, wasserfrei ≥98,0%, EMPROVE® ESSENTIAL E340, BP, Ph. Eur. suitable for use as excipient, SAFC®
Lieferant: MERCK PRODUCTION CHEMICALS
Synonyme:
di-Potassium hydrogen orthophosphate, Dipotassium hydrogenphosphate, Potassium hydrogen phosphate, Dipotassium hydrogen phosphate, Dipotassium Phosphate, Dibasic Potassium Phosphate, Potassium Phosphate, Dibasic, (dipotassium hydrogen phosphate), Potassium phosphate dibasic, Dipotassium phosphate
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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Formel:
K₂HPO₄ Schmelzpunkt: 340 °C Dichte: 2.44 g/cm³ (20 °C) Lagerungstemperatur: Raumtemperatur |
MDL Number:
MFCD00011383 CAS-Nummer: 7758-11-4 EINECS: 231-834-5 Merck Index: 13,07743 |
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Spezifikation Testergebnisse
| 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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