Study Set Content:
If no evidence of microbial growth is found
complies with test for sterility
If evidence of microbial growth is found
does not complies with test for sterility
Refers to the extraneous, mobile, undissolved particles, other than gas bubbles, unintentionally present in the solutions.
Particulate Matter Test
Method A –
– Light Obscuration Particle Count Test
Method B –
Microscopic Particle Count Test
Use a suitable apparatus based on principle of light blockage which allows an automatic determination of the size of particles and the number of particles according to size
Light Obscuration Particle Count Test
LVP >= 100 ml particle size in um
10 25
LVP >= 100 ml Maximum no. of particles 10 um
25 per ml
LVP >= 100 ml Maximum no. of particles 25 um
3 per ml
100 ml and less than 100 ml
SVP
SVP 10 um
6000 per container
SVP 25um
600 per container
LVP >= 100 ml Maximum no. of particles 10 um
12 per ml
LVP >= 100 ml Maximum no. of particles 25 um
2 per ml
SVP 10 um
3000 per container
SVP 25 um
300 per container
Test for Ocular Toxicity and Irritation • Test animals:
5 albino rabbits
Requirement:
No change in the eye into which the preparation is instilled
Product are tested using cultures of microorganisms like Aspergillus niger, Candida albicans, Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa.
Test for Preservative Efficacy
The most common human skin yeast
Candida albicans
