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. 2014 Feb 14;15(3):542–549. doi: 10.1208/s12249-014-0094-y

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