di-Natriumhydrogenphosphat, anhydrous 98,0-100,5 Acidometric titration, EMPROVE® ESSENTIAL USP, Ph. Eur., BP, JPE suitable for use as excipient, SAFC®
Lieferant: MERCK PRODUCTION CHEMICALS
Synonyms:
sec-Sodium phosphate, di-Sodium hydrogen orthophosphate, di-Sodium hydrogen phosphate anhydrous, Sodium hydrogen phosphate, Disodium phosphate, Sodium phosphate dibasic
1.06585.5000
1.06585.1000
1.06585.5000EA
670
CHF
1.06585.5000
1.06585.1000
di-Natriumhydrogenphosphat, anhydrous 98,0-100,5 Acidometric titration, EMPROVE® ESSENTIAL USP, Ph. Eur., BP, JPE suitable for use as excipient, SAFC®
di-Natriumhydrogenphosphat
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 (*).
Zertifizierungen: Corresponds to Ph Eur, BP, USP, JPE, E 339
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
|
Formel:
Na₂HPO₄ MW: 141.96 g/mol Melting Pt: 250 Dichte: 1.53 g/cm³ (20 °C) Lager Temperatur: Raumtemperatur |
MDL Number:
MFCD00003496 CAS-Nummer: 7558-79-4 EINECS: 231-448-7 REACH: 01-2119489797-11 Merck Index: 12,08805 |
Spezifikation Testergebnisse
| Assay (calculated on dried substance according to Ph Eur) | 98.0 - 101.0 % |
| Assay (calculated on dried substance according to USP) | 98.0 - 100.5 % |
| Assay (acidimetric; dried substance) | 99.0 - 101.0 % |
| Identity | passes test |
| Appearance of solution | passes test |
| In water insoluble matter (calculated on dried substance) | ≤ 0.20 % |
| Sodium dihydrogen phosphate (NaH₂PO₄) | ≤ 1.7 % |
| pH-value (1 %, water) | 9.0 - 9.4 |
| Carbonate | passes test |
| Chloride (Cl) | ≤ 0.01 % |
| Fluoride (F) | ≤ 0.001 % |
| Sulfate (SO₄) | ≤ 0.03 % |
| Heavy metals (as Pb) | ≤ 0.001 % |
| As (Arsenic) | ≤ 0.0001 % |
| Cd (Cadmium) | ≤ 0.0001 % |
| Fe (Iron) | ≤ 0.002 % |
| Hg (Mercury) | ≤ 0.0001 % |
| Ni (Nickel)* | ≤ 0.0002 |
| Pb (Lead) | ≤ 0.0001 % |
| Residual solvents (ICH Q3C) | excluded by production process |
| Substances reducing potassium permanganate | passes test |
| Loss on drying (130 °C) | ≤ 1.0 % |
| Particle size (< 0.315 mm) | about 99 % |
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