Polysorbate 80

SKU:
TC543M
CAS Number : 9005-65-6
Synonym : Tween® 80
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Product Identifier

Product Code TC543M
CAS 9005-65-6
Synonym Tween®80

Technical Specification

Appearance (USP) Lemon to amber coloured, oily liquid
Appearance (EP, BP) Oily, colourless or brownish-yellow, clear or slightly opalescent liquid
Appearance (JP) Colorless or brownish yellow, clear or slightly opalescent, oily liquid.
Appearance (IP) A clear or almost clear, oily, yellowish or brownish yellow liquid
Solubility (USP) Very soluble in water, soluble in alcohol and in ethyl acetate; insoluble in mineral oil
Solubility (IP) Miscible with water, with ethanol, with ethyl acetate and with methanol; practically insoluble in fixed oils and in liquid paraffin
Solubility (EP, ВР) Dispersible in water, in anhydrous ethanol, in ethyl acetate and in methanol, practically insoluble in fatty oils and in liquid paraffin.
Solubility (JP) Miscible with water, with methanol, with ethanol (99.5%) and with ethyl acetate. Practically insoluble in fatty oils and in liquid paraffin
Identification, GC : (JP) Meets the requirements of the composition of fatty acids
Relative density (EP, BP) about 1.10
Identification A : composition of fatty, GC : (USP) Complies
Identification A : FTIR (EP, BP, IP) Matches with the standard pattern
Identification B : FTIR (USP) Matches with the standard pattern
Identification B: Hydroxyl value (EP, BP) 65-80
Identification B (IP) A blue color is produced
Identification C : Saponification value (EP, BP) 45-55
Identification C (IP) Bromine is decolourised
Identification D : Composition of fatty acid, GC (EP, BP) Complies
Identification E (EP, BP) The solution becomes blue
System suitability 1, composition of fatty acids, GC : Resolution (USP, JP) NLT 1.8 between the peaks methyl oleate and methyl stearate
System suitability 2, composition of fatty acids, GC : Theoretical plates (USP, JP) >= 30,000 for the peak of methyl stearate
Composition of fatty acid, GC : Myristic acid (USP, EP, BP, JP) <= 5.00%
Composition of fatty acid, GC : Palmitic acid (USP, EP, BP, JP) <= 16.00%
Composition of fatty acid, GC : Oleic acid (USP, EP, BP, JP) >= 58.00%
Composition of fatty acid, GC : Stearic acid (USP, EP, BP, JP) <= 6.00%
Composition of fatty acid, GC : Palmitoleic acid (USP, EP, BP, JP) <= 8.00%
Composition of fatty acid, GC : Linoleic acid (USP, EP, BP, JP) <= 18.00%
Composition of fatty acid, GC : Linolenic acid (USP, EP, BP, JP) <= 4.00%
Peroxide value (USP, EP, BP, JP) <= 10.00
Hydroxyl value (USP, EP, BP, JP, IP) 65-80
Saponification value (USP, EP, BP, JP, IP) 45-55
Acid value (USP, EP, BP, JP, IP) <=2.00
Iodine value (IP) 18.00 - 24.00
System suitability, Ethylene oxide and dioxane, GC-HS: Resolution (USP, EP, BP, JP) NLT 2.0 between the peaks due to acetaldehyde and ethylene oxide
Ethylene oxide, GC-HS : (USP, EP, BP, JP) <= 0.0001%
Dioxane, GC-HS : (USP, EP, BP, JP) <= 0.0010%
Heavy metals (USP, BP, IP) <= 0.0010%
Heavy metals (JP) <= 0.0020%
Water: (USP, EP, BP, JP, IP) <= 3.00%
Residue on ignition (USP, JP) <= 0.25%
Total ash (EP, ВР) <= 0.25%
Sulphated ash (IP) <= 0.20%
Specific gravity (USP) 1.06 -1.09
Specific gravity, at 20°C : (JP) about 1.10
Viscosity (EP, BP, JP) ~400 mPa.s at 25 °C
Viscosity (USP) 300-500 cSt
Reducing impurities (IP) NMT 5.0 mL of 0.01M ceric ammonium sulphate is required
Storage Condition Store below 30°C away from bright light.
Shelf Life 48 months.
Usage Use before expiry date given on the product lable.
CAS Number : 9005-65-6
Synonym : Tween® 80
More Information
Product Name Polysorbate 80
SKU TC543M
CAS No 9005-65-6
EC No. 500-019-9
Synonym Tween® 80
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