Table 1.
Microorganisms and postinoculation time points tested in this protocol and required by EP-A and USP/JP [11-13]
Microorganisms included in all tests | |||
---|---|---|---|
Pseudomonas aeruginosa | |||
Staphylococcus aureus | |||
Candida albicans | |||
Aspergillus brasiliensis | |||
Escherichia coli* | |||
Time points | Protocol | EP-A | USP/JP |
0 hour | T | T | T |
6 hours | T | T | N |
24 hours | T | T | N |
7 days | T | T (mold only) | T |
14 days | T | N | T |
28 days | T | T | T |
JP: Japanese Pharmacopoeia; N: not included in test; T: included in test; USP: United States Pharmacopeia.
*By European Pharmacopoeia-A (EP-A) standards, only required for oral products [11].