|
Polysorbate 20 |
|
Synonyms |
Tween® 20 |
|
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. |
|
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% |
|
composition of fatty acids, GC: Resolution (USP) |
>= 1.5, between methyl stearate and methyl oleate |
|
composition of fatty acids, GC: RSD (USP) |
<= 6.0%, peak area responses for the palmitate and stearate peaks |
|
composition of fatty acids, GC: RSD (USP) |
<= 1.0%, peak area response ratio for the palmitate and stearate peaks |
|
composition of fatty acids, GC: Resolution (EP, BP) |
>= 4.0, between the peaks due to methyl caprylate and methyl decanoate |
|
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% |
|
Pack Size |
100ML | 5x100ML |
