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?
- Reciprocating Cylinder
- Flow-through cell
- Paddle over disc
- Rotating Cylinder
- Reciprocating disc
5. Question: What is the difference between dissolution and disintegration?
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Answer: Aliquot must be withdrawn from a zone midway between the surface of the dissolution and top of the rotating paddle or basket, not less than 1 cm away from the vessel wall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?
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?
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
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube