Ammonium sulfate 99.5-100.5% (by alkalimetry), EMPROVE® EXPERT ACS, NF for biopharmaceutical production, SAFC®
Supplier: MilliporeSigma
Synonyms:
Diammonium sulfate
, Sulphuric acid diammonium salt
, sulfuric acid diammonium salt
, Diammonium sulphate
, Mascagnite
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 |
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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