Potassium dihydrogen phosphate, crystallised, EMPROVE® EXPERT Ph. Eur., BP, JPC, NF for biopharmaceutical production, SAFC®
Supplier: MilliporeSigma
Synonyms:
prim.-Potassium phosphate
, Monopotassiumphosphate
, Potassium dihydrogen orthophosphate
, Potassium phosphate monobasic
, Monobasic Potassium Phosphate
, Monopotassium 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 |
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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