Sodium hydroxide 0.1 mol/L in aqueous solution, EMPROVE® EXPERT for biopharmaceutical production, SAFC®
Supplier: MilliporeSigma
Synonyms:
Caustic soda
Filtered through a 0.2 µm filter.
Suitable for biopharmaceutical production.
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 (*).
Formula:
NaOH MW: 40 g/mol Boiling Pt: 1390 Melting Pt: 323 Density: 1 g/cm³ (25 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00003548 CAS Number: 1310-73-2 EINECS: 215-185-5 UN: 1824 ADR: 8 Merck Index: 14,08627 |
Specification Test Results
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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