Peróxido de hidrogeno 30% Stabilised, EMPROVE® ESSENTIAL USP, Ph. Eur., BP suitable for use as excipient, SAFC®
Proveedor: MERCK PRODUCTION CHEMICALS
|
Peligro
|
Estabilización:
stab
1.08597.1000
1.08597.2500
1.08597.9025
1.08597.9950
1.08597.1000EA
75.1
EUR
1.08597.1000
1.08597.2500
1.08597.9025
1.08597.9950
Peróxido de hidrogeno 30% Stabilised, EMPROVE® ESSENTIAL USP, Ph. Eur., BP suitable for use as excipient, SAFC®
Peróxido de hidrogeno
Contains 0,015 % Na₂H₂P₂O₇, 0,01 % H₃PO₄, 0,006 % NH₄NO₃ as preservatives.
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, USP.
Formula:
H₂O₂ MW: 34.01 g/mol Pto. Ebullición: ∼107 °C (1013 hPa) Pto. de fusión: < 0 °C Densidad: 1.11 g/cm³ (20 °C) Temperatura de almacenaje: Ambiente |
Número MDL:
MFCD00011333 Núm. CAS: 7722-84-1 EINECS: 231-765-0 UN: 2014 ADR: 5.1 (8) II Índice Merck: 14,04798 |
Resultados test especificaciones
Assay (manganometric) | 29.0 - 31.0 % |
Identity | passes test |
Acidity (according to Ph Eur) | passes test |
Acidity (according to USP) | passes test |
Chloride (Cl) | ≤ 0.005 % |
Phosphate (PO₄) | ≤ 0.05 % |
Heavy metals (as Pb) | ≤ 0.0005 % |
As (Arsenic) | ≤ 0.0003 % |
Cu (Copper) | ≤ 0.002 % |
Pb (Lead) | ≤ 0.001 % |
Pd (Palladium)* | ≤ 0.0001 % |
Pt (Platinum)* | ≤ 0.0001 % |
Zn (Zinc) | ≤ 0.002 % |
Residual solvents (ICH Q3C) | ...excluded by production process |
Organic stabilizers | ≤ 0.045 % |
Non volatile matter (105 °C) | ≤ 0.018 % |
Preservatives | 0.015% Na₂H₂P₂O₇; 0.01% H₃PO₄; 0.006% NH₄NO₃ |
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