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ANALYTICAL KNOW HOW
PHV PHARMA 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
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