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Potassio diidrogeno fosfato, EMPROVE® EXPERT JPC, NF, Ph. Eur., BP BiopharmaceuticalProduction, SAFC®

Fornitore: MERCK PRODUCTION CHEMICALS

Synonyms: Potassio fosfato monobasico

1.37039.5000 1.37039.9029
1.37039.5000EA 747 EUR
1.37039.5000 1.37039.9029
Potassio diidrogeno fosfato, EMPROVE® EXPERT JPC, NF, Ph. Eur., BP BiopharmaceuticalProduction, SAFC®
Potassio diidrogeno fosfato

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
Peso molecolare: 136.09 g/mol
Punto di ebollizione: ∼100 °C (1013 hPa)
Punto di fusione: 253
Densità: 2.3 g/cm³ (20 °C)
Temperatura di stoccaggio: Ambiente
MDL Number: MFCD00011401
CAS Number: 7778-77-0
EINECS: 231-913-4
REACH: 01-2119490224-41
Merck Index: 13,07744

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Risultati del test di specificazione

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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