Sodium hydroxide 1 mol/l, EMPROVE® EXPERT for biopharmaceutical production, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS
Danger

Synonyms: Caustic soda

1.37031.2500 1.37031.9025 1.37031.5000 1.37031.1002 1.37031.9200 1.37031.9208 1.37031.9958
1.37031.2500EA 394 GBP
1.37031.2500 1.37031.9025 1.37031.5000 1.37031.1002 1.37031.9200 1.37031.9208 1.37031.9958
Sodium hydroxide 1 mol/l, EMPROVE® EXPERT for biopharmaceutical production, SAFC®
Sodium hydroxide
Formula: NaOH
MW: 40 g/mol
Boiling Pt: 1390
Melting Pt: 323
Density: 1.04 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

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Specification Test Results

Assay (Acidimetric, NaOH) 0.99 - 1.01 mol/l
Carbonate (as Na₂CO₃) ≤1.0%
Chloride (Cl) ≤5 ppm
Sulfate (SO₄) ≤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
Total Aerobic Microbial Count (TAMC) ≤100 CFU/g
Total Combined Yeasts/Moulds Count (TYMC) ≤10 CFU/g
Filtered with 0.2 µm
This product is 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 (*).


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