Tween® 80 (Polysorbate), EMPROVE® ESSENTIAL Ph. Eur., JP, NF, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS

8.17061.1000 8.17061.2500 8.17061.9050 8.17061.9025 8.17061.9010
8.17061.1000EA 301 EUR
8.17061.1000 8.17061.2500 8.17061.9050 8.17061.9025 8.17061.9010
Tween® 80 (Polysorbate), EMPROVE® ESSENTIAL Ph. Eur., JP, NF, SAFC®
Tween® 80 (Polysorbate)
Boiling Pt: ∼100 °C (1013 hPa)
Melting Pt: –21 °C
Density: 1,062 g/cm³ (20 °C)
Flash Pt: >149 °C
Storage Temperature: Ambient
MDL Number: MFCD00082107
CAS Number: 9005-65-6
EINECS: 500-019-9
Merck Index: 13,07664

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Specification Test Results

Appearance Oily, Yellowish or Brownish-Yellow, Clear Liquid
pH-Value (25 °C) 5.5 - 7.5
Identity (IR Spectroscopy) Conforms
Identity (According to NF) Conforms
Identity (According to JP) Conforms
Identity (According to Ph.Eur.) Conforms
Density (d 20/20) 1.065 - 1.095
Density (d 25/25) 1.06 - 1.09
Viscosity (25 °C) 345 - 445 mm²/s
Viscosity (25 °C) 300 - 500 mPas
Acid Value ≤2.0
Hydroxyl Value 65 - 80
Peroxide Value ≤10.0
Saponification Value 45 - 55
Iodine Number 19 - 24
Formaldehyde ≤15 ppm
Fraction (Myristic Acid) ≤5.0%
Fraction (Palmitic Acid) ≤16.0%
Fraction (Palmitoleic acid) ≤8.0%
Fraction (Stearic Acid) ≤6.0%
Fraction (Oleic Acid) 58.0 - 85.0%
Fraction (Linoleic Acid) ≤18.0%
Fraction (Linolenic Acid) ≤4.0%
Ethylene Oxide ≤1 ppm
1,4 Dioxane ≤10 ppm
Ethylene Glycol (ace. to ICH-guideline class 2) ≤620 ppm
Heavy Metals ≤10 ppm
Arsenic ≤2 ppm
Water (K.F.) ≤3.0%
Sulfated Ash ≤0.10%
Total Ash ≤0.25%
Other residual solvents acc. to ICH-guideline are excluded by the manufacturing process
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 Ph. Eur., NF and JP.

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