Quadrant -I (Video)
Calculations pertaining to antibiotics overages
Quadrant - II (Study Material)
1. Calculations pertaining to antibiotics overages
Quadrant - III (Assignments)
1. Calculations pertaining to antibiotics overages
1. An analytical method used to assay an antibiotic's potency has a relative standard deviation (RSD) of 2.0%. The label claim of the antibiotic is 100 mg/mL. 2. A new oral antibiotic suspension has a label claim of 125 mg/5 mL. The company needs to determine the initial overage for manufacturing. 3. Define "overage" in the context of pharmaceutical manufacturing. 4. A new pediatric antibiotic oral solution has a label claim of 150 mg/5 mL. The company needs to establish the initial overage for manufacturing. The following data are available: Shelf Life: 18 months (assume 30.44 days/month for more precision), Minimum Potency at Shelf Life End: Not less than 90% of label claim, Degradation Kinetics: First-order degradation, with a rate constant (k) of 0.007 week−1 (assume 7 days/week). 5. Label claim = 500 mg. Manufacturing process has a σ=10 mg. We want 99.73% of vials to be at or above 95% of label claim (475 mg).