Que 1: Which capsule is bigger in size – size ‘0’ or size ‘1’?
Ans: ‘0’ size
Que 2: Water for pharmaceutical use shall be free heavy metals why ?
Ans: Heavy metals like lead and arsenic are highly cumulative neurotoxic metals, heavy metals are not eliminated out of our body easily like other drugs and molecules but heavy metals bind with proteins and tend to get accumulated in fatty tissues, nerve tissue is most likely to get damaged by heavy metals, heavy metal causes nervous tissue damage there for water must be free from heavy metals.
Que 3: Change in the size or shape of the original container requires any stability study?
Ans: Change in the size or shape of the original container may not necessitate the initiation of new stability study.
Que 4:What is the formula for calculating number of air changes in an area?
Ans: Number of air changes/hour in an area is
= Total Room Airflow In CFM x 60/Total Volume of room in cubic feet
For calculating Total Room Airflow in CFM, first calculate air flow of individual filter. Formula is given below.
Air flow (in cfm) = Avg.air velocity in feet/Minute x Effective area of filter
Then find Total air flow.
Formula is as follow-
Total Air flow = Sum of air flow of individual filter.
Air flow Velocity can be measured with the help of Anemometer.
Que 5: How many Tablets shall be taken for checking friability?
Ans: For tablets with unit mass equal or less than 650 mg, take sample of whole tablets corresponding to 6.5g.For tablets with unit mass more than 650mg,take a sample of 10 whole tablets.
Que 6: What is the formula for calculating weight loss during friability test?
Ans: %Weight loss = Initial Weight – Final Weight X 100/Initial Weight
Que 7: What is the pass or fail criteria for friability test?
Ans: Generally the test is run for once. If any cracked, cleaved or broken tablets present in the tablet sample after tumbling, the tablets fails the test. If the results are doubtful, or weight loss is greater than the targeted value, the test should be repeated twice and the mean of the three tests determined. A mean weight loss from the three samples of not more than 1.0% is considered acceptable for most of the products.
Que 8: What is the standard number of rotations used for friability test?
Ans: 100 rotations
Que 9: Why do we check hardness during in process checks?
Ans: To determine need for the pressure adjustments on the tableting machine. Hardness can affect the disintegration time. If tablet is too hard, it may not disintegrate in the required period of time. Further if tablet is too soft it will not withstand handling and subsequent processing such as coating, packing etc.
Que 10: What are the factors which influence tablet hardness?
Ans:
- compression force
2. Binder quantity(More binder more hardness)
3. Moisture content
