Sodium chloride 99.5-100.5% (by argentometric analysis, on dry substance), EMPROVE® EXPERT Ph. Eur., BP, JP, USP suitable for use as excipient low in endotoxins, SAFC®
Supplier: EMD MILLIPORE – PCS CA EXCEP
Synonyms:
Halite
, Sea salt
, NaCl
, Saline
1.16224.9500
1.16224.5000
1.16224.9029
1.16224.9029
1.16224.9053
1.16224.9500
1.16224.9053
CA1.16224.9029EA
795.83
CAD
CA1.16224.9029
EM1.16224.9053
CA1.16224.9053
EM1.16224.9500
EM1.16224.5000
EM1.16224.9029
CA1.16224.9500
Sodium chloride 99.5-100.5% (by argentometric analysis, on dry substance), EMPROVE® EXPERT Ph. Eur., BP, JP, USP suitable for use as excipient low in endotoxins, SAFC®
Sodium chloride
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 (*).
Certifications: Corresponds to Ph. Eur., BP, JP, USP
Formula:
NaCl MW: 58.44 g/mol Boiling Pt: 1461 °C (1013 hPa) Melting Pt: 801 °C Density: 2.17 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00003477 CAS Number: 7647-14-5 |
Specification Test Results
Assay (argentometric; calculated on dried substance) | 99.5 - 100.5 % |
Identity | passes test |
Appearance of solution | passes test |
Acidity or alkalinity | passes test |
Bromide (Br) | ≤ 0.005 % |
Ferrocyanides | passes test |
Iodide (I) | passes test |
Nitrite (NO₂) (UV-absorption 354nm; 1cm; 10%; water) | ≤ 0.01 |
Phosphate (PO₄) | ≤ 0.0025 % |
Sulfate (SO₄) | ≤ 0.0200 % |
Heavy metals (as Pb) | ≤ 0.0003 % |
Al (Aluminium) | ≤ 0.00002 % |
As (Arsenic) | ≤ 0.0001 % |
Ba (Barium) | passes test |
Ca (Calcium) | ≤ 0.002 % |
Fe (Iron) | ≤ 0.0002 % |
K (Potassium) | ≤ 0.01 % |
Magnesium and alkaline-earth metals (as Ca) | ≤ 0.0100 % |
Residual solvents (ICH Q3C) | excluded by production process |
Loss on drying (105 °C, 2 h) | ≤ 0.5 % |
Endotoxins (kinetic turbidimetric test) | ≤ 2.5 I.U./g |
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