di-Potassium hydrogen phosphate, anhydrous 98.0-100.5% (alkalimetric, calculated on anhydrous substance), EMPROVE® api Ph. Eur., BP, USP low sodium, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS

Synonyms: di-Potassium hydrogen orthophosphateDibasic Potassium PhosphatePotassium phosphate dibasicPotassium Phosphate, Dibasic, (dipotassium hydrogen phosphate)Potassium hydrogen phosphateDipotassium hydrogen phosphate

1.09828.1000EA 412 EUR
1.09828.1000 1.09828.0001S
di-Potassium hydrogen phosphate, anhydrous 98.0-100.5% (alkalimetric, calculated on anhydrous substance), EMPROVE® api Ph. Eur., BP, USP low sodium, SAFC®
di-Potassium hydrogen phosphate
Formula: K₂HPO₄
MW: 174,18 g/mol
Melting Pt: 340 °C
Density: 2,3 g/cm³ (20 °C)
Storage Temperature: Ambient
MDL Number: MFCD00011383
CAS Number: 7758-11-4
EINECS: 231-834-5
Merck Index: 12,07828
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Specification Test Results

Assay (alkalimetric, calculated on dried substance) 98.0 - 100.5 %
Identity passes test
Appearance of solution passes test
Insoluble substances ≤ 0.2 %
pH-value (5 %; water) 8.5 - 9.6
Carbonate passes test
Chloride (Cl) ≤ 0.02 %
Fluoride (F) ≤ 0.001 %
Sulfate (SO₄) ≤ 0.1 %
Heavy metals (as Pb) ≤ 0.0010 %
Al (Aluminium) ≤ 0.0003 %
As (Arsenic) ≤ 0.0002 %
Fe (Iron) ≤ 0.0010 %
Na (Sodium) ≤ 0.1 %
Na (sodium) passes test
Potassium dihydrogen phosphate ≤ 2.5 %
Potassium dihydrogen phosphate and tri- Potassium phosphate passes test
Residual solvents (ICH Q3C) excluded by manufacturing process
Reducing substances passes test
Loss on drying (130 °C) ≤ 1.0 %
Total aerobic microbial count ≤ 500 CFU/g
Bacterial endotoxins < 1.1
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 (*).
Corresponds to Ph Eur, BP, USP

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