14 Inorganic salts: Container I. Neutral solutions of the these salts: Container D. Before placing in Container D, check the pH with pH-Universal indicator strips (Item No. 109535).
Safety Information
Product Usage Statements
Storage and Shipping Information
Storage
Store at +5°C to +30°C.
Packaging Information
Transport Information
Supplemental Information
Specifications
Assay (alkalimetric, calculated on dried substance)
98.0 - 100.5 %
Identity
passes test
Appearance of solution
passes test
Insoluble substances
≤ 0.2 %
pH-value (5 %; water)
8.5 - 9.6
Carbonate
passes test
Chloride (Cl)
≤ 0.02 %
Fluoride (F)
≤ 0.001 %
Sulfate (SO₄)
≤ 0.1 %
Al (Aluminium)
≤ 0.0005 %
As (Arsenic)
≤ 0.0002 %
Fe (Iron)
≤ 0.0010 %
Na (Sodium)
≤ 1.5 %
Na (sodium)
passes test
Potassium dihydrogen phosphate
≤ 2.5 %
Potassium dihydrogen phosphate and tri- Potassium phosphate
passes test
Residual solvents (ICH Q3C)
excluded by manufacturing process
Reducing substances
passes test
Loss on drying (130 °C)
≤ 1.0 %
Endotoxins
≤ 2.5 I.U./g
Total aerobic microbial count
≤ 100 CFU/g
Total yeast and mould count
≤ 100 CFU/g
DNases (Exo- and endonucleases) (not detectable)
passes test
RNases (not detectable)
passes test
Proteases (not detectable)
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 (*).
