Hidróxido de sódio 10 mol/l, EMPROVE® EXPERT para produção biofarmacêutica, SAFC®
Fornecedor: MERCK PRODUCTION CHEMICALS
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Perigo
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Filtrado através de um filtro de 0,2 µm
- Store above +15°C
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 (*).
Fórmula:
NaOH Ponto de ebulição: 109 °C (1013 hPa) Densidade: 1,33 g/cm3 (20 °C) Temperatura de Armazenamento: Frigorífico |
Número MDL :
MFCD00003548 Número CAS: 1310-73-2 EINECS: 215-185-5 UN: 1824 ADR: 8,II |
Especificações dos Resultados do Teste
Assay (acidimetric,NaOH) | 9.9 - 10.1 mol/l |
Assay (acidimetric) | 29.9 - 30.3 % |
Identity | passes test |
Carbonate (as Na₂CO₃) | ≤ 1.0 % |
Chloride (Cl) | ≤ 20 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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