Page 20 - Quality control of pharmaceuticals (07-PA 704) practical

4. Growth of red colonies indicates the possible presence of Salmonella. This is confirmed
by confirmatory tests according to SOP No. CP/ML/GR/01.

5. The material complies with the test if no red colonies are present or if the confirmatory
tests are negative.

B.3) Test for Pseudomonas aeruginosa

1. Prepare a sample using a 1:10 dilution of not less than 1 g of the material to be
examined.

2. Use 10 ml or the volume corresponding to 1 g of the material to inoculate a suitable
amount of soybean casein digest broth and mix. Incubate at 30-35C for 18-24 hours.

3. Subculture on a plate of cetrimide agar. Incubate at 30-35C for 18-72 hours.
4. Growth of colonies indicates the possible presence of Pseudomonas aeruginosa. This

is confirmed by confirmatory tests according to SOP No. CP/ML/GR/01.
5. The material complies with the test if there is no growth of colonies or if the

confirmatory tests are negative.

B.4) Test for Staphylococcus aureus
1. Prepare a sample using a 1:10 dilution of not less than 1 g of the material to be
examined.
2. Use 10 ml or the volume corresponding to 1 g of the material to inoculate a suitable
amount of soybean casein digest broth and mix. Incubate at 30-35C for 18-24 hours.
3. Subculture on a plate of mannitol salt agar. Incubate at 30-35C for 18-72 hours.
4. Growth of yellow or white colonies surrounded by a yellow zone indicates the possible
presence of Staphylococcus aureus. This is confirmed by confirmatory tests according
to SOP No. CP/ML/GR/01.
5. The material complies with the test if there is no growth of the types of colonies
described or if the confirmatory tests are negative.

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