Sodium chloride, EMPROVE® EXPERT USP, JP, Ph. Eur., BP for biopharmaceutical production, SAFC®
: Saline, NaCl, Sea salt, Halite
:7647-14-5
:
:NaCl
:MFCD00003477
:1461 °C (1013 hPa)
:801
:2.17 g/cm3 (20 °C)
:58.44 g/mol
:14,08599
:Ambient
:231-598-3
- Environmentally Preferable:
- 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
- Microbiological purity (Total aerobic microbial count (TAMC)):≤ 100.0 CFU/g
- Microbiological purity (Total yeast and mould count (TYMC)):≤ 100.0 CFU/g
- DNases (Exo- and endonucleases) (not detectable):passes test
- RNases (not detectable):passes test
- Proteases (not detectable):passes test
- Nicking Activity (not detectable):passes test
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