AMPAC Analytical has extensive experience in the validation and transfer of methodology to support pharmaceutical testing for all phases of products. Our team will work with you in determining phase appropriate validations to support product development. We work with a variety of LCs and GCs to validate methods for assay/purity/impurity determinations. AMPAC Analytical can draft the necessary validation protocols and reports to support your regulatory and filing needs.

Typical Validation Properties

  • Specificity
  • Linearity
  • Limit of Detection/Limit of Quantitation
  • Accuracy
  • Precision
  • Ranging Studies
  • Intermediate Precision
  • Robustness Studies
  • Forced Degradation Studies

We also have significant experience in the validation of GC methods to support purity/impurity/residual solvents testing as well as considerable experience in the development of Chiral methods for compounds that are chirally active and thermally stable. We can also develop Ion Chromatography (IC) methods to support testing of counter-ions or for the determination of residual salts.AMPAC Analytical validates methods for Elemental Impurities to comply with upcoming regulations from USP<232> and USP<233> and ICH Q3D. We have extensive experience with the development of robust sample preparation (digestion) procedures to support testing of a variety of drug substances, drug products and excipients.

Method Transfers

Upon completion of validations, our laboratory can support your needs in transferring methods to your manufacturing or other external testing sites. AMPAC Analytical can draft the necessary transfer protocols and reports to support your regulatory and filing needs.