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 phosphate
, di-Sodium hydrogen phosphate dodecahydrate
, Dibasic sodium phosphate dodecahydrate
, Disodium phosphate
, Sodium phosphate dibasic dodecahydrate
, Sodium hydrogen phosphate dodecahydrate
, di-Sodium hydrogen orthophosphate dodecahydrate
, Sodium monohydrogen 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 |
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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