Combination Product Testing
Pine Lake Laboratories has a proven track record in developing and validating methods used to insure the quality of combination devices, especially combination pharmaceutical medical devices. Our experience allows us to adapt validation strategies and assist in testing designs to meet the unique challenges of combination devices.
Our experience with methods for combination products includes:
- Assay and 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
- Extractables and leachables studies
- Identification of unknown process impurities/degradation products by UPLC-QToF
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.
All work performed in compliance with FDA GMP.