Category | Product Description |
1 | Injections, other parenterals including emulsions, otic products, sterile nasal products, and ophthalmic products made with aqueous bases or vehicles. |
2 | Topically used products made with aqueous bases or vehicles, nonsterile nasal products, and emulsions, including those applied to mucous membranes. |
3 | Oral products other than antacids, made with aqueous bases or vehicles. |
4 | Antacids made with an aqueous base. |
Organism | Suitable Medium | Incubation Temperature |
Inoculum Incubation Time |
Microbial Recovery Incubation Time |
Escherichia coli
(ATCC No. 8739) |
SoybeanCasein Digest Broth; SoybeanCasein Digest Agar |
32.5 ± 2.5 | 18 to 24 hours | 3 to 5 days |
Pseudomonas aeruginosa
(ATCC No. 9027) |
SoybeanCasein Digest Broth; SoybeanCasein Digest Agar |
32.5 ± 2.5 | 18 to 24 hours | 3 to 5 days |
Staphylococcus aureus
(ATCC No. 6538) |
SoybeanCasein Digest Broth; SoybeanCasein Digest Agar |
32.5 ± 2.5 | 18 to 24 hours | 3 to 5 days |
Candida albicans
(ATCC No. 10231) |
Sabouraud Dextrose Agar; Sabouraud Dextrose Broth |
22.5 ± 2.5 | 44 to 52 hours | 3 to 5 days |
Aspergillus niger
(ATCC No. 16404) |
Sabouraud Dextrose Agar; Sabouraud Dextrose Broth |
22.5 ± 2.5 | 6 to 10 days | 3 to 7 days |
For Category 1 Products | |
Bacteria: | Not less than 1.0 log reduction from the initial calculated count at 7 days, not less than 3.0 log reduction from the initial count at 14 days, and no increase from the 14 days' count at 28 days. |
Yeast and Molds: | No increase from the initial calculated count at 7, 14, and 28 days. |
For Category 2 Products | |
Bacteria: | Not less than 2.0 log reduction from the initial count at 14 days, and no increase from the 14 days' count at 28 days. |
Yeast and Molds: | No increase from the initial calculated count at 14 and 28 days. |
For Category 3 Products | |
Bacteria: | Not less than 1.0 log reduction from the initial count at 14 days, and no increase from the 14 days' count at 28 days. |
Yeast and Molds: | No increase from the initial calculated count at 14 and 28 days. |
For Category 4 Products | |
Bacteria, Yeast, and Molds: |
No increase from the initial calculated count at 14 and 28 days. |