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Triton X-100

EMPROVE® EXPERT Ph Eur

Synonym: Octoxynol, (p-tert-Octylphenoxy)polyethoxyethanol, O-[4-(1,1,3,3-Tetramethylbutyl)phenoxy]polyethoxyethanol, Polyethyleneglycol-[4-(1,1,3,3-tetramethylbutyl)phenyl]-ether, Triton X-100

  • CAS Number 9036-19-5

  • Linear Formula C8H17C6H4(OCH2CH2)nOH

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biochemicals and Reagents, Biomolecule Liquid Dosage Forms, Biopharmaceutical Manufacturing, Biopharmaceutical Process Development and Manufacturing,
Quality Level   500
grade   Ph Eur
vapor pressure   <0.01 hPa ( 20 °C)
potency   1900-5000 mg/kg LD50, oral (Rat)
  >3000 mg/kg LD50, skin (Rabbit)
pH   5.0-8.0 (20 °C, 10 g/L in H2O)
bp   >200 °C/1013 hPa
transition temp   flash point 251 °C
density   1.07 g/cm3 at 20 °C
storage conditions   Store at +15°C to +25°C.

Description

Analysis Note

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): 9 - 10
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
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 (*).
Corresponds to Octoxinol Ph. Eur.

Legal Information

Triton is a trademark of The Dow Chemical Company or an affiliated company of Dow

Safety & Documentation

Safety Information

Symbol 
GHS05  GHS05
Signal word 
Danger
Hazard statements 
Precautionary statements 
Supplemental Hazard Statements 
harmful, irritant
WGK Germany 
3
RTECS 
MD0907700

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