TRITON™ X-100 (Polyethylene glycol tert-octylphenyl ether), EMPROVE® EXPERT Ph. Eur. for biopharmaceutical production, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS
Danger

Synonyms: (p-tert-Octylphenoxy)polyethoxyethanolO-[4-(1,1,3,3-Tetramethylbutyl)phenoxy]polyethoxyethanolOctoxynolPolyethyleneglycol-[4-(1,1,3,3-tetramethylbutyl)phenyl]-ether

1.08643.2500EA 3630 EUR
1.08643.2500 1.08643.6190 1.08643.6025 1.08643.1000
TRITON™ X-100 (Polyethylene glycol tert-octylphenyl ether), EMPROVE® EXPERT Ph. Eur. for biopharmaceutical production, SAFC®
TRITON™ X-100 (Polyethylene glycol tert-octylphenyl ether)

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 Octoxinol Ph. Eur.

Boiling Pt: ∼200 °C (1013 hPa)
Melting Pt: 6 °C
Density: 1,06 g/cm³ (20 °C)
Flash Pt: 251 °C (closed cup)
Storage Temperature: Refrigerator
MDL Number: MFCD00132505
CAS Number: 9002-93-1
UN: 3082
ADR: 9,III
Merck Index: 13,06793

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Specification Test Results

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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