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Cloreto de sódio, EMPROVE® EXPERT Ph. Eur., BP, JP, USP para produção biofarmacêutica, SAFC®

Fornecedor: MERCK PRODUCTION CHEMICALS

1.37017.5000 1.37017.9012 1.37017.9029 1.37017.1000
1.37017.5000EA 268 EUR
1.37017.5000 1.37017.9012 1.37017.9029 1.37017.1000
Cloreto de sódio, EMPROVE® EXPERT Ph. Eur., BP, JP, USP para produção biofarmacêutica, SAFC®
Cloreto de Sódio

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 (*).

Fórmula: NaCl
Ponto de ebulição: 1461 °C (1013 hPa)
Ponto de Fusão: 801 °C
Densidade: 2,17 g/cm3 (20 °C)
Temperatura de Armazenamento: Ambiente
Número MDL : MFCD00003477
Número CAS: 7647-14-5
EINECS: 231-598-3
Merck Index: 14,08599

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Especificações dos Resultados do Teste

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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