Rodney L. Parsons

Process Research and Development for a Tetrazole-Based Growth Hormone Secretagogue (GHS) Pharmaceutical Development Candidate

BMS-317180 (1) is a potent, orally active agonist of the human growth hormone secretagogue (GHS) receptor. This manuscript details the process research and development efforts that enabled the synthesis of the phosphate salt of 1 on a multi-kilogram scale. Key considerations in the development of this process focused on safe execution and the requirement for telescoped synthetic transformations (i.e., without isolation of intermediate products) to contend with a lack of suitably crystalline products.

Analytical Considerations for Genotoxic and Other Impurities

Abstract Recent regulatory guidelines for the control of genotoxic impurities in pharmaceutical products have posed a significant challenge for the pharmaceutical industry. This chapter provides an overview of the regulatory requirements, evolution of the established exposure limits, assessment of genotoxic impurities, and the implementation and execution of an appropriate risk-based genotoxic control strategy. In addition, an overview of the analytical challenges, methodologies, and strategy for testing genotoxic impurities at trace levels in pharmaceutical products is provided.