Potassium dihydrogen phosphate, crystallised, EMPROVE® EXPERT Ph. Eur., BP, JPC, NF for biopharmaceutical production, SAFC®

Supplier: MilliporeSigma

Synonyms: prim.-Potassium phosphateMonopotassiumphosphatePotassium dihydrogen orthophosphatePotassium phosphate monobasicMonobasic Potassium PhosphateMonopotassium phosphate

1.37039.1000 1.37039.5000 1.37039.9029 1.37039.9029 1.37039.5000
EM1.37039.9029EA 2751.93 CAD
EM1.37039.9029 EM1.37039.5000 EM1.37039.1000 CA1.37039.5000 CA1.37039.9029
Potassium dihydrogen phosphate, crystallised, EMPROVE® EXPERT Ph. Eur., BP, JPC, NF for biopharmaceutical production, SAFC®
Potassium dihydrogen phosphate

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, JPC NF

Formula: KH₂PO₄
MW: 136.09 g/mol
MDL Number: MFCD00011401
CAS Number: 7778-77-0

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Specification Test Results

Assay (alkalimetric, calculated on dried substance) 98.0 - 100.5 %
Assay (alkalimetric; dried substance) ≥ 99.0 %
Identity passes test
Appearance of solution passes test
Insoluble substances ≤ 0.2 %
pH-value (2 %; water) 4.2 - 4.6
pH-value (5 %; water) 4.2 - 4.5
Carbonate passes test
Condensed phosphate passes test
Chloride (Cl) ≤ 0.009 %
Fluoride (F) ≤ 0.0010 %
Sulfate (SO₄) ≤ 0.017 %
Heavy metals (as Pb) ≤ 0.0010 %
Al (Aluminium) ≤ 0.0005 %
As (Arsenic) ≤ 0.0002 %
Fe (Iron) ≤ 0.0010 %
Na (Sodium) ≤ 0.1 %
0 passes test
Pb (Lead) ≤ 0.0004 %
Endotoxins ≤ 2.5 I.U./g
Total aerobic microbial count ≤ 100 CFU/g
Total yeast and mould count ≤ 100 CFU/g
DNases (Exo- and endonucleases) (not detectable) passes test
RNases (not detectable) passes test
Proteases (not detectable) passes test
Residual solvents (ICH Q3C) excluded by manufacturing process
Reducing substances passes test
Loss on drying (105 °C) ≤ 0.5 %
Loss on drying (130 °C) ≤ 1.0 %

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