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.
Safety Information
Product Usage Statements
Storage and Shipping Information
Storage
Store at +15°C to +25°C.
Packaging Information
Transport Information
Supplemental Information
Specifications
Assay (calc. on anhydrous substance)
97.5 - 102.0 %
Identity (IR)
passes test
Identity (spec. rotation calc. on anhydrous substance)
passes test
Identity (HPLC)
passes test
Identity (water)
passes test
Appearance of solution
passes test
Color and clarity of solution
passes test
Titrable acid
≤ 0.002 meq/g
Conductivity
≤ 20 µS/cm
Spec. rotation (α25/D)
52.5 - 53.0 °
In water insoluble matter
≤ 0.005 %
Chloride (Cl)
≤ 0.01 %
Sulfate and sulphite (as SO₄)
≤ 0.005 %
Heavy metals (as Pb)
≤ 5 ppm
Fe (Iron)
≤ 5 ppm
Related substances [sum of impurities A (maltose) and B (isomaltose)!
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
Endotoxins
≤ 10 I.U./g
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 (*).
