Table 2 Acceptance criteria for microorganism’s enumeration tests of non-sterile pharmaceutical products according to USP
From: Microbiological quality of non-sterile pharmaceuticals in Egypt
Route of administration | TAMC (CFU/ml or g) | TYMC (CFU/ml or g) | Specified microorganisms |
|---|---|---|---|
Non-aqueous oral preparations | 103 | 102 | Absence of E. coli (1 g or 1 ml) |
Aqueous oral | 102 | 101 | |
Topical preparations | 102 | 101 | Absence of S. aureus and P. aeruginosa (1 g or 1 ml) |
Recommended USP microbial limits for botanical ingredients | |||
 Herbal products | 104 | 103 |  |