Agility and accuracy: extensive facilities equipped with the latest technology coupled with a team of top professionals.
Pharmaceutical equivalence
Full and partial validation of dissolution.
Partial and total validation of related substances, content uniformity - included forced Degradation test in addition to specificity (samples under acid, alkaline, oxidative, thermal and photolytic stress conditions).
Comparative dissolution profile
Biowaiver | RDC 37/2011
Solubility and dissolution profiles in three valid media.
Dissolution Development| RDC 31/2010
Solubility - quantitative assessment of the active substance in the physiological pH range.
Definition of the most appropriate parameters to the active substance of the dosage form in the study - the dissolution medium, apparatus, rotation, surfactant need (when applicable), the need to anchor (when applicable), filtration and deaeration.
Development of analytical methods for content and dissolution quantification
Development of analytical methods for cosmetic products
Osmolarity Test
Quality control of medicines and cosmetics
Main Equipment:
Shaker flask • Dissolutors apparatus I, II, III and IV • Analytical balance and microanalytical • Viscometer HPLC with UV detectors, FLD and DJD - UHPLC • Disintegrator • Osmometer • Microscope with Incident illumination and oblique durometer • Spectrophotometers UV / Vis, FTIR • Friabilometers