Microbial and Heavy Metal Contaminant of Antidiabetic Herbal Preparations Formulated in Bangladesh

Table 3

Microbial limits for finished herbal/botanical preparations (in colony-forming units/gram (cfu/g) or colony-forming units/mL (cfu/mL)) (current as of July 2014).

Reference	EP category C	USP	WHO
Product	Product with Ingredients demonstrated to fail Catergory B w/Processing/Pretreatment	Containing botanical ingredients	Herbal materials for internal use
Total aerobic microbial count	10^5 (maximum acceptance limit: 5 × 10^5)	10^4	10^5
Total combined yeast and mold count	10^4 (maximum acceptance limit: 5 × 10^4)	10^3	10^3
Enterobacterial count (bile-tolerant Gram negative bacteria)	10^4	NA	10^3 (other than E. coli)
Escherichia coli	Absence in 1 g	Absence in 10 g	10 in 1 g
Salmonella spp.	Absence in 25 g	Absence in 10 g	Absence in 1 g
Staphylococcus aureus	NA	NA	NA
Clostridia	NA	NA	Absence in 1 g
Shigella	NA	NA	Absence in 1 g

EP: European Pharmacopoeia Edition 8.0, 5.1.8 (microbiological quality of herbal medicinal products for oral use and extracts used in their preparation), 2013.
USP: United States Pharmacopeial Convention, USP-NF 37-32, 2014.
WHO: World Health Organization, WHO Guidelines for Assessing Quality of Herbal Medicines with Reference to Contaminants and Residues, 2007.
NA: not assigned.