Disodium hydrogen phosphate dihydrate, EMPROVE® EXPERT Ph. Eur., BP, USP, SAFC®
Supplier: MERCK PRODUCTION CHEMICALSTotal Ratings: 0
Avg. Ratings: 0.0 out of 5
Synonyms:
Sodium hydrogenphosphate dihydrate
, Sorensen's salt
, sec-Sodium phosphate
, di-Sodium hydrogen orthophosphate dihydrate
, Disodium phosphate
, Sodium phosphate dibasic dihydrate
, di-Sodium hydrogen phosphate dihydrate
, Sodium monohydrogen phosphate dihydrate
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 (*).
Certifications: Corresponds to Ph Eur, BP, USP
Formula:
Na₂HPO₄·2H₂O MW: 177.99 g/mol Melting Pt: 92.5 °C Density: 2.1 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00149182 CAS Number: 10028-24-7 EINECS: 231-448-7 |
Specification Test Results
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 |
Learn more
About VWR
Avantor is a vertically integrated, global supplier of discovery-to-delivery solutions for...