Imprimer

Potassium dihydrogénophosphate, EMPROVE® EXPERT JPC, NF, Ph. Eur., BP BiopharmaceuticalProduction, SAFC®

Fournisseur: MERCK PRODUCTION CHEMICALS

Synonyms: Monopotassiumphosphate, prim.-Potassium phosphate, Monopotassium phosphate, Potassium phosphate monobasic, Monobasic Potassium Phosphate, Potassium dihydrogen orthophosphate

1.37039.5000 1.37039.9029
1.37039.5000EA 499 EUR
1.37039.5000 1.37039.9029
Potassium dihydrogénophosphate, EMPROVE® EXPERT JPC, NF, Ph. Eur., BP BiopharmaceuticalProduction, SAFC®
Potassium dihydrogénophosphate

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

Formule: KH₂PO₄
MW: 136.09 g/mol
Point d'ébullition: ∼100 °C (1013 hPa)
Point de fusion: 253
Densité: 2.3 g/cm³ (20 °C)
Température de stockage: Température ambiante
Numéro MDL: MFCD00011401
Numéro CAS: 7778-77-0
EINECS: 231-913-4
ATTEINDRE: 01-2119490224-41
Merck Index: 13,07744

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Résultats des tests de spécification

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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