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Dihidrogenoortofosfato de potássio, EMPROVE® EXPERT JPC, NF, Ph. Eur., BP BiopharmaceuticalProduction, SAFC®

Fornecedor: MERCK PRODUCTION CHEMICALS

Sinônimos: 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
Dihidrogenoortofosfato de potássio, EMPROVE® EXPERT JPC, NF, Ph. Eur., BP BiopharmaceuticalProduction, SAFC®
Dihidrogenoortofosfato de potássio

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

Fórmula: KH₂PO₄
Peso Molecular: 136.09 g/mol
Ponto de ebulição: ∼100 °C (1013 hPa)
Ponto de Fusão: 253
Densidade: 2.3 g/cm³ (20 °C)
Temperatura de Armazenamento: Ambiente
Número MDL : MFCD00011401
Número CAS: 7778-77-0
EINECS: 231-913-4
ALCANCE: 01-2119490224-41
Merck Index: 13,07744

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Especificações dos Resultados do Teste

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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