Analytical Development

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 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" .

Stability Studies

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.

Forced Degradation

Regis offers forced degradation studies from its Analytical Development team.

Watch a technical seminar on forced degradation given by Paul Wrezel, Ph.D.

Analytical Development Strategies

Analytical Development Resources

Click the video on the left to view this technical seminar given by Paul Wrezel, Ph.D.

Click here to read a paper on the "System Suitability and Validation for Chiral Purity Assays of Drug Substances." In this paper written by three members of the Regis Analytical Development and Quality Assurance teams, they detail the following:

Measurement of chiral purity is a necessary means of quality control for drug substances that exhibit chiral centers. This paper will describe a simple and practical approach to setting up system suitability and validation for chiral purity assays.

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