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.
Storage Store at +2° C to +30° C.
Declaration (railroad and road) ADR, RID Kein Gefahrgut
Declaration (transport by air) IATA-DGR No Dangerous Good
Declaration (transport by sea) IMDG-Code No Dangerous Good
Appearance of solution (100g/l, CO-free water) clear and colorless
Acidity or alkalinity passes test
pH (50g/l CO-free water) 7.5 - 8.5
In water insoluble matter # ≤ 50 ppm
Chloride (Cl) ≤ 30 ppm
Sulfate (SO) ≤ 50 ppm
Heavy metals (as Pb) ≤ 5 ppm
Al (Aluminium) ≤ 5 ppm
As (Arsenic) ≤ 2 ppm
NH 4 (Ammonium) # ≤ 30 ppm
Ca (Calcium) # ≤ 50 ppm
Fe (Iron) # ≤ 5 ppm
Oxalate (as CHO) ≤ 300 ppm
Tartrate (CHO) passes test
Residual solvents (ICH (Q3C)) excluded by manufacturing process
Readily carbonisable substance passes test
Water (according to Karl Fischer) 11.0 - 13.0 %
Loss on drying (180° C, 18h) 10.0 - 13.0 %
Total aerobic microbial count (TAMC) ≤ 100 CFU/g
Total combined yeasts/moulds count (TYMC) ≤ 10 CFU/g
Bile-tolerant gram-negative bacteria (absent in 1 g) passes test
Candida albicans (absent in 1 g) passes test
Escherichia coli (absent in 1 g) passes test
Pseudomonas aeruginosa (absent in 1 g) passes test
Salmonella (absent in 10 g) passes test
Staphylococcus aureus (absent in 1 g) passes test
Bacterial endotoxins ≤ 2.5 I.U./g
# Additional requirements by ACS
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 (*).
