Sodium hydroxyde 10 mol/l, EMPROVE® EXPERT BiopharmaceuticalProduction, SAFC®
Fournisseur: MERCK PRODUCTION CHEMICALS
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Danger
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Synonyms:
Caustic soda
Filter 0,2 um
- 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 (*).
Formule:
NaOH MW: 40 g/mol Point d'ébullition: 1390 Point de fusion: 323 Densité: 1.33 g/cm3 (20 °C) Température de stockage: Réfrigérateur |
Numéro MDL:
MFCD00003548 Numéro CAS: 1310-73-2 EINECS: 215-185-5 ONU: 1824 ADR: 8 II Merck Index: 14,08627 |
Résultats des tests de spécification
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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