Extractables and Leachables

Pine Lake Laboratories is the scientific leader in extractables and leachables studies. We have extensive experience with pharmaceutical container closures, single use system components, and combination devices.

Our experienced scientific staff utilizes the following analytical methods for experts identification of extractables observed in a forced extraction study:

-Headspace GC-MS for identification of volatile organic extractables

-GC-MS for identification of semi-volatile organic extractables

-LC-QToF for identification of non-volatile organic extractables

-ICP-MS for identification of inorganic extractables

-Polynuclear Aromatic Hydrocarbon Screening (GC-MS)

-Nitrosamine analysis by GC-NCD

-Exhaustive Extraction Determination

Drug Product Compatibility Testing Pine Lake Laboratories has extensive experience designing and executing studies to evaluate the compatibility of infusion sets and pumps with the drug products to be delivered. Studies are custom designed for the intended use and can use compendia analytical methods or analytical methods or analytical methods transferred from the client to evaluate drug recovery and stability.

Analytical Instruments

-GC -MS

-LC -QToF

-ICP-MS

-LC-MS

Capabilities:

-Orally inhaled and nasal drug products

-Parenterals -Prefilled Syringes

-Opthamalic

-Topicals

-Transdermal

-Implantable medical devices (mesh products)

-Combination medical devices (drug coated stents, ocular implants)

-Infusion set pumps

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