Sodium carbonate, anhydrous 99.5-100.5% (by acidimetry), EMPROVE® EXPERT Ph. Eur., BP, JP, NF for biopharmaceutical production, SAFC®

Supplier: EMD MILLIPORE – PCS CA EXCEP
Warning

Synonyms: Calcined sodaCarbonic acid disodium salt

1.37014.5000 1.37014.9029 1.37014.9029 1.37014.5000
CA1.37014.5000EA 653.33 CAD
CA1.37014.5000 EM1.37014.9029 EM1.37014.5000 CA1.37014.9029
Sodium carbonate, anhydrous 99.5-100.5% (by acidimetry), EMPROVE® EXPERT Ph. Eur., BP, JP, NF for biopharmaceutical production, SAFC®
Sodium carbonate

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.


Certifications: Meets the specifications of Ph. Eur., BP, JP, NF.

Formula: Na₂CO₃
MW: 105.99 g/mol
Melting Pt: 854 °C
Density: 2.53 g/cm³ (20 °C)
Storage Temperature: Ambient
MDL Number: MFCD00003494
CAS Number: 497-19-8
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Specification Test Results

Assay (Acidimetric; Calculated on Dried Substance) 99.5 - 100.5 %
Appearance of Solution Passes Test
Identity Passes Test
Chloride (Cl) ≤0.0125%
Sulfate (SO₄) ≤0.025%
Heavy metals (as Pb) ≤0.001%
As (Arsenic) ≤0.00031%
Fe (Iron) ≤0.0050%
Alkali Hydroxides and Alkali Hydrogen Carbonates Passes Test
Residual Solvents (Ph. Eur./USP/ICH) Excluded by Manufacturing Process
Loss on Drying (300 °C) ≤0.5%
Endotoxins ≤2.5 I.U./g
Total Aerobic Microbial Count ≤100 CFU/g
Total Yeast and Mould Count ≤100 CFU/g

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