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Answer: Aliquot must be withdrawn from a zone midway between the surface of the dissolution and top of the rotating paddle or basket, not less than 1 cm away from the vessel wall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