Regis is a premier custom small molecule manufacturer with state-of-the-art analytical support services. Our Analytical Development team consists of highly skilled analytical chemists talented in developing and validating phase appropriate methods. Let Regis help support your analytical requirements from preclinical R&D through clinical development, and into commercial manufacturing. Regis' analytical capabilities are also available to clients requiring standalone pharmaceutical services.
Impurity Services and Structure Elucidation
Impurity levels need to be understood and controlled for the benefit of safely administering pharmaceutical products to humans. Impurities impact not only the safety of drugs, but also the development time if not addressed early during the API scale up process. Learn about elemental impurities and the new ICH Q3D and USP <232> and <233> guidelines here.
Regis offers services for impurity isolation, identification, structure elucidation and characterization along with synthesis and qualification of reference standards.
Watch the video to learn more about the "Structure Elucidation of Impurities in Drug Substance by 2D NMR" .
Regis offers forced degradation studies from its Analytical Development team.
Watch a technical seminar on forced degradation given by Paul Wrezel, Ph.D.
The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. Stability studies test those attributes of the drug substance that are susceptible to change during storage and are likely to influence quality, safety, and efficacy. The testing includes as appropriate, the physical and chemical attributes.
Analytical Development Resources
Watch a technical seminar on Analytical Development Strategies, presented by Paul Wrezel, Ph.D. on
Click here to read a paper on the "System Suitability and Validation for Chiral Purity Assays of Drug Substances". This paper outlines a practical approach to the measurement of chiral purity as a necessary means of quality control for drug substances that exhibit chiral centers, and describes a simple and practical approach to setting up system suitability and validation for chiral purity assays.