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| Product Code | TC543M |
|---|---|
| CAS | 9005-65-6 |
| Synonym | Tween®80 |
| 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. |
| Product Name | Polysorbate 80 |
|---|---|
| SKU | TC543M |
| CAS No | 9005-65-6 |
| EC No. | 500-019-9 |
| Synonym | Tween® 80 |