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WorksheetsQC of Herbal Products
Total questions: 15
Worksheet time: 11mins
Which one refers to a quality control test that measures the amount of moisture (or volatile matter) present in a finished product?
Dissolution
Disintegration
Friability
Loss on drying
Hardness
A batch of herbal capsules has an average content weight of 400 mg. What is the absolute maximum weight limit (in mg) that no single capsule in the batch may exceed for the test to pass?
460 mg
440 mg
430 mg
420 mg
Which one helps to determine the mechanical strength and durability of tablets, ensuring they can withstand handling, packaging, shipping, and normal use without breaking apart?
Dissolution
Disintegration
Friability
Loss on drying
Hardness
Which one helps to determines whether a tablet or capsule breaks down into smaller particles within a prescribed time?
Dissolution
Disintegration
Friability
Loss on drying
Hardness
Which of the following is the maximum allowable time for a standard Uncoated Herbal Tablet to disintegrate when tested in the specified immersion fluid in the THP?
not exceed 15 minutes
not exceed 30 minutes
not exceed 45 minutes
not exceed 1 hour
In the Disintegration Test, if an uncoated herbal tablet fails the initial test (meaning 3 out of 6 tablets did not disintegrate), what is the required next step?
The test must be repeated on 12 additional tablets from the same batch.
The test must be repeated on 6 more tablets using a different immersion fluid.
The batch fails the test and cannot be released.
The entire batch must be immediately rejected.
Which one helps to measures the rate and extent to which the active ingredient dissolves from a solid dosage form (like a tablet or capsule) into a liquid medium?
Dissolution
Disintegration
Friability
Loss on drying
Hardness
Total Aerobic Microbial Count (TAMC) measures the number of viable yeasts and molds present in the sample.
True
False
The Thai Herbal Pharmacopoeia (THP) acceptance criterion for Pseudomonas aeruginosa in Luk Pra Kob is not more than 5x107 CFU/g.
True
False
What is the maximum acceptable limit for the Total Combined Yeasts and Moulds Count (TYMC) in a Topical Herbal Cream intended for application to intact skin, according to THP?
not more than 2x 101 CFU/g or mL
not more than 102 CFU/g or mL
not more than 5x102 CFU/g or mL
not more than 5x104 CFU/g or mL
The Thai Herbal Pharmacopoeia (THP) requires the absence of Clostridium species in a specified sample amount.
True
False
The microbial limit test for Pseudomonas aeruginosa is particularly stringent for Nasal Inhalers and Topical Creams. Why is the absence of this specific microorganism mandatory for these dosage forms?
It is an indicator of yeast and mould contamination.
It produces highly visible pigmentation that affects product aesthetics.
It breaks down herbal active ingredients at room temperature.
It is a highly opportunistic pathogen resistant to many preservatives and can thrive in aqueous environments.
Which of the following organisms is a specified pathogen that must be absent from Luk Pra Kob (Herbal Compress Balls) due to the high risk of infection when applied to warm, intact, or broken skin?
Bile-tolerant Gram-negative Bacteria
Staphylococcus aureus
Total Aerobic Microbial Count (TAMC)
Candida albicans
The Limits Test for Lead (Pb) in the Thai Herbal Pharmacopoeia (THP) is not more than..........
0.3 ppm
1.0 ppm
10 ppm
0.1
The Limits Test for Cadmium (Cd) in the Thai Herbal Pharmacopoeia (THP) is not more than..........
0.3 ppm
1.0 ppm
10 ppm
0.1
