Table II.
Microbiological specification for capsules according to the European Pharmacopoeia
| Test | Specification |
|---|---|
| Total aerobic microbial count | Maximum 1,000/g |
| Total yeasts/molds count | Maximum 100/g |
| Escherichia coli | Absence in 1 g |
| Salmonella species | Absence in 10 g |
| Staphylococcus aureus | Absence in 1 g |
| Pseudomonas aeruginosa | Absence in 1 g |