Medium chain Triglycerides MCT Oil

Medium-chain Triglycerides BP Ph Eur Grade:
Medium Chain Triglyceride (MCT Oil)
Caprylic Capric Triglyceride (CCTG)
Glyceryl Tricaprylate/Caprate (GTCC)
Fractionated Coconut Oil

When Medium-chain Triglycerides are prepared from the endosperm of Cocos nucifera L the title fractionated coconut oil may be used.
Action and use: Excipient.

DEFINITION
Mixture of triglycerides of saturated fatty acids, mainly of caprylic (octanoic) acid and of capric (decanoic) acid. The fatty acids are obtained from the oil extracted from the hard, dried fraction of the endosperm of Cocos nucifera L. or from the dried endosperm of Elaeis guineensis Jacq.
Content: Minimum 95.0 per cent of saturated fatty acids with 8 and 10 carbon atoms.

CHARACTERS
Appearance: Colourless or slightly yellowish, oily liquid.
Solubility: Practically insoluble in water, miscible with ethanol (96 per cent), with methylene chloride, with light petroleum and with fatty oils.
Relative density: About 0.95.
Refractive index: About 1.446.

IDENTIFICATION
First identification: C, D
Second identification: A, B, D
A. Iodine value: maximum 1.0.
B. Saponification value: 310 to 360.
C. Composition of fatty acids (see Tests).
D. Viscosity (see Tests).

TESTS
Appearance: The substance to be examined is clear and not more intensely coloured than reference solution.
Alkaline impurities: Dissolve 2.00 g in a mixture of 1.5 mL of ethanol (96 per cent) and 3.0 mL of ether. Add 0.05 mL of bromophenol blue solution. Not more than 0.15 mL of 0.01 M hydrochloric acid is required to change the colour of the indicator to yellow.
Viscosity: 25 mPa⋅s to 33 mPa⋅s.
Acid value: Maximum 0.2.
Hydroxyl value: Maximum 10.
Peroxide value: Maximum 1.0.
Composition of fatty acids: To pass the test.
Composition of the fatty-acid fraction of the substance:
- caproic acid: maximum 2.0 per cent;
- caprylic acid: 50.0 per cent to 80.0 per cent;
- capric acid: 20.0 per cent to 50.0 per cent;
- lauric acid: maximum 3.0 per cent;
- myristic acid: maximum 1.0 per cent;
- fatty acids of chain length greater than or equal to C16: maximum 1.0 per cent.
Atomic absorption spectrometry: To pass the test.
Chromium: Maximum 0.05 ppm, if intended for use in parenteral nutrition.
Copper: Maximum 0.1 ppm, if intended for use in parenteral nutrition.
Lead: Maximum 0.1 ppm, if intended for use in parenteral nutrition.
Nickel: Maximum 0.2 ppm, if intended for use in parenteral nutrition.
Tin: Maximum 0.1 ppm, if intended for use in parenteral nutrition.
Water: Maximum 0.2 per cent, determined on 1.00 g.
Sulfated ash: Maximum 0.1 per cent, determined on 2.0 g.

Medium-Chain Triglycerides USP NF Grade:
Glycerides, mixed decanoyl and octanoyl.
Caprylic and capric triglycerides.

Medium-Chain Triglycerides consist of a mixture of triglycerides of saturated fatty acids, mainly of caprylic acid (C8H16O2) and capric acid (C10H20O2). The fatty acids are derived from the oil extracted from the hard, dried fraction of the endosperm of Cocos nucifera L. or from the dried endosperm of Elaeis guineensis Jacq. They contain not less than 95 percent of saturated fatty acids with 8 and 10 carbon atoms.

Packaging and storage: Preserve in tight containers, protected from light. Store at temperatures not exceeding 25C.
Labeling: Where it is intended for use in parenteral nutrition, it is so labeled.
Appearance: The substance is clear and not more intensely colored than a solution prepared immediately before use by mixing 2.4 mL of ferric chloride and 0.6 mL of cobaltous chloride with Diluent, prepared as directed below, to make 10.0 mL, and diluting 5.0 mL of the solution so obtained with Diluent to make 10.0 mL. Make the comparison by viewing the substance and the solution downward in matched color-comparison tubes against a white surface
Diluent: Transfer 27.5 mL of hydrochloric acid to a 1000-mL volumetric flask, and dilute with water to volume.
Identification:
A: It meets the requirements of the test for Saponification value.
B: It meets the requirements of the test for Fatty acid composition.
Specific gravity: between 0.93 and 0.96, at 20 .
Acid value: not more than 0.2.
Hydroxyl value: not more than 10.
Iodine value: not more than 1.0.
Peroxide value: not more than 1.0.
Saponification value: between 310 and 360, determined on 1.0 g.
Unsaponifiable matter: not more than 0.5%, determined on 5.0 g.
Fatty acid composition: The fatty acid fraction of Medium-Chain Triglycerides exhibits the following composition, as determined in the section Fatty Acid Composition. Disregard any peak with an area less than 0.05% of the total area:
Carbon-Chain Length & Percentage:
6: 2%
8: 50-80%
10: 20-50%
12: 3%
14: 1%
Viscosity: between 25 and 33 centipoises determined at 20 ± 0.1 with a capillary viscosimeter.
Refractive index: between 1.440 and 1.452, at 20.
Alkaline impurities: Dissolve 2.0 g of Medium-Chain Triglycerides in a mixture of 1.5 mL of alcohol and 3.0 mL of ethyl ether. Add 0.05 mL of bromophenol blue, and titrate with 0.01 N hydrochloric acid to a yellow endpoint: not more than 0.15 mL of 0.01 N hydrochloric acid is required.
Water: not more than 0.2%.
Total ash: not more than 0.1%, determined on 2.0 g.
Heavy metals: [NOTE—Use this test for Medium-Chain Triglycerides intended for use other than in parenteral nutrition.]. To pass the test.
Limit of chromium: [NOTE—Use this test for Medium-Chain Triglycerides intended for use in parenteral nutrition.] . To pass the test.
Limit of copper: [NOTE—Use this test for Medium-Chain Triglycerides intended for use other than in parenteral nutrition.]. To pass the test.
Limit of lead: [NOTE—Use this test for Medium-Chain Triglycerides intended for use other than in parenteral nutrition.]. To pass the test.
Limit of nickel: [NOTE—Use this test for Medium-Chain Triglycerides intended for use other than in parenteral nutrition.]. To pass the test.
Limit of tin: [NOTE—Use this test for Medium-Chain Triglycerides intended for use other than in parenteral nutrition.]. 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.