Advancing Efficiency and Reliability in Pharmaceutical Analysis and Quality Control
Publication by James Carriere, Randy Heyler
Ondax Inc. 850 E. Duarte Road, Monrovia, CA 91016
The pharmaceutical industry faces many challenges in drug development, manufacturing, and quality control, considering the consequences of an inappropriate or ineffective drug being consumed by a patient. One primary concern is that many active pharmaceutical ingredients (APIs) exhibit polymorphism, where different forms or molecular structures of a compound can dramatically affect the efficacy, stability and bio-availability of the drug, with potentially devastating effects on patient outcomes. These structural changes are in many cases quite subtle and hard to detect, and may unintentionally occur during various stages of formulation, storage, packaging and handling. Consequently, rapid and reliable identification of polymorphs during the development, manufacturing, and quality assurance process is critical to all pharmaceutical manufacturing companies.
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