18 Disintegration test interview Questions and answers for Pharma QC

In this article we will understand the disintegration test interview questions and answers. Quality control having multiple instruments and equipments, today we will understand disintegration instrument and it’s purpose.

Interview is an opportunity if you take it positive or in simple word the person who wants to grow in his carrier is always ready for challenges and the others always ready with justification.

Interview is a part of selection procedure of a candidate in any organization, it may be private or government organization.

What is interview?

Interview is a procedure to judge a knowledge and behavior of candidate within short period of time.

Here basically we will understand the quality control interview questions and answers on disintegration test for quality control in pharmaceutical industry. Disintegration test is known as “DT”.

Disintegration test interview questions and answers:

In pharmaceutical there are multiple instruments are used. Some are used to generate the quantitative results and some instruments are used to understand qualitative results. Qualitative results are helps to predict the product quality.

Disintegration test is comes under second category that is qualitative test, to understand the behavior ofvtge drug product or can called it as a physical test.

Basically disintegration test is perform to understand the disintegration time of the tablet or capsules. How much time tablet or capsules are taking to disintegrate into fragments that can be measure by DT.

Lets understand with disintegration test interview questions and answers in details.

Q1. What is USP general chapter number for disintegration test?

Ans: USP general chapter number <701>

Q2. What is disintegration time (DT)?

Ans: Disintegration time is a time required for tablets/capsules to break into small fragments.

Q3. Why disintegration test need to perform?

Ans: To measure the tablets/capsules are disintegrating within the time or not.

Q4. What shall be the temperature of the medium?

Ans: 37℃ +/- 2℃ shall be the temperature of the disintegration test medium.

Q5. How many tablets/capsules are used for disintegration test analysis?

Ans: For L1 stage 6 and for L2 12 tablets/capsules are used for disintegration test analysis.

Q6. What is L1 and L2 stage in disintegration test?

Ans: Disintegration shall be perform in two stages i.e. L1 and L2. If L1 fails then L2 need to perform.

Q7. What is acceptance criteria for disintegration test?

Ans: For L1 stage all (6) units shall be disintegrate and in L2 stage (12) units analyzed and out of 18 units (L1 + L2) 16 units shall be disintegrate.

Disintegration test
Disintegration test

Q8. Why disc is used in Disintegration test?

Ans: To avoid the floating of capsules, disc is used in DT.

Q9. What is cycle frequency in DT?

Ans: 29 to 32 cycles per minute through a distance of 55 +/- 2mm.

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Q10. What is upward stroke position in disintegration test?

Ans: Upward stroke in such a way that the wire mesh shall be below 15 mm from the medium of the surface.

Q11. What is downward stroke position in disintegration test?

Ans: The downward stroke position in such away that the wire mesh shall be above 25mm from the bottom of the vessel.

Q12. What is disintegration time of tablets?

Ans: Uncoated tablet 15 minutes

Soluble tablet 3 mins.

Dispersible tablet 3 mins.

Effervescent tablet 5 mins.

Enteric coated tablet, should not disintegrate in 120 mins in HCl but should disintegrate in buffer within 2 hrs.

sugar coated, 60 mins

Film coated, 30 mins.

Q13. What is disintegration time for capsules?

Ans: Hard capsules 30 mins

Soft capsules 30 mins

Enteric capsules, should not disintegrate in 120 mins in HCl and disintegrate in buffer within 2 hrs.

Q14. Which tablet takes to Longer time to disintegrate?

Ans: Enteric coated tablets takes longer time to disintegrate.

Q15. Which tablet disintegrate in less time?

Ans: Soluble tablets takes very less time to disintegrate. (3 mins).

Q16. What are the factors affecting disintegration time of tablet?

Ans: Lubricant, binder and hardness of the tablet are the factors affecting on disintegration time of tablet.

Q17. What if L1 stage fails?

Ans: If L1 stage fails then L2 stage shall be perform and 12 units shall be used for analysis.

Q18. What is difference between Disintegration test and dissolution test?

Ans: Disintegration test : It is time required fir the tablets or capsules to disintegrate into fragments in given set of condition.

Dissolution test: It is a time required for the tablets or capsules to dissolve into a dissolution medium in a given set of condition.

Here I tried to cover maximum disintegration test interview questions and answers for quality control in pharmaceutical. But still you have any questions you can suggest.

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