TRITON™ X-100, EMPROVE® EXPERT Ph. Eur. para producción biofarmacéutica, SAFC®

Proveedor: MERCK PRODUCTION CHEMICALS
Peligro

Sinónimos: Polyethyleneglycol-[4-(1,1,3,3-tetramethylbutyl)phenyl]-ether, (p-tert-Octylphenoxy)polyethoxyethanol, Octoxynol, Polyoxyethylene(10) Octylphenyl Ether, t-Octylphenoxypolyethoxyethanol, O-[4-(1,1,3,3-Tetramethylbutyl)phenoxy]polyethoxyethanol

1.08643.6190 1.08643.1000 1.08643.2500 1.08643.6025
1.08643.6190EA 0 EUR
1.08643.6190 1.08643.1000 1.08643.2500 1.08643.6025
TRITON™ X-100, EMPROVE® EXPERT Ph. Eur. para producción biofarmacéutica, SAFC®
TRITON™ X-100

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 (*).


Certificaciones: Corresponds to Octoxinol Ph. Eur.

Pto. Ebullición: ∼200 °C (1013 hPa)
Pto. de fusión: 6
Densidad: 1.06 g/cm³ (20 °C)
Pto. de inflamación: 251 °C (copa cerrada)
Temperatura de almacenaje: Nevera
Número MDL: MFCD00132505
Núm. CAS: 9002-93-1
UN: 3082
ADR: 9 III
Índice Merck: 13,06793

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Resultados test especificaciones

Assay (HPLC) 90.0 - 110.0 %
Identity (IR-spectrum) passes test
Identity (Cloud point) passes test
Appearance Almost clear, almost colorless to sligthly yellowish liquid (≤ 100 Hazen).
Density (d 20/4) 1.064 - 1.067
Acidity or alkalinity passes test
pH-value (10 g/l in KCl(1g/l)) 6.0 - 8.0
Cloud point 63 - 69 °C
Chloride (Cl) ≤ 50 ppm
Phosphate (PO₄) ≤ 1000 ppm
Sulfate (SO₄) ≤ 50 ppm
Heavy metals (as Pb) ≤ 10 ppm
K (Potassium) ≤ 1000 ppm
Na (Sodium) ≤ 1000 ppm
Acetaldehyde (GC) ≤ 5 ppm
Dioxane (GC) ≤ 10 ppm
Ethylenglycol (GC) ≤ 620 ppm
Ethylene oxide (GC) ≤ 1 ppm
Formaldehyde ≤ 5 ppm
Average number of oxyethylene moieties (H-NMR) 43747
Other residual solvents (ICH Q3C) passes test
Hydroxyl value 85 - 101
Ash (600 °C) ≤ 0.2
Sulfated ash (600 °C) ≤ 0.4
Water (according to Karl Fischer) ≤ 0.2
Bacterial endotoxins ≤ 100 I.U./ml
TAMC (Total aerobic microbial count) ≤ 10²
TYMC (Total yeast and mould count) ≤ 10²


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