Polysorbate 20

SKU:
TC287M
CAS Number : 9005-64-5
Synonym : Tween®20
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Product Identifier

CAS No. 9005-64-5
Synonym Tween® 20

Technical Specification

Appearance (USP) Lemon to amber coloured liquid
Appearance (EP, BP) Oily, yellow or brownish-yellow, clear or slightly opalescent liquid
Appearance (IP) A clear or slightly opalescent, oily, yellowish or brownish yellow liquid
Solubility (USP) Soluble in water, in alcohol, in ethyl acetate; in methanol and in dioxane; insoluble in mineral oil
Solubility (EP, BP) Soluble in water, in anhydrous ethanol, in ethyl acetate and in methanol. Practically insoluble in fatty oils and in liquid paraffin.
Solubility (IP) Miscible with water, with ethanol, with ethyl acetate and with methanol; practically insoluble in fixed oils and in liquid paraffin
pH (5% in water) : (IP) 5.0 - 7.0
Identification A : FTIR (USP, EP, BP, IP) Matches with the standard pattern
Identification B : Hydroxyl value (EP, BP) 96.0 - 108.0
Identification B: (IP) A blue colour is produced
Identification B: Composition of fatty acid, GC (USP) Meets the requirements
Identification C : Saponification value (EP, BP) 40.0 - 50.0
Identification D: Composition of fatty acids, GC (EP, BP) Complies
Identification Test E (EP, BP) The solution becomes blue
Acid value (USP, EP, BP, IP) <= 2.0
Hydroxyl value (USP, EP, BP, IP) 96 - 108
Peroxide value (USP, EP, BP) <= 10.0
Iodine value (IP) <= 5.0
Saponification value (USP, EP, BP, IP) 40.0 - 50.0
Relative density (EP, BP) about 1.10
Reducing impurities : (IP) NMT 2.0 mL of 0.01M ceric ammonium sulphate is required
viscosity (EP, BP) ~400 mPa.s at 25°C
Heavy metals (IP) <= 0.0010%
System suitability, limit of ethylene oxide : Resolution (USP) >= 2.0
Limit of ethylene oxide, GC-HS (USP, EP, BP) <= 0.0001%
Limit of Dioxane, GC-HS (USP, EP, BP) <= 0.0010%
Residue on ignition (USP) <= 0.25%
Total ash (EP, BP) <= 0.25%
Sulphted ash (IP) <= 0.2%
Water (USP, EP, BP, IP) <= 3.0%
System suitability 1, composition of fatty acids, GC: Resolution (USP) >= 1.5, between methyl stearate and methyl oleate
System suitability 2, composition of fatty acids, GC: RSD (USP) <= 6.0%, peak area responses for the palmitate and stearate peaks
System suitability 3, composition of fatty acids, GC: RSD (USP) <= 1.0%, peak area response ratio for the palmitate and stearate peaks
System suitability 4, composition of fatty acids, GC: Resolution (EP, BP) >= 4.0, between the peaks due to methyl caprylate and methyl decanoate
System suitability 5, composition of fatty acids, GC: Theoretical plates (EP, BP) >= 15,000 for the peak due to methyl decanoate
Composition of fatty acids 1, GC : Caproic acid (USP, EP, BP) <= 1.0%
Composition of fatty acids 2, GC : Caprylic acid (USP, EP, BP) <= 10.0%
Composition of fatty acids 3, GC : Capric acid (USP, EP, BP) <= 10.0%
Composition of fatty acids 4, GC : lauric acid (USP, EP, BP) 40.0 - 60.0%
Composition of fatty acids 5, GC : myristic acid (USP, EP, BP) 14.0 - 25.0%
Composition of fatty acids 6, GC : palmitic acid (USP, EP, BP) 7.0 - 15.0%
Composition of fatty acids 7, GC : stearic acid (USP) <= 11.0%
Composition of fatty acids 8, GC : stearic acid (EP, BP) <= 7.0%
Composition of fatty acids 9, GC : oleic acid (USP, EP, BP) <= 11.0%
Composition of fatty acids 10, GC : linoleic acid (USP, EP, BP) <= 3.0%

Storage and Shelf Life

Storage Store below 30°C away from bright light.
Shelf life 48 months. Use before expiry date given on the product label.
CAS Number : 9005-64-5
Synonym : Tween®20
More Information
Product Name Polysorbate 20
SKU TC287M
CAS No 9005-64-5
EC No. 500-018-3
Synonym Tween®20
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