Test dimensions | Description | Medicine analytical technology | Role in a MQSS | Costa |
---|---|---|---|---|
Identity | Verifies identity of SAPI | Visual examination of packaging Counterfeit detection device (CD3) RAMAN spectroscopy (hand-held device) Specialized mass spectrometry (MS) techniques Direct analysis in real time (DART) Desorption electrospray ionization—(DESI) | Screening Screening Screening Confirmatory | n/a * ** *** |
Assay | Detection and quantitation of SAPI | Semi-quantitative thin layer chromatography (TLC) (GPHF MiniLab®) High performance liquid chromatography (HPLC) and coupled to mass spectrometer (LC–MS) Mass spectroscopy (MS) | Screening Confirmatory Confirmatory | * ** *** |
Disintegration | Determines that a tablet or capsule will disintegrate | GPHF MiniLab® | Screening | * |
Dissolution | Proxy measure of the bioavailability of a medicine (extent to which medicine will dissolve in the body) | Dissolution apparatus | Confirmatory | ** |