Potasio dihidrogenofosfato, EMPROVE® ESSENTIAL JPC, NF, Ph. Eur., BP, E340 suitable for use as excipient, SAFC®

Proveedor: MERCK PRODUCTION CHEMICALS

Sinónimos: Potasio fosfato monobásico

1.04871.1000 1.04871.5000 1.04871.9050 1.04871.9029
1.04871.1000EA 147 EUR
1.04871.1000 1.04871.5000 1.04871.9050 1.04871.9029
Potasio dihidrogenofosfato, EMPROVE® ESSENTIAL JPC, NF, Ph. Eur., BP, E340 suitable for use as excipient, SAFC®
Potasio dihidrogenofosfato

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 (*).


Certificaciones: Corresponds to Ph Eur, BP, JPC, NF, E 340
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

Formula: KH₂PO₄
MW: 136.09 g/mol
Pto. Ebullición: ∼100 °C (1013 hPa)
Pto. de fusión: 253
Densidad: 2.3 g/cm³ (20 °C)
Temperatura de almacenaje: Ambiente
Número MDL: MFCD00011401
Núm. CAS: 7778-77-0
EINECS: 231-913-4
IR: 01-2119490224-41
Índice Merck: 13,07744

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Resultados test especificaciones

Assay (alkalimetric, calculated on dried substance) 98.0 - 100.5 %
Assay (alkalimetric; dried substance) ≥ 99.0 %
Appearance of solution passes test
Identity passes test
Insoluble substances ≤ 0.2 %
pH-value (1 %; water) 4.2 - 4.8
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) ≤ 0.0001 %
Cd (Cadmium) ≤ 0.0001 %
Fe (Iron) ≤ 0.0010 %
Hg (Mercury) ≤ 0.0001 %
Na (Sodium) passes test
Pb (Lead) ≤ 0.0001 %
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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