Exam 1 Quality Control Flashcards
Tablet ______ determines the tablet resistance to chipping, abrasion, or breakage under ________ conditions of storage, transportation, and handling before use
Hardness; ordinary conditions
If the tablet is too ______ it will not stand handling during subsequent processes such as coating, packaging, and shipping
Soft
If the tablet is too _______ it may not disintegrate during an appropriate time interval or meet the dissolution specification
Hard
Hardness tester that measures the force required to break the tablet by using a coiled spring applied diametrically to the tablet
Stokes-Monsato
Stokes Monsato hardness tester has a ______ kg minimum required hardness
4 kg
Hardness tester where force is applied diametrically and produced by a manually operated pump that is calibrated into 30 arbitrary units
Strong-Cobb
Hardness tester that uses the same mechanical principle as ordinary pliers, and applies diametric force
Pfizer
The most widely used hardness tester that is electrically operated and limits operator variability
Scheuniger
Measurement related to hardness by exposing the tablets to rolling and repeat shocks as they freefall within a friabilator
Friability
Loose dust is collected after measuring friability and the tablets are weighed again to determine the weight loss which is known as ________ for friability
Surrogate for friability
True or False: The friability test is applicable to most compressed, coated, and uncoated tablets
False: only compressed, uncoated tablets
For tablets weighing <650mg, the sample should weigh as near as possible to _______
6.5g
For a tablet with a weight of >650mg, how many tablets are used?
10 tablets
True or False: Effervescent and chewable tablets have different friability speculations
True
True or False: Friability tests are generally run once, with a target weight loss value of <1%
True
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
False: Two more sample tests are run, and the average weight loss between the three tests is observed
True or False: If after testing, cracked, cleaved, or broken tablets are present, the sample fails the test
True
______ varies with density of the granulation, compression pressure, or speed of tablet compression, but is not a USP specification
Thickness
Thickness is measured by a ______ that must result in a +/- 5% variance depending on the size of the tablet
Caliper
What determines tablet weight?
The volumetric fill of the die cavity
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
25mg; 25%
How many tablets must be weighed individually to then calculate an overall average?
20 tablets
Percent difference allowed if the average weight is more than 324mg
5%
Percent difference allowed if the average weight is less than 130mg
10%
Percent difference allowed if the average weight is between 130-324mg
7.5%
The ______ _______ test is intended to ensure that the tablets contain the amount of drug claimed on the label, with little variation among tablets
Content uniformity test
The weight variation test and content uniformity test are intended to ensure
Uniformity of dosage units
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
25mg; 25%
True or False: Tablets with a content uniformity requirement are exempt from a weight variation test
True
A measure of the time required for a group of tablets to disintegrate into particles under a given set of conditions
Disintegration test
The disintegration racks moves ____ and _____ in a aqueous medium at ____ degrees C, where the bottom of the basket is covered with a _____-mesh screen
Up and down; 37 degrees C; 10-mesh screen
How many tablets are initially used in the disintegration test?
6
If one or two tablets fails to disintegrate in the first disintegration test, how many tablets are used in the subsequent test?
12
Of the two trials (18 tablets total), how many tablets must disintegrate to be considered a good batch?
16
Uncoated tablets have a disintegration time of
30 minutes
Coated tablets have a disintegration time of
2 hours
Sublingual tablets have a disintegration time of
2 minutes
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
Dissolution test
