensure needs are met
- We design efficient studies: ensuring that only and all relevant data is collected
- We have a proven track record: partnering to meet client needs for 25 years
- We focus on communication: prioritizing client understanding of studies and results
Get In Touch:
If you’re looking for a partner who will work with you to design and execute effective impurity isolation and identification studies that meet regulatory agency requirements, contact us today. Our team is ready to collaborate with you to ensure the success of your pharmaceutical product.
