Tuesday, October 30, 2012

Pharmaceutical Quality Control Calculations A1

Problem A1

Theoretical weight of 10 tablets is 5.12 grams. Each tablet contains 375 mg of active ingredient. Using these data, determine the following:

1. The amount of active ingredient needed to prepare 60,000 tablets.
A) 307.20 grams
B) 11.718 grams
C) 22.50 kilograms
D) 307.20 kilograms
E)  30.72 kilograms

2. The amount of active ingredient needed to prepare 70 kilograms batch.
A) 136.719 grams
B) 186.70 grams
C) 43.50 grams
D) 51.27 kilograms
E) 5.127 kilograms

3. Determine the percentage amount of additive A per tablet if its actual amount is 35% of total additives.
A) 26.76%
B) 14.81%
C) 9.37%
D) 15.83%
E) 25.63%

4. If the tablet weight specification requires a limit of +/-10%, determine the upper and lower control limits of the tablets.
A) 460.80g - 463.20g
B) 337.50g - 412.50g
C) 460.80mg - 583.20mg
D) 337.50mg - 412.50mg
E) 4.608g - 5.632g

5) At what amount of the active ingredient is the product considered to be expired?
A) below 337.50mg
B) below 375.00 mg
C) below 356.25mg
D) below 365.50mg
E) below 568.89mg

Answers and solution will be given next time!