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 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 or new formulation 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>)
  • Extractables and leachables (USP <1663> and <1664>)  
  • Identification of unknown process impurities/degradation products by UPLC-QToF
  • Compatibility testing with drug delivery systems
  • Customized studies to meet unique project specific research needs

We have experience in analytical testing with wide variety of dosage forms:
  • Oral 
  • Inhalation
  • Parenteral
  • Liposomal drug products
  • Ophthalmic
  • Topical
  • 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 client’s manufacturing site laboratories.
We are FDA registered and inspected and DEA licensed to handle, store and test controlled substances (Schedules I through V).