Sodium hydroxide 10 mol/l, EMPROVE® EXPERT for biopharmaceutical production, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS
Danger

Synonyms: Caustic soda

Filtered through a 0.2 µm filter.

4.80648.2500 4.80648.9025 4.80648.9950 4.80648.9208 4.80648.9958
4.80648.2500EA 505 GBP
4.80648.2500 4.80648.9025 4.80648.9950 4.80648.9208 4.80648.9958
Sodium hydroxide 10 mol/l, EMPROVE® EXPERT for biopharmaceutical production, SAFC®
Sodium hydroxide

  • 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
Boiling Pt: 109 °C (1013 hPa)
Density: 1,33 g/cm3 (20 °C)
Storage Temperature: Refrigerator
MDL Number: MFCD00003548
CAS Number: 1310-73-2
EINECS: 215-185-5
UN: 1824
ADR: 8,II

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Specification Test Results

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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