di-Natriumhydrogen fosfat dihydrat, EMPROVE® EXPERT Ph. Eur., BP, USP, SAFC®
Leverantör: 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 (*).
Certifikat: Corresponds to Ph Eur, BP, USP
Formel:
Na₂HPO₄·2H₂O MW: 177,99 g/mol Smältpunkt: 92,5 °C Densitet: 2,1 g/cm³ (20 °C) Storage Temperature: Omgivande |
MDL Number:
MFCD00149182 CAS nummer: 10028-24-7 EINECS: 231-448-7 |
Specifikation testresultat
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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