Ammonium sulfate 99.5-100.5% (by alkalimetry), EMPROVE® EXPERT ACS, NF for biopharmaceutical production, SAFC®

Supplier: MilliporeSigma

Synonyms: Diammonium sulfateSulphuric acid diammonium saltsulfuric acid diammonium saltDiammonium sulphateMascagnite

1.01816.1000 1.01816.9029 1.01816.9029 1.01816.9010 1.01816.9012 1.01816.9010
CA1.01816.9010EA 1084.95 CAD
CA1.01816.9010 CA1.01816.1000 EM1.01816.9029 CA1.01816.9029 EM1.01816.9012 EM1.01816.9010
Ammonium sulfate 99.5-100.5% (by alkalimetry), EMPROVE® EXPERT ACS, NF for biopharmaceutical production, SAFC®
Ammonium sulphate
Formula: (NH₄)₂SO₄
MW: 132.14 g/mol
Melting Pt: 336…339 °C
Storage Temperature: Ambient
MDL Number: MFCD00003391
CAS Number: 7783-20-2
EINECS: 231-984-1
REACH: 01-2119455044-46

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Specification Test Results

Assay (alkalimetric) 99.5 - 100.5 %
Identity passes test
Insoluble matter ≤ 0.001 %
pH-value (5 %; water, 25 °C) 5.0 - 6.0
Chloride (Cl) ≤ 0.0002 %
Nitrate (NO₃) ≤ 0.0010 %
Phosphate (PO₄) ≤ 0.0005 %
Heavy metals (ACS) ≤ 0.0005 %
Al (Aluminium) ≤ 0.000075 %
As (Arsenic) ≤ 0.00002 %
Ca (Calcium) ≤ 0.001 %
Cd (Cadmium) ≤ 0.0001 %
Cr (Chromium) ≤ 0.000075 %
Cu (Copper) ≤ 0.0001 %
Fe (Iron) ≤ 0.0002 %
Mg (Magnesium) ≤ 0.0005 %
Pb (Lead) ≤ 0.0002 %
Pt (Platinum) (*) ≤ 0.0001
Zn (Zinc) ≤ 0.0001 %
Residual solvents (ICH Q3C) excluded by manufacturing process
Residue on ignition (as sulfate) ≤ 0.005 %
Loss on Drying (105 °C) ≤ 0.1 %
Total aerobic microbial count ≤ 1000 CFU/g
Total yeast and mould count ≤ 10 CFU/g
Salmonella species (absent in 10 g) passes test
E. coli (absent in 1 g) passes test
Staphylococcus aureus (absent in 1 g) passes test
Pseudomonas aeruginosa (absent in 1 g) passes test
Candida albicans (absent in 1 g) passes test
Endotoxins ≤ 2.5 I.U./g
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 (*).
Corresponds to ACS,NF

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