State of the
Art Instrumentation

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GC and GC-MS

Pine Lake Laboratories features Agilent GC with FID, MS and NCD detectors. These instruments are used to perform residual solvents (USP <467>), volatile Extractable and Leachables analyses, and product specific volatile impurity methods.

High Resolution Mass Spectrometry

Pine Lake Labs features a Bruker Aurora Impact HD Time-of-Flight Mass Spectrometer (LC-TOF). This is a powerful tool we use to identify non-volatile organic Extractables, unknown degradation products and metabolites. This instrumentation can also be used to determine the molecular weight of oligonucleotides.

ICP-MS

PLL features a Thermo Scientific iCAP Q ICP-MS. This ICP-MS is used for the identification and quantitation of inorganic Extractables and Leachables. The instrument is also used to perform elemental impurities following USP <232> and <233>.

UPLC-MS

PLL features a Water AcQuity UPLC with a SQ Detector 2 single quadrupole mass spectrometer. This instrument is used for the analysis of Leachables and other low level impurities in drug products.

UPLC-MS/MS

Pine Lake features Waters AcQuity UPLC with Xevo TQ-S tandem quadrupole mass spectrometers. These powerful tools are used to quantitate drugs in plasma and other biological tissues. In addition, these instruments can be used to identify metabolites.

HPLC

Pine Lake Laboratories has 13 HPLC’s. All of the HPLCs have UV detectors plus some systems have CAD and fluorescence detectors. These systems routinely run reverse phase, HILIC, ion pairing and normal phase methods.

Charged Aerosol Detector

Pine Lake features Corona Veo charged aerosol detectors (CADs) on two of its HPLC systems. This detector is used for the analysis of lipids plus Leachables and poor UV absorbing impurities in drug products.

Total Organic Carbon

Pine Lake Laboratories features an Sievers M9 TOC analyzer. This instrument is used to determine when an extraction is exhaustive for an aqueous solvent and as a non-specific test for the verification of the cleaning of medical devices.

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