We manufacture and supply Oleic acid, Sodium Oleate, Potassium Oleate, Ethyl Oleate, Glycerol Monooleate etc.
Action and use: Excipient.
Ph Eur
DEFINITION
Mixture of monoacylglycerols, mainly mono-oleoylglycerol, together with variable quantities of di- and triacylglycerols. It is defined by the nominal content of monoacylglycerols and obtained by partial glycerolysis of vegetable oils mainly containing triacylglycerols of oleic (cis-9-octadecenoic) acid or by esterification of glycerol by oleic acid, this fatty acid being of vegetable or animal origin. A suitable antioxidant may be added.
Content:
Nominal content of acylglycerol (percent) | |||
40 | 60 | 90 | |
Monoaclylglycerol | 32-52 | 55-65 | 90-100 |
Diaclylglycerol | 30-50 | 15-35 | <10 |
Triaclylglycerol | 5-20 | 2-10 | <2 |
CHARACTERS
Appearance: Amber, oily liquid which may be partially solidified at room temperature.
Solubility: Practically insoluble in water, freely soluble in methylene chloride.
IDENTIFICATION
A. Iodine value (see Tests).
B. Thin-layer chromatography to pass the test.
C. It complies with the limits of the assay (monoacylglycerol content).
TESTS
Acid value: Maximum 6.0, determined on 1.0 g.
Iodine value: 65.0 to 95.0.
Peroxide value: Maximum 12.0, determined on 2.0 g.
Saponification value: 150 to 175, determined on 2.0 g.
Free glycerol: Maximum 6.0 per cent, determined as described in the assay.
Composition of fatty acids:
Composition of the fatty acid fraction of the substance
palmitic acid : maximum 12.0 per cent.
stearic acid : maximum 6.0 per cent.
oleic acid : minimum 60.0 per cent.
linoleic acid : maximum 35.0 per cent.
linolenic acid : maximum 2.0 per cent.
arachidic acid: maximum 2.0 per cent.
eicosenoic acid: maximum 2.0 per cent.
Water: Maximum 1.0 per cent, determined on 1.00 g. Use as the solvent a mixture of equal volumes of anhydrous methanol and methylene chloride R.
Total ash: Maximum 0.1 per cent.
ASSAY
To pass the test.
STORAGE
In an airtight container, protected from light.
Nominal Content of Monoglycerides (%) | |||
40 | 60 | 90 | |
Monoglycerides | 32-52 | 55-65 | 90-101 |
Diglycerides | 30-50 | 15-35 | <10 |
Triglycerides | 5-20 | 2-10 | <2 |
Packaging and storage: Preserve in tight containers. No storage requirements specified.
Labeling: The labeling indicates the nominal content of monoglycerides and the name and the concentration of any added antioxidant.
Identification:
A: Thin-Layer Chromatographic Identification to pass the test
B: It meets the requirements of the test for Iodine value.
Acid value: not more than 6.0, determined on 1.0 g.
Iodine value: between 65.0 and 95.0.
Peroxide value: not more than 12.0, determined on 2.0 g.
Saponification value: between 150 and 175 determined on 2.0 g.
Fatty acid composition: Glyceryl Monooleate exhibits the following composition profile of fatty acids.
Carbon-Chain Length | No. of Double Bonds | Percentage (%) |
16 | 0 | not more than 12.0 |
18 | 0 | not more than 6.0 |
18 | 1 | not less than 60.0 |
18 | 2 | not more than 35.0 |
18 | 3 | not more than 2.0 |
20 | 0 | not more than 2.0 |
20 | 1 | not more than 2.0 |
Water: not more than 1.0%, using a mixture of methanol and methylene chloride (1:1, v/v) in place of methanol in the titration vessel.
Total ash: not more than 0.1%.
Limit of free glycerin: not more than 6.0% of free glycerin is found.