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, IR, CAD, 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 through 2018. We are in full compliance with cGMP regulations.
- Method Development and Validation
- Release and Stability Studies
- Leachables and Extractables
- Genotoxic Impurity (GTI)
- Chiral Separation
- 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
- Full Sample Management Services
Dedication, Quality, Experience.
Find out how Primera does it better.