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di-Sodium hydrogénophosphate heptahydraté, EMPROVE® ESSENTIAL USP, DAC suitable for use as excipient, SAFC®

Fournisseur: MERCK PRODUCTION CHEMICALS

Synonyms: Sodium phosphate dibasic heptahydrate, Sodium hydrogen phosphate heptahydrate, Sodium monohydrogen phosphate heptahydrate

1.06574.1000 1.06574.9029
1.06574.1000EA 140 EUR
1.06574.1000 1.06574.9029
di-Sodium hydrogénophosphate heptahydraté, EMPROVE® ESSENTIAL USP, DAC suitable for use as excipient, SAFC®
di-Sodium hydrogénophosphate heptahydraté

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 DAC, USP

Formule: HNa₂O₄P·7H₂O
MW: 268.07 g/mol
Point de fusion: 48
Densité: 1.7 g/cm³ (20 °C)
Température de stockage: Température ambiante
Numéro MDL: MFCD00149180
Numéro CAS: 7782-85-6
EINECS: 231-448-7

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Résultats des tests de spécification

Assay (alkalimetric, calculated on dried substance) 98.0 - 100.5 %
Identity passes test
Appearance of solution passes test
Insoluble substances ≤ 0.4 %
pH-value (5 %; water) 8.7 - 9.3
Sodium Dihydrogene phospate (NaH₂PO₄) passes test
Chloride (Cl) ≤ 0.0200 %
Sulfate (SO₄) ≤ 0.0500 %
Heavy metals (as Pb) ≤ 0.0010 %
As (Arsenic) ≤ 0.0002 %
Fe (Iron) ≤ 0.0020 %
Residual solvents (ICH Q3C) excluded by manufacturing process
Reducing substances passes test
Loss on drying (130 °C) 45.0 - 49.0 %


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