Quality control lecture 2

Endotoxin is a lipopolysaccharide from the outer membrane of gram-positive bacteria.

• True

• False

Which of the following methods are currently used for LAL Test? (you may choose more than 1 answer)

• rabbit test

• Gel-clot method

• Chromogenic method

• Microscopic method

As specified in the pharmacopeia, higher bacterial count limit is permitted for non aqueous dosage than the aqueous dosage forms

• True

• false

Answer explanation

The aqueous preparations are more prone to bacterial contamination

In the validation of the selective media, which tests are done

• Indicative properties test

• Inhibitory properties test

• Growth promotion test

• all of the answers

The cetrimide agar plate is selective for

• Pseudomonas spp.

• Lactose

  fermentors

• Lactose

  non fermentors

• E.coli

Tryptone

Soya Agar

(TSA) is used in

• TAMC

• TYMC

• test for anaeorbic bacteria

• selective for staph spp.

while testing for Growth Promoting of selective media

• Incubate at the specified temperature for not more than the shortest time

  specified in the test.

• Incubate at the specified temperature for not less than thelongest time

  specified in the test.

while testing for inhibitory properties of selective media

• Incubate at the specified temperature for not less than the longest time specified in the test.

• Incubate at the specified temperature for not more than the shortest time specified in the test.

Test for candida albicans is usually done for products intended for

• Vaginal use

• Oral use

• cutaneous use

• None of the answers

In the method validation of the total viable count of the limit test, count obtained in the presence of the product should not differ by a factor of two when compared to the count in the absence of the product

• True

• False