Sodium hydroxyde 0.1 mol/L en solution aqueuse, EMPROVE® EXPERT pour production biopharmaceutique
Fournisseur: MERCK PRODUCTION CHEMICALS
Filtered through a 0.2 µm filter.
This product has been manufactured from Sodium hydroxide pellets Ph Eur, BP, JP, NF and waterfor injection (wfi) ace. USP which conforms with highly purified water (hpw) ace. Ph Eur.
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elementallmpurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Formule:
NaOH Densité: 1 g/cm³ (25 °C) Température de stockage: Température ambiante |
Numéro MDL:
MFCD00003548 Numéro CAS: 1310-73-2 EINECS: 215-185-5 ONU: 1824 ADR: 8, |
Résultats des tests de spécification
Assay (acidimetric,NaOH) | 0.05- 0.15 mol/l |
Carbonate (as Na2CO3) | ≤ 0.2% |
Chloride (Cl) | ≤ 5% |
Sulfate (SO.) | ≤ 30 ppm |
Heavy metals (as Pb) | ≤ 5.0 ppm |
Al (Aluminium) | ≤ 10 ppm |
Fe (Iron) | ≤ 3 ppm |
Residual solvents (ICH Q3C) | excluded by production process |
Endotoxins | ≤ 2.0 I.U./ml |
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