Analytical Testing of Combination Products

Pine Lake Laboratories has a proven track record in developing and validating methods used to insure the quality of combination devices.

Our experience allows us to adapt validation strategies and assist in testing designs to meet the unique challenges of combination devices.

Methods for Combination Products include:

-Assay related substances/degradation products by HPLC-UV

-Residual process solvents by GC-FID

-Drug release/elution by HPLC-UV

-Uniformity of coating by HPLC-UV

-Extractable and Leachable studies

-Identification of unknown process impurities/degradation products by UPLC-QToF

Analytical Instruments

-HPLC-UV

-GC-FID

-UPLC

-QToF

Capabilities:

We have the capacity to perform routine analyses once the methods are validated and can assist in investigations of unexpected results. We have also transferred methods to clients manufacturing site laboratories.

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