ImpurID™ Services

Reassuring technology to identify, quantify and qualify unknown impurities.

hy risk discovering an impurity or degradation of product? The last thing you want is a delay in the development process or possibly having your product removed from the market. Our world-class ImpurID™ Services team is expertly trained to quickly respond and resolve impurity issues.

Our team includes PhDs in analytical chemistry, synthetic organic chemistry and mass spectrometry who have years of academic and industrial experience in compound isolation, purification and identification, as well as small and large molecule structure elucidation and synthesis. Once the team identifies the unknown material, the mechanism of its origin can be determined, and reference standards can be synthesized. In addition to our technical expertise, we can help navigate the regulatory pathway to determine the best identification and qualification strategy, both domestic and international. We also provide guidance on the requirements/study design and prepare samples for toxicity evaluation, if warranted.

One 2 One ImpurID™ Services is your total impurity solution.

These detailed impurity identification downloads are available:

Structure Elucidation  Root Cause  Regulatory Guidance



View ImpurID™ Technical Notes ImpurID™ Services in print:

1. McGinley, C.M.; Loe, O.; Zhu, Z.; Bigwarfe Jr., P.M. “Managing Impurities and Degradation Products” Contract Pharma, 2007, (5), 6-10.
2. Bigwarfe Jr., P.M. “Impurity Identification and Qualification Services” BioProcess International, 2007, 5, (7), 52.
3. McGinley, C.M.; Zhu, Z.; Levine, B.S..; Bigwarfe Jr., P.M. “Managing Pharmaceutical Impurities and Degradation Products” Pharmaceutical Canada, 2008, 9, (1), 6-11.
Contact our scientists to discuss getting your development program moving again.