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Study Guide 2019-20

DPHA_B03 Applied pharmaceutical analysis and characterization of pharmaceutical formulations PDF Print

Instructors: Ch. Kontoyannis, Μ. Orkoula

Co-ordinator: Ch. Kontoyannis

Content:

Validation of analytical methods; Τhe concept of traceability; GLP and GMP in Pharmaceutical industry; Process Analytical Technology (PAT) and pharmaceutical industry; Stability studies of formulations and active pharmaceutical ingredients (API).
Physical characterization of APIs and formulations: Determination of refractive index: Principles, instrumentation, applications; Viscosity of creams and semisolid formulation; Polarimetry: Principles, instrumentation, applications; Particle size distribution: Principles, instrumentation, applications; Thermal analysis methods (TGA, DTA, DSC); Porosity measurements (BET); Karl Fischer titration; microscopy (optical and SEM).
Polymorphism of API in Formulations: NIR, ATR, IR-ATR, Raman, XRPD, DSC-TGA, microscopy (optical and SEM): Case studies.
Elemental analysis (XRF, AAS, AES, ICP-MS, ICP-OES).