Glycerol Monooleate

Glycerol Mono-oleate BP Ph Eur Grade Specifications
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.

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.

Glyceryl Monooleate USP Grade Specifications
Oleic acid, 2,3-dihydroxypropyl ester, (±).
(RS)-1-Glyceryl oleate --- 356.54 --- CAS 25496-72-4

Glyceryl Monooleate is a mixture of monoglycerides, mainly glyceryl monooleate, together with variable quantities of diglycerides and triglycerides. It is obtained by partial glycerolysis of vegetable oil that consists mainly of triglycerides of oleic acid, or by esterification of glycerol with oleic acid of vegetable or animal origin. It is defined by the nominal content of monoglycerides, and the assay requirements differ as set forth in the accompanying table. A suitable antioxidant may be added.

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.

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.

Assay
To pass the test.

Certifications :
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP/BP/USP/NF/Ph. Eur, JP/ CP), Speciality Chemicals(Pure/AR/ACS), Mineral Fortifiers, Food Chemical Codex (FCC) and Flavour chemicals. Our manufacturing facility is cGMP, GLP, ISO 9001, ISO 14001, ISO 22000, ISO/IEC 17025, FSSC 22000, FSSAI, Kosher, HALAL, EXCiPACT, WC, COPP, WHO-GMP and WC certified. We are also REACH registered for export to European countries.