Sodio idrossido 10 mol/l, EMPROVE® EXPERT per la produzione biofarmaceutica, SAFC®
Fornitore: MERCK PRODUCTION CHEMICALS
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Pericolo
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filtrato a 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 (*).
Formula:
NaOH Punto di ebollizione: 109 °C (1013 hPa) Densità: 1,33 g/cm3 (20 °C) Temperatura di stoccaggio: Refrigerata |
MDL Number:
MFCD00003548 CAS Number: 1310-73-2 EINECS: 215-185-5 UN: 1824 ADR: 8,II |
Risultati del test di specificazione
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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