Exam 1 Quality Control

Question 1

Tablet ______ determines the tablet resistance to chipping, abrasion, or breakage under ________ conditions of storage, transportation, and handling before use

Answer 1

Hardness; ordinary conditions

Question 2

If the tablet is too ______ it will not stand handling during subsequent processes such as coating, packaging, and shipping

Answer 2

Soft

Question 3

If the tablet is too _______ it may not disintegrate during an appropriate time interval or meet the dissolution specification

Answer 3

Hard

Question 4

Hardness tester that measures the force required to break the tablet by using a coiled spring applied diametrically to the tablet

Answer 4

Stokes-Monsato

Question 5

Stokes Monsato hardness tester has a ______ kg minimum required hardness

Answer 5

4 kg

Question 6

Hardness tester where force is applied diametrically and produced by a manually operated pump that is calibrated into 30 arbitrary units

Answer 6

Strong-Cobb

Question 7

Hardness tester that uses the same mechanical principle as ordinary pliers, and applies diametric force

Answer 7

Pfizer

Question 8

The most widely used hardness tester that is electrically operated and limits operator variability

Answer 8

Scheuniger

Question 9

Measurement related to hardness by exposing the tablets to rolling and repeat shocks as they freefall within a friabilator

Answer 9

Friability

Question 10

Loose dust is collected after measuring friability and the tablets are weighed again to determine the weight loss which is known as ________ for friability

Answer 10

Surrogate for friability

Question 11

True or False: The friability test is applicable to most compressed, coated, and uncoated tablets

Answer 11

False: only compressed, uncoated tablets

Question 12

For tablets weighing <650mg, the sample should weigh as near as possible to _______

Answer 12

6.5g

Question 13

For a tablet with a weight of >650mg, how many tablets are used?

Answer 13

10 tablets

Question 14

True or False: Effervescent and chewable tablets have different friability speculations

Answer 14

True

Question 15

True or False: Friability tests are generally run once, with a target weight loss value of <1%

Answer 15

True

Question 16

True or False: After the first friability test, if the weight loss is more than the target value, the sample fails the test and discarded

Answer 16

False: Two more sample tests are run, and the average weight loss between the three tests is observed

Question 17

True or False: If after testing, cracked, cleaved, or broken tablets are present, the sample fails the test

Answer 17

True

Question 18

______ varies with density of the granulation, compression pressure, or speed of tablet compression, but is not a USP specification

Answer 18

Thickness

Question 19

Thickness is measured by a ______ that must result in a +/- 5% variance depending on the size of the tablet

Answer 19

Caliper

Question 20

What determines tablet weight?

Answer 20

The volumetric fill of the die cavity

Question 21

Weight tolerances of tablets by the USP are applied to both uncoated or film-coated tablets when ___mg or more of drug AND the drug comprises ____% or more, by weight, of the tablet

Answer 21

25mg; 25%

Question 22

How many tablets must be weighed individually to then calculate an overall average?

Answer 22

20 tablets

Question 23

Percent difference allowed if the average weight is more than 324mg

Answer 23

5%

Question 24

Percent difference allowed if the average weight is less than 130mg

Answer 24

10%

Question 25

Percent difference allowed if the average weight is between 130-324mg

Answer 25

7.5%

Question 26

The ______ _______ test is intended to ensure that the tablets contain the amount of drug claimed on the label, with little variation among tablets

Answer 26

Content uniformity test

Question 27

The weight variation test and content uniformity test are intended to ensure

Answer 27

Uniformity of dosage units

Question 28

Content uniformity is applicable to both coated and uncoated tablets containing less than _____mg of drug OR the drug comprises of less than ____% by weight of the tablet

Answer 28

25mg; 25%

Question 29

True or False: Tablets with a content uniformity requirement are exempt from a weight variation test

Answer 29

True

Question 30

A measure of the time required for a group of tablets to disintegrate into particles under a given set of conditions

Answer 30

Disintegration test

Question 31

The disintegration racks moves ____ and _____ in a aqueous medium at ____ degrees C, where the bottom of the basket is covered with a _____-mesh screen

Answer 31

Up and down; 37 degrees C; 10-mesh screen

Question 32

How many tablets are initially used in the disintegration test?

Answer 32

6

Question 33

If one or two tablets fails to disintegrate in the first disintegration test, how many tablets are used in the subsequent test?

Answer 33

12

Question 34

Of the two trials (18 tablets total), how many tablets must disintegrate to be considered a good batch?

Answer 34

16

Question 35

Uncoated tablets have a disintegration time of

Answer 35

30 minutes

Question 36

Coated tablets have a disintegration time of

Answer 36

2 hours

Question 37

Sublingual tablets have a disintegration time of

Answer 37

2 minutes

Question 38

Test that measures the amount of time required for a certain percentage of API in the tablet to dissolve under a specified set of conditions, intending to provide a step toward evaluation of the bioavailability of the drug

Answer 38

Dissolution test