Physical Tests:
Particulate Matter Test: Detects visible and sub-visible particles using light obscuration or microscopy.
Leakage Test: Ensures container integrity via dye ingress, vacuum, or pressure methods.
Volume/Fill Test: Verifies fill volume within pharmacopeial limits.
Clarity Test: Ensures solution is free from turbidity and visible particles.
Chemical Tests:
pH Measurement: Confirms pH within the specified range.
Drug Content and Assay: Verifies active ingredient concentration via HPLC or UV spectroscopy.
Stability Testing: Assesses chemical, physical, and microbiological stability under accelerated and real-time conditions.
Microbiological Tests: (Quality Control)
Sterility Test: Confirms absence of microorganisms via direct inoculation or membrane filtration.
Pyrogen Testing: Detects fever-inducing substances.
Rabbit Test: Measures temperature rise in rabbits.
LAL Test: Detects bacterial endotoxins.
Antimicrobial Effectiveness Test: Ensures preservative efficacy in multi-dose formulations.
Container-Closure Integrity Test: Validates seal sterility using vacuum decay or dye penetration.
Biological Tests: For vaccines and biologics, confirms efficacy and safety.