Analytical Analysis of Combination Products

Pine Lake Laboratories has a proven track record in developing and validating analytical methods used to insure the quality of the pharmaceutical and biological components of combination products.

Our experience allows us to adapt validation studies and testing strategies to meet the unique challenges faced by pharmaceuticals when placed into combination products.

Services include:

- Development and validation of assay/related substances/degradation products methods by HPLC-UV
- Development and validation of method for residual process solvents by GC-FID
- In Vitro drug elution
- Uniformity of coating determination
- Identification of unknown process impurities/degradation products by UPLC-QToF
- Extractable and Leachable studies

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 client’s manufacturing site laboratory. All work performed is FDA GMP compliant.