, anhydrous 98,0, EMPROVE® ESSENTIAL Ph. Eur., E340 suitable for use as excipient, SAFC®
Proveedor: MERCK PRODUCTION CHEMICALS
Sinónimos:
Potasio fosfato disódico
1.05101.1000
1.05101.5000
1.05101.9525
1.05101.9029
1.05101.1000EA
243
EUR
1.05101.1000
1.05101.5000
1.05101.9525
1.05101.9029
, anhydrous 98,0, EMPROVE® ESSENTIAL Ph. Eur., E340 suitable for use as excipient, SAFC®
di-Potasio hidrogenofosfato
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 (*).
Corresponds to Ph Eur, BP, E 340
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
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Formula:
K₂HPO₄ MW: 174.18 g/mol Pto. de fusión: 340 Densidad: 2.44 g/cm³ (20 °C) Temperatura de almacenaje: Ambiente |
Número MDL:
MFCD00011383 Núm. CAS: 7758-11-4 EINECS: 231-834-5 Índice Merck: 13,07743 |
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Resultados test especificaciones
| Assay (alkalimetric, calculated on dried substance) | 98.0 - 101.0 % |
| Assay (out of dried substance) | ≥ 98.0 % |
| Identity | passes test |
| Appearance of solution | passes test |
| In water insoluble matter | ≤ 0.2 % |
| pH-value (1 %, water) | 8.7 - 9.4 |
| Chloride (Cl) | ≤ 0.02 % |
| Fluoride (F) | ≤ 0.0010 % |
| Sulfate (SO₄) | ≤ 0.1 % |
| Heavy metals (as Pb) | ≤ 0.0010 % |
| Al (Aluminium) | ≤ 0.0005 % |
| As (Arsenic) | ≤ 0.0001 % |
| Cd (Cadmium) | ≤ 0.0001 % |
| Fe (Iron) | ≤ 0.0010 % |
| Hg (Mercury) | ≤ 0.0001 % |
| Na (Sodium) | ≤ 1.5 % |
| Pb (Lead) | ≤ 0.0001 % |
| Potassium dihydrogen phosphate | ≤ 2.5 % |
| Residual solvents (ICH Q3C) | excluded by manufacturing process |
| Reducing substances | passes test |
| Loss on drying (130 °C) | ≤ 2.0 % |
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