di-Natriumhydrogenphosphat Dihydrat, EMPROVE® EXPERT Ph. Eur., BP, USP, SAFC®
Lieferant: MERCK PRODUCTION CHEMICALS
Synonyms:
sek. Natriumphosphat Dihydrat
, Sorensen's Salz
, Natriumphosphat dibasisch Dihydrat
1.37036.9029EA
0
CHF
1.37036.9029
1.37036.9012
1.37036.5000
di-Natriumhydrogenphosphat Dihydrat, EMPROVE® EXPERT Ph. Eur., BP, USP, SAFC®
di-Natriumhydrogenphosphat Dihydrat
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
|
Formel:
Na₂HPO₄·2H₂O MW: 177,99 g/mol Melting Pt: 92,5 °C Dichte: 2,1 g/cm³ (20 °C) Lager Temperatur: Raumtemperatur |
MDL Number:
MFCD00149182 CAS-Nummer: 10028-24-7 EINECS: 231-448-7 |
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 % |
| 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 % |
| Endotoxins | ≤ 2.5 I.U./g |
| Total aerobic microbial count | ≤ 1E+02 CFU/g |
| Total yeast and mould count | ≤ 1E+02 CFU/g |
| DNases (Exo- and endonucleases) (not detectable) | passes test |
| RNases (not detectable) | passes test |
| Proteases (not detectable) | passes test |
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