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
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 |
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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