. Author manuscript; available in PMC: 2016 Jan 31.

Published in final edited form as: Drug Saf. 2015 Feb;38(2):117–128. doi: 10.1007/s40264-014-0250-z

Table 4. Maximum limits of microbials and aflatoxins.

Item	US Pharmacopoeia 32	European Pharmacopoeia 7.0
Microbial limits
Total aerobic microbial	10⁵ CFU/g	10⁴ CFU/g
Total combined yeasts/molds	10³ CFU/g	10² CFU/g
Enterobacterial count (bile-tolerant Gram-negative bacteria)	10³ CFU/g	10² CFU/g
Escherichia coli	Absence in 10 g	Absence
Salmonella	Absence in 10 g	Absence
Aflatoxins
Aflatoxin B1	≤2 ppb	≤2 ppb
Aflatoxin B2	≤0.54 ppb
Aflatoxin G1	≤1.7 ppb
Aflatoxin G2	≤0.4 ppb
Sum of Aflatoxin B1, B2, G1, G2		≤4 ppb

CFU colony-forming units, ppb parts per billion