Sodio hidróxido solución 32% (by acidimetry), EMPROVE® EXPERT para producción biofarmacéutica, SAFC®
Proveedor: MERCK PRODUCTION CHEMICALS
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Peligro
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Filtrado por 0,2 µm
This product has been manufactured from Sodium hydroxide pellets Ph Eur, BP, JP, NF and water for injection (wfi) acc. USP which conforms with highly purified water (hpw) acc. Ph Eur.
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 (*).
Formula:
NaOH Pto. Ebullición: 119…135 °C (1013 hPa) Pto. de fusión: 9…10 °C Densidad: 1,53 g/cm³ (20 °C) Temperatura de almacenaje: Ambiente |
Número MDL:
MFCD00003548 Núm. CAS: 1310-73-2 EINECS: 215-185-5 UN: 1824 ADR: 8, |
Resultados test especificaciones
Assay (acidimetric,NaOH) | 32.0 - 33.0 % |
Carbonate (as Na₂CO₃) | ≤ 1.0 % |
Chloride (Cl) | ≤ 5 ppm |
Sulfate (SO₄) | ≤ 30 ppm |
Heavy metals (as Pb) | ≤ 5.0 ppm |
Al (Aluminium) | ≤ 10 ppm |
Fe (Iron) | ≤ 3 ppm |
Ni (Nickel) * | ≤ 2.00 ppm |
Residual solvents (ICH Q3C) | ...excluded by production process |
Endotoxins | ≤ 2.0 I.U./ml |
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