33 Questions
A microbiological test is suitable for revealing the presence of viable forms of bacteria, fungi, and yeasts in pharmaceutical articles.
STERILITY TEST
This requires the most critical evaluation for sterility.
IV INJECTION
Culture Media for for Streptococcus species
Soybean Casein Digest Medium
Culture Media for Clostridium species
Fluid Thioglycollate Medium
What is the main purpose of sterility testing in pharmaceuticals?
To detect the presence of viable microorganisms
Which of the following microorganisms is used as a biological indicator for sterilization by moist heat?
Bacillus stearothermophilus
What is the primary purpose of the pyrogen test?
To detect the presence of fever-causing substances
What is the name of the medium used for sterility testing of anaerobes?
Fluid Thioglycollate Medium
What is the consequence of violating aseptic/sterile technique during sterility testing?
A retest is required
What is the incubation period for fungi in sterility testing?
5-7 days
What is the amount of granules that are classified as poor based on the Hausner's ratio?
45.78 grams
What is the percentage of granules that pass through all sieves/mesh sizes?
19.43%
What is the formula to calculate the true volume of the granules?
V = (M/D)
What is the normal range of moisture content for granules?
0.55 to 2.0%
What is the consequence of having a low moisture content in granules?
It is prone to capping, chipping, and lamination
What is the name of the device used to measure the moisture content of granules?
Ohaus Moisture Balance
What is the primary reason for the occurrence of creaming in emulsions?
Temporary separation of particles
What is the ideal particle size for suspensions?
Greater than 1 um
What is the purpose of the Cobalt Chloride test?
To determine the type of emulsion
What is the result of phase inversion in an emulsion?
Reversal of the emulsion type
What is the purpose of the Centrifugation-Temperature Stress test?
To test for crystal growth
What is the term for the agglomerates of powders, such as granules?
Agglomerates
What is the minimum percentage of net content required for a product weighing between 60 g or mL and 150 g or mL?
95%
What is the purpose of the DYE SOLUBILITY TEST in emulsions?
To determine the type of emulsion (O/W or W/O)
What is the advantage of a flocculated suspension?
It can be easily redispersed once shaken
What is the significance of a high zeta potential in a suspension?
It indicates a slower rate of settling
What is the purpose of the UV FLUORESCENCE test in emulsions?
To determine the type of emulsion (O/W or W/O)
What is the significance of a settled height of 18cm in the sedimentation volume test?
It indicates a sedimentation volume of less than 1.0
What is the primary requirement for a test organism in microbial assay for vitamins?
Inability to synthesize the vitamins being assayed
What is the interpretation of a zone of inhibition of less than 10 mm in the plate method?
The organism is resistant to the test drug
Which of the following microorganisms is used to assay vitamin B12?
Lactobacillus leichmanii
What is the purpose of the turbidimetric assay?
To measure the growth of microorganisms in a suspension
What is the incubation period for fungi in the plate method?
5-7 days
This quiz assesses your knowledge of microbiological tests used to detect viable forms of bacteria, fungi, and yeasts in pharmaceutical products. Test your understanding of these important quality control measures.
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