AAPS

September 2017 Contents

2017-09-01

How Much Do You Know about Dissolution Testing?


17 Sept_eLearning
 

1. What are sink conditions?
a. How long it takes for the tablet to sink to the bottom of the vessel
b. Volume three times that of a saturated solution
c. Static conditions in a vessel with paddle running
d. Conditions needed to saturate a solution

2. Which agency first adopted good manufacturing practices requirements?
a. European Medicines Agency
b. World Health Organization
c. Food and Drug Administration (FDA)
d. U.S. Pharmacopeial Convention (USP)

3. What are the options for calibration that are acceptable to FDA?
a. Performance verification test
b. Enhanced mechanical calibration
c. Either
d. Both

4. Data evaluation—system suitability of analysis method must be met.
a. True
b. False

5. Automation combined with online UV measurement and _____ can provide a dramatic increase in productivity over manual testing?
a. An auto-sampler
b. A filter changer
c. An electronic notebook system
d. A power converter

6. The screens that retain the dosage form in the cylinder are:

a. not specified in terms of mesh size in the USP <711> Dissolution Chapter
b. optional for the top cap but mandatory for the bottom cap
c. specified in terms of mesh size in the USP Monographs utilizing Apparatus 3
d. all of the above

7. What is the earliest type of dissolution apparatus discussed by FDA most similar to?
a. Apparatus 1
b. Apparatus 2
c. Apparatus 3
d. Apparatus 4

Need to brush up on your knowledge? Check out AAPS’ ecourse, Dissolution for Solid Oral Dosages!

ANSWERS: B, C, C, A, C, D, D