CMC Analytical Testing

Pine Lake Laboratories has a proven track record in developing and validating methods used to insure the quality of active pharmaceutical ingredients (API) and finished drug products. Our experience allows us to adapt validation strategies and assist in testing designs to meet any unique challenges presented by a new drug in development.

Our experience with method development, validation and testing include: -Assay and related substances/degradation products by HPLC-UV

-Residual solvents by GC-FID (USP <467>)

-Elemental Impurities by ICP-MS (<USP 233>)

-Extractable and Leachable studies

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

Pine Lake Laboratories is an FDA registered and inspected DEA licensed to handle, store, and test controlled substances (Schedule 1 through V).

Analytical Instruments

-HPLC-UV

-ICP-MS

-GC-FID

-UPLC

-QToF

Capabilities:

-Oral

-Parental

-Liposomal

-Drug products

-Opthamalic

-Topicals

-Transdermal

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

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