Finished products

QC of finished products (Ph.Eur. & USP)

• Apparent volume
• Bulk density & tapped density
• Content uniformity
• Disintegration testing
• Dissolution testing (paddles & baskets)
• Friability
• Hardness
• Resistance to crushing of tablets
• Particulate contamination (microscopy)
• Particle size (sieve & microscopy)
• Assays (titrations, HPLC, UPLC)
• Content uniformity
• Fill volume
• Uniformity of mass
• Impurity testing (TLC, HPLC, UPLC-TQD MS, UPLC-QTOF-MS, CE)

Microbiological methods (Ph.Eur. & USP)

• Bioburden, TAMC, TYMC
• Absence of specific micro-organisms
• Preservative efficacy testing
• Microbiological assay of antibiotics
• Endotoxine testing (gel clot, kinetic methods)
• Sterility testing
• Effectivity of cleaning agents
• Particle counting