Sodio cloruro, EMPROVE® EXPERT USP, JP, Ph. Eur., BP para producción biofarmacéutica, SAFC®
Proveedor: MERCK PRODUCTION CHEMICALS
Sinónimos:
Saline, NaCl, Sea salt, Halite
1.37017.5000
1.37017.9012
1.37017.9029
1.37017.1000
1.37017.5000EA
309
EUR
1.37017.5000
1.37017.9012
1.37017.9029
1.37017.1000
Sodio cloruro, EMPROVE® EXPERT USP, JP, Ph. Eur., BP para producción biofarmacéutica, SAFC®
Sodio cloruro
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 (*).
|
Formula:
NaCl Pto. Ebullición: 1461 °C (1013 hPa) Pto. de fusión: 801 °C Densidad: 2,17 g/cm3 (20 °C) Temperatura de almacenaje: Ambiente |
Número MDL:
MFCD00003477 Núm. CAS: 7647-14-5 EINECS: 231-598-3 Índice Merck: 14,08599 |
Resultados test especificaciones
| 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 |
| Corresponds to Ph Eur,BP,JP,USP |
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