Disodium hydrogen phosphate dihydrate, EMPROVE® EXPERT Ph. Eur., BP, USP, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS

1.37036.5000 1.37036.9012 1.37036.9029
1.37036.5000EA 480 EUR
1.37036.5000 1.37036.9012 1.37036.9029
Disodium hydrogen phosphate dihydrate, EMPROVE® EXPERT Ph. Eur., BP, USP, SAFC®
di-Sodium hydrogen phosphate dihydrate

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 (*).


Certifications: Corresponds to Ph Eur, BP, USP

Formula: Na₂HPO₄·2H₂O
Melting Pt: 92,5 °C
Density: 2,1 g/cm³ (20 °C)
Storage Temperature: Ambient
MDL Number: MFCD00149182
CAS Number: 10028-24-7
EINECS: 231-448-7

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Specification Test Results

Assay (calculated on dried substance according to Ph Eur) 98.0 - 101.0 %
Assay (calculated on dried substance according to USP) 98.0 - 100.5 %
Identity passes test
Appearance of solution passes test
In water insoluble matter ≤ 0.3 %
pH-value (5 %; water) 8.9 - 9.2
Chloride (Cl) ≤ 0.005 %
Sulfate (SO₄) ≤ 0.02 %
Heavy metals (as Pb) ≤ 0.001 %
As (Arsenic) ≤ 0.0002 %
Fe (Iron) ≤ 0.001 %
Sodium dihydrogen phosphate (NaH₂PO₄) ≤ 1.7 %
Residual solvents (ICH Q3C) excluded by manufacturing process
Substances reducing potassium permanganate (as O) passes test
Loss on drying (130 °C) 19.5 - 21.0 %
Endotoxins ≤ 2.5 I.U./g
Total aerobic microbial count ≤ 1E+02 CFU/g
Total yeast and mould count ≤ 1E+02 CFU/g
DNases (Exo- and endonucleases) (not detectable) passes test
RNases (not detectable) passes test
Proteases (not detectable) passes test

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