Analytical and Stability Services (ANA) (Small Molecules)

Primera specializes in customized analytical method development, transfer, and validation using state-of-the-art analytical tools such as HPLC (with UV, CAD, RI, ELSD, FLD, and conductivity detectors), UPLC, Ion Chromatograph, LC-MS/MS, GC, ICP-MS, and GC-MS, etc.

We also provide cGMP sample storage and testing services. Primera understands the unique needs of our customers and our extensive experience allows us to provide high quality and fast turnaround times.

We are registered with the FDA and have had multiple successful GLP and GMP audits. We are in full compliance with cGMP regulations and offer services such as:

  • Method Development, Transfer and Validation
  • Release and Stability Studies
  • Extractables and Leachables
  • Genotoxic Impurity (GTI) including nitrosamines
  • Chiral Separation
  • Inpurity Isolation utilizing prep-HPLC
  • Drug Substance Impurity Profiles
  • Impurity Identification of Stability Samples
  • Coulometric and Volumetric Karl Fischer Testing
  • Elemental Impurity Analysis by ICP/MS
  • Polymer Analysis
  • Residual Solvents
  • Polymorph analysis by XRPD
  • Particle Size Distribution
  • Cleaning Validation
  • Raw Materials Testing
  • Transdermal Patch Physical Testing
  • Full Sample Management Services

Dedication, Quality, Experience.

Find out how Primera does it better.