Sodio fosfato bibasico diidrato 98,0-101,0 Dry_basis, EMPROVE® ESSENTIAL BP, Ph. Eur., USP suitable for use as excipient, SAFC®
Fornitore: MERCK PRODUCTION CHEMICALS
Synonyms:
sec-Sodium phosphate, Sodium monohydrogen phosphate dihydrate, Sodium hydrogenphosphate dihydrate, di-Sodium hydrogen orthophosphate dihydrate, Sodium phosphate dibasic dihydrate, Disodium phosphate, di-Sodium hydrogen phosphate dihydrate, Sorensen's salt
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 (*).
Certificazioni: Corresponds to Ph. Eur., BP, USP.
Formula:
Na₂HPO₄·2H₂O Peso molecolare: 177.99 g/mol Punto di fusione: 92.5 Densità: 2.1 g/cm³ (20 °C) Temperatura di stoccaggio: Ambiente |
MDL Number:
MFCD00149182 CAS Number: 10028-24-7 EINECS: 231-448-7 |
Risultati del test di specificazione
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% |
Identity | Passes Test |
Appearance of Solution | Passes Test |
In Water Insoluble Matter | ≤0.3% |
pH-Value (5%; Water) | 8.9 - 9.2 |
Chloride (Cl) | ≤0.005% |
Sulfate (SO₄) | ≤0.02% |
Heavy Metals (as Pb) | ≤0.001% |
As (Arsenic) | ≤0.0002% |
Fe (Iron) | ≤0.001% |
Sodium Dihydrogen Phosphate (NaH₂PO₄) | ≤1.7% |
Residual Solvents (ICH Q3C) | Excluded by Manufacturing Process |
Substances Reducing Potassium Permanganate (as O) | Passes Test |
Loss on drying (130 °C) | 19.5 - 21.0 % |
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