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ANALYSIS OF EXTRACTABLES AND LEACHABLES

June 8, 2017

Manufacturers of pharmaceuticals, drug delivery systems, and biomedical devices have come under growing pressure to perform sensitive and accurate analytical studies to detect, identify, and quantify extractable and leachable compounds (E&Ls). E&Ls may be inherently toxic or may contaminate or interact with drug products, posing a potential danger to patients. Even as regulatory guidance related to the application, performance, and reporting of E&L studies increases and examples and data accumulate, E&L analysis is still an evolving area of investigation.

Spotlight

Norton Sound Health Corporation

Norton Sound Health Corporation (NSHC) is a tribally owned and operated, independent, not-for-profit health care organization. NSHC operates the Norton Sound Regional Hospital in Nome and clinics in the 15 villages within the 44,000 square miles that comprise the Bering Strait region. NSHC was established in 1970 to meet the health care needs of the Bering Strait region’s Inupiaq, Siberian Yupik and Yup’ik people. Its mission is to provide quality health services and promote wellness within our people and environment. NSHC employs a wide variety of health care professionals including Physicians, Nurses, Dentists, Optometrists, Pharmacists, Physical Therapists, Medical Technologists, Paramedics, Behavioral and Mental Health Professionals.

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