Disodium hydrogen phosphate dodecahydrate 98.5-102.5% (by acidimetry), crystals, EMPROVE® ESSENTIAL Ph. Eur., BP, JP, USP, SAFC®

Supplier: EMD MILLIPORE – PCS CA EXCEP

Synonyms: sec-Sodium phosphatedi-Sodium hydrogen phosphate dodecahydrateDibasic sodium phosphate dodecahydrateDisodium phosphateSodium phosphate dibasic dodecahydrateSodium hydrogen phosphate dodecahydratedi-Sodium hydrogen orthophosphate dodecahydrateSodium monohydrogen phosphate dodecahydrate

1.06573.9029 1.06573.9026 1.06573.9029 1.06573.9500 1.06573.5000
CA1.06573.9029EA 1513.09 CAD
CA1.06573.9029 EM1.06573.9500 EM1.06573.5000 EM1.06573.9029 EM1.06573.9026
Disodium hydrogen phosphate dodecahydrate 98.5-102.5% (by acidimetry), crystals, EMPROVE® ESSENTIAL Ph. Eur., BP, JP, USP, SAFC®
di-Sodium hydrogen phosphate dodecahydrate

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.

Formula: Na₂HPO₄·12H₂O
MW: 358.14 g/mol
Melting Pt: 35 °C
Density: 1.52 g/cm³ (20 °C)
MDL Number: MFCD00149181
CAS Number: 10039-32-4
Merck Index: 13,08733

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Specification Test Results

Assay (acidimetric) 98.5 - 102.5 %
Assay (acidimetric; calculated on dried substance) 98.5 - 100.5 %
Assay (acidimetric, calculated on dried substance according to JP) 98.0 - 101.0 %
Identity passes test
Appearance of solution passes test
In water insoluble matter ≤ 0.15 %
pH-value (2 %; water) 9.0 - 9.4
pH-value (5 %; water) 9.0 - 9.3
Carbonate passes test
Chloride (Cl) ≤ 0.001 %
Sulfate (SO₄) ≤ 0.01 %
Heavy metals (as Pb) ≤ 0.0008 %
As (Arsenic) ≤ 0.0001 %
Fe (Iron) ≤ 0.001 %
Sodium dihydrogen phosphate (NaH₂PO₄) ≤ 0.8 %
Residual solvents (ICH Q3C) excluded by production process
Substances reducing potassium permanganate (as O) passes test
Loss on drying (130 °C) 57.0 - 61.0 %
Water (according to Karl Fischer) 57.0 - 61.0 %
Corresponds to Ph Eur, BP, USP, JP

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