Dissolution (Question & Answer)

Dissolution (Question & Answer)

1. Question: What is dissolution?

Answer:  Dissolution is the time require to release the active drugs substances into liquid form in a dissolution medium under setup conditions (RPM, Time, and Temperature).

2. Question: What is USP chapter No. for Dissolution?

Answer: USP chapter No, <711>

3. Question: How many Types of dissolution?

Answer: total 07 types of dissolution in USP

4. Question: What are the names of the 7 types of dissolution?

Answer:

  • Basket
  • Paddle
  • Reciprocating Cylinder
  • Flow-through cell
  • Paddle over disc
  • Rotating Cylinder
  • Reciprocating disc

5. Question: What is the difference between dissolution and disintegration?

Answer:

Dissolution: It is Time required to drugs dissolve in a Medium.

Disintegration: It is the time required to break drug into fragments

6. Question: As per USP –What are Type 1/Apparatus and Type 2/ Apparatus 2 dissolution?

Answer: As per USP, Type 1/Apparatus is Basket and Type 2/ Apparatus 2 is Paddle

7. Question: As per IP –What are Type 1/Apparatus and Type 2/ Apparatus 2 dissolution?

Answer: As per USP, Type 1/Apparatus is Paddle and Type 2/ Apparatus 2 is Basket

8. Question: What is Q value in dissolution?

Answer: Q value is the amount of dissolved active ingredients that is not label claim

9. Question: What is the Temperature of dissolution Media?

Answer: 37 0C ± 0.5 0C

10. Question: Does the Dissolution test applicable for liquid samples?

Answer: Yes, It is applicable to liquid samples also

11. Question: What is the aliquot withdrawal position of the dissolution Sample?

Answer: Aliquot must be withdrawn from a zone midway between the surface of the dissolution and top of the rotating paddle or basket, not less than 1 cm away from the vessel wall

12. Question: What does mean by dissolution profile?

Answer: Dissolution profile is an in-vitro study to identify % rate of drug dissolved at different time intervals.

13. Question: How Many stages are in the dissolution Test?

Answer: Three-stage of Dissolution test Analysis i.e. S1, S2, S3.

14. Question: Does Dissolution is the same for all types of formulation?

Answer:  No, It is different for different formulations.

15. Question: How many Units are analyzed in each stage?

Answer:  

S1 – 6 Units

S2 – 6 Units (Total 12 units S1+S2)

S3 – 12 Units (Total 24 units S1+S2+S3)

16. Question: What are the acceptance criteria for dissolution as per USP or What are S1, S2, and S3 Criteria as per USP?

Answer:  

S1 = Each Unit should be Q+5%.

S2 =Each unit should be equal to or more than the Q value and no unit is less than Q+15%.

S3 =Each unit should be more than Q, Not more than 2 units are less than Q-15% and No unit is less than Q-25%.

17. Question: Does dissolution is an in-vitro study or an in-vivo study?

Answer:   Dissolution is the in-vitro study  (Means outside the body)

18. Question: Why does dissolution need to perform?

Answer:   To identify the % drug dissolved in the respective medium

19. Question: Which make of dissolution Instrument do you handle?

Answer: Electrolab 2. Labindia

 

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