Quality Control Tests for Parenteral Products ensure product safety, sterility, and compliance.
Quality Control Tests for Parenteral Products include sterility, pyrogen, particulate matter, pH, clarity, and leakage tests for reliable therapeutic use.
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.
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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:
- 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.
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