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 |
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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