3 Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
Related substances (HPLC, Ph. Eur.) (major impurity)
≤ 2.0 %
Related substances (HPLC, EP) (Sum of all impurities)
≤ 3.0 %
Reducing sugars after hydrolysis/total sugar (as glucose)
≤ 0.8
Reducing sugars (as glucose)
≤ 0.11
Sulfated ash
≤ 0.02 %
Loss on drying
≤ 3.0
Water
≤ 1.5 %
Particle size (< 212 µm)
≤ 10 %
Particle size (> 850 µm)
≤ 10 %
Residual solvents (ICH Q3C)
excluded by manufacturing process
Microbiological test
passes test
Colony count (aerobic bacteria (TAMC))
≤ 5*10²
Colony count (Yeasts and moulds (TYMC))
≤ 10²
Salmonella spp.
In 10g substance not detectable
E.coli
In 1g substance not detectable
Staphylococcus aureus
In 1g substance not detectable
Pseudomonas aeruginosa
In 1g substance not detectable
Candida albicans
In 1g substance not detectable
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 an indicated (#). Corresponds to Ph. Eur., BP, JSFA, NF, E 420 Conforms to the purity criteria on food additives according to the current European Commission Regulation.
