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