Podcast
Questions and Answers
Which test measures the tablet's resistance to abrasion?
Which test measures the tablet's resistance to abrasion?
- Disintegration Test
- Friability Test (correct)
- Dissolution Test
- Hardness Test
Which test evaluates the time it takes for a tablet to break down into smaller particles?
Which test evaluates the time it takes for a tablet to break down into smaller particles?
- Uniformity of Dosage Unit Test
- Thickness and Diameter Test
- Disintegration Test (correct)
- Weight Variation Test
Which test assesses the ability of a tablet to withstand mechanical shocks?
Which test assesses the ability of a tablet to withstand mechanical shocks?
- Dissolution Test
- Friability Test (correct)
- Appearance Test
- Assay Test
Which test measures the force required to break a tablet?
Which test measures the force required to break a tablet?
Which test determines the amount of active ingredient in a tablet?
Which test determines the amount of active ingredient in a tablet?
Which test evaluates the tablet's ability to release the active ingredient over time?
Which test evaluates the tablet's ability to release the active ingredient over time?
Which test is used to determine the weight variation among individual tablets in a sample?
Which test is used to determine the weight variation among individual tablets in a sample?
According to the USP design, how many tablets must contain not less than 85% and not more than 115% of the labeled drug content?
According to the USP design, how many tablets must contain not less than 85% and not more than 115% of the labeled drug content?
In the USP design, if 1 tablet is outside 85-115% of claimed content but within 75-125%, how many additional tablets are assayed?
In the USP design, if 1 tablet is outside 85-115% of claimed content but within 75-125%, how many additional tablets are assayed?
How many tablets must be outside the range of 85-115% for the USP design to require a repeat test on additional 20 tablets?
How many tablets must be outside the range of 85-115% for the USP design to require a repeat test on additional 20 tablets?
What is the maximum allowed RSD for the USP design after the repeat test on additional 20 tablets?
What is the maximum allowed RSD for the USP design after the repeat test on additional 20 tablets?
For coated and uncoated tablets containing less than 50 mg of an active ingredient comprising less than 50% of the weight of one dosage unit, how many tablets must contain labeled amount ± 15% according to the USP design?
For coated and uncoated tablets containing less than 50 mg of an active ingredient comprising less than 50% of the weight of one dosage unit, how many tablets must contain labeled amount ± 15% according to the USP design?
If the RSD is greater than what percentage, the USP design requires another 20 tablets to be assayed?
If the RSD is greater than what percentage, the USP design requires another 20 tablets to be assayed?
What is the acceptable range for labeled drug content as per the USP design?
What is the acceptable range for labeled drug content as per the USP design?
In the USP design, how many tablets may not fall outside of the 85 to 115% range after the remaining 20 tablets are assayed?
In the USP design, how many tablets may not fall outside of the 85 to 115% range after the remaining 20 tablets are assayed?
For tablets containing less than 50 mg of an active ingredient comprising less than 50% of the weight of one dosage unit, what is the maximum allowed RSD as per the USP design?
For tablets containing less than 50 mg of an active ingredient comprising less than 50% of the weight of one dosage unit, what is the maximum allowed RSD as per the USP design?
What is the main purpose of scoring tablets?
What is the main purpose of scoring tablets?
What is the primary factor that determines tablet stability during manufacturing, packaging, and shipping?
What is the primary factor that determines tablet stability during manufacturing, packaging, and shipping?
Which method of granulation generally results in harder tablets?
Which method of granulation generally results in harder tablets?
What could decrease tablet strength despite improving tablet flow?
What could decrease tablet strength despite improving tablet flow?
What is the primary purpose of adding lubricants to tablets?
What is the primary purpose of adding lubricants to tablets?
Which type of tablets has the highest hardness?
Which type of tablets has the highest hardness?
How is the tendency of tablets to crumble or break evaluated?
How is the tendency of tablets to crumble or break evaluated?
What is the purpose of friability testing for tablets?
What is the purpose of friability testing for tablets?
What is the maximum percentage loss allowed in friability testing for tablets?
What is the maximum percentage loss allowed in friability testing for tablets?
Which type of tablets may require special packaging due to their high friability?
Which type of tablets may require special packaging due to their high friability?
What does the shipping test method evaluate for tablets?
What does the shipping test method evaluate for tablets?
What do weight and content uniformity tests indicate for tablets?
What do weight and content uniformity tests indicate for tablets?
What fluid is used for testing weight uniformity in compressed uncoated tablets?
What fluid is used for testing weight uniformity in compressed uncoated tablets?
What is the maximum limit set by USP for content uniformity variation in tablets?
What is the maximum limit set by USP for content uniformity variation in tablets?
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Study Notes
- Friability testing of tablets is conducted using a plastic chamber that revolves at 25 rpm, causing tablets to experience abrasion and shock
- After 4 minutes, the tablets are weighed to determine percentage loss, or friability, which must be less than or equal to 1%
- Friability testing applies to most tablets, but some chewable and effervescent tablets require special packaging due to their high friability
- A shipping test method is used to evaluate a product's ability to withstand transportation and handling
- Official standards, such as the British Pharmacopoeia (B.P.) and US Pharmacopoeia (USP), provide tests and specifications for tablets
- A tablet's uniformity of dosage form is tested through weight and content uniformity, which indicate the consistency of active ingredients and tablet weight for a given batch
- For compressed uncoated tablets, testing fluid is water at 37°C, while coated tablets and some others require longer test times
- Tests for weight and content uniformity involve weighing and comparing individual tablets, and the USP sets a limit of 5% for content uniformity variation
- British Pharmacopoeia test design for weight uniformity requires that none of the 20 tablets deviate from the average weight by more than double the % deviation, and no more than two tablets can deviate by more than the % deviation.
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