Test your knowledge of pharmaceutical QC microbiology: USP <61> microbial enumeration, <62> specified microorganisms, <71> sterility, growth promotion testing, serial dilution and acceptance criteria. There are 15 questions. Click an answer to see whether you are right, with a short explanation.
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1.Under USP <61>, the TAMC is determined on Soybean-Casein Digest Agar incubated at:
Answer: C. TAMC plates (SCDA/TSA) are incubated at 30–35 °C for 3–5 days. TYMC plates (SDA) are incubated at 20–25 °C for 5–7 days. TAMC/TYMC guide →
2.Which medium is used for the TYMC?
Answer: B. The total combined yeasts and moulds count is performed on Sabouraud Dextrose Agar at 20–25 °C for 5–7 days. TAMC/TYMC guide →
3.For the growth-promoting test, each organism's inoculum should be:
Answer: A. A low inoculum of not more than 100 CFU challenges the medium realistically. For inhibitory properties, at least 100 CFU is used. Growth promotion test guide →
4.A solid medium passes the growth promotion test when recovery is:
Answer: C. USP <61> requires growth on solid media not to differ by more than a factor of 2 from the standardized inoculum or the approved reference batch. Growth promotion test guide →
5.When counting TYMC plates under USP <61>, use the plates with the highest number of colonies below:
Answer: C. Count TYMC plates below 50 colonies and TAMC plates below 250 colonies. TAMC/TYMC guide →
6.For a non-aqueous oral preparation, the TAMC criterion of 10^3 CFU/g means a maximum acceptable count of:
Answer: C. Under USP <1111>, 10^1 means a maximum of 20, 10^2 a maximum of 200, and 10^3 a maximum of 2,000. TAMC/TYMC guide →
7.ATCC 14028, used in the USP <62> test for Salmonella, is:
Answer: B. ATCC 14028 is Salmonella enterica subsp. enterica serovar Typhimurium (serovar Abony NCTC 6017 is an alternative). It is not S. Typhi. Growth promotion test guide →
8.Which medium is used in the sterility test (USP <71>) mainly for anaerobic and aerobic bacteria?
Answer: D. Fluid Thioglycollate Medium (30–35 °C) supports anaerobes and aerobes. Soybean-Casein Digest Medium (20–25 °C) is used mainly for fungi and aerobic bacteria. Growth promotion test guide →
9.The sterility test media are incubated for not less than:
Answer: B. USP <71> requires incubation of the test media for not less than 14 days.
10.Which organism is used for the growth promotion test of Sabouraud Dextrose Agar for the TYMC?
Answer: D. SDA for TYMC is tested with Candida albicans ATCC 10231 and Aspergillus brasiliensis ATCC 16404. Growth promotion test guide →
11.Transferring 1 mL of sample into 9 mL of diluent gives a dilution of:
Answer: D. Dilution = sample ÷ (sample + diluent) = 1 ÷ 10, a tenfold (10^-1) dilution. Serial dilution guide →
12.1 mL of a 1:10 dilution is pour-plated in duplicate, giving 23 and 27 colonies. The TAMC is:
Answer: C. Mean = 25 colonies from 0.1 g of product, so 25 × 10 = 250 CFU/g. TAMC/TYMC guide →
13.In USP <62>, which selective agar is used for Pseudomonas aeruginosa?
Answer: C. Cetrimide Agar is selective for P. aeruginosa. Mannitol Salt Agar is used for S. aureus, XLD for Salmonella and MacConkey for E. coli. Growth promotion test guide →
14.In the USP <62> test for E. coli, MacConkey Broth is incubated at:
Answer: D. MacConkey Broth is incubated at 42–44 °C for 24–48 hours before subculture on MacConkey Agar at 30–35 °C. Growth promotion test guide →
15.Test cultures used for growth promotion should be not more than how many passages from the reference culture?
Answer: C. A seed-lot technique keeps working cultures within 5 passages of the original master seed lot. Growth promotion test guide →