Illustration PHV Pharma

 

ANALYTICAL KNOW HOW

 

PHV offers a complete, fast-turnaround analytical development service to provide the most accurate solution to your needs.

Development and validation of physicochemical and chromatographic methods:
•    stability-indicating dosage methods for active substances and preservatives
•    detection of degradation products, synthesis impurities and residual solvents
•    discriminatory dissolution testing

Stability studies (ICH)

•    forced degradation studies
•    studies under long-term, intermediate and accelerated conditions
•    container / content interaction studies
•    marketing monitoring (on-going stability)


We also offer the following studies in partnership with the University:


•    identification of impurities and degradation products using LC-MS/MS
•    structural analysis using two-dimensional NMR and mass spectrometry
•    polymorphism detection using DSC, XR, ATG
•    multielement dosing using ICP/MS

Impurities profile

•    identification of impurities and degradation products
•    genotoxic impurity limit tests
•    metal detection
•    preparation of reference compounds