Microbiological purity (Total yeast and mould count (TYMC))
≤ 100 CFU/g
Bile tolerant Gram negative Bacteria (absent in 1 g)
passes test
Escherichia coli (absent in 1 g)
passes test
Pseudomonas aeruginosa (absent in 1 g)
passes test
Staphylococcus aureus (absent in 1 g)
passes test
Candida albicans (absent in 1 g)
passes test
Salmonella ssp (absent in 10 g)
passes test
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).