di-Sodium hydrogen phosphate dihydrate, extra pure, Pharmpur®, Ph Eur, BP, USP
- assay (acidimetric, referred to
dried sample): 98,0 – 100,5 %
identification: passes test
appearance of solution: clear and colorless
insoluble in water: Max. 0,4 %
arsenic (As): max. 4 ppm
chlorides (Cl): max. 400 ppm
sulfates (SO4): max. 0,1 % - iron (Fe): max. 40 ppm
monosodium phosphate: max. 2,5 %
reducing substances: passes test
loss on drying (130 ºC): 19,5 – 21,0 %
Elemental impurities are analyzed according to the guideline
CHMP/ICH/353369/2013.
Residual solvents are analyzed according to the guideline
CPMP/ICH/283/95
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