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Medium-Chain Triglycerides
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 25
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 CS and 0.6 mL of cobaltous chloride CS 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 (see Color and Achromicity
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
Acid value
Hydroxyl value
Iodine value
Peroxide value
Saponification value
Unsaponifiable matter
Fatty acid composition
Viscosity
Refractive index
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 TS, 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, Method I
Total ash
Heavy metals, Method II
Test solution
Transfer 2.0 g of Medium-Chain Triglycerides to a quartz crucible, add 0.5 g of magnesium oxide, and mix. Ignite the crucible to dull redness until a homogeneous white or grayish-white mass is obtained. Ignite at 800
Standard solution
To 0.5 g of magnesium oxide add 2.0 mL of Standard Lead Solution, and evaporate to dryness at 105
Procedure
To 12 mL of the Test solution, add 2.0 mL of pH 3.5 Acetate Buffer, mix, add to 1.2 mL of thioacetamide-glycerin base TS, and mix immediately. To 10 mL of the Standard solution, add 2.0 mL of the Test solution, add 2.0 mL of pH 3.5 Acetate Buffer, mix, add to 1.2 mL of thioacetamide-glycerin base TS, and mix immediately. Prepare a blank, using a mixture of 10 mL of water and 2.0 mL of the Test solution. Compared to the blank, the Standard solution shows a light brown color. Dilute both the Test solution and the Standard solution with water to 50 mL, allow to stand for 2 minutes, and view downward over a white surface: any brown color from the Test solution is not darker than that of the solution from the Standard solution (not more than 10 µg per g).
Limit of chromium
[noteUse this test for Medium-Chain Triglycerides intended for use in parenteral nutrition.]
Test stock solution
Transfer about 50 g of Medium-Chain Triglycerides to a 100-mL volumetric flask, dissolve in and dilute with diisobutyl ketone to volume.
Test solution
Transfer 4.0 mL of Test stock solution to a 10-mL volumetric flask, and dilute with diisobutyl ketone to volume.
Chromium standard solution
Transfer about 0.283 g of potassium dichromate, previously dried at 105
Standard solutions
Into each of three 10-mL volumetric flasks, transfer 4.0 mL of Test stock solution, add 0.5, 1.0, and 2.0 mL, respectively, of Chromium standard solution, and dilute with diisobutyl ketone to volume. These solutions contain 0.005 µg, 0.01 µg, and 0.02 µg of chromium per mL, respectively.
Procedure
Concomitantly determine the absorbances of the Standard solutions and the Test solution at least three times each, at the wavelength of maximum absorbance at 357.8 nm, with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-Scattering
Limit of copper
[noteUse this test for Medium-Chain Triglycerides intended for use in parenteral nutrition.]
Test stock solution and Test solution
Proceed as directed in the test for Limit of chromium.
Copper standard solution
Transfer about 0.393 g of cupric sulfate, accurately weighed, to a 1000-mL volumetric flask, and dilute with water to volume. Immediately before use, dilute this solution with water to 1000 times its volume. This solution contains the equivalent of 0.1 µg of copper per mL.
Standard solutions
Into each of three 10-mL volumetric flasks, transfer 4.0 mL of Test stock solution, add 1.0, 2.0, and 4.0 mL, respectively, of Copper standard solution, and dilute with diisobutyl ketone to volume. These solutions contain 0.01 µg, 0.02 µg, and 0.04 µg of copper per mL, respectively.
Procedure
Concomitantly determine the absorbances of the Standard solutions and the Test solution at least three times each, at the wavelength of maximum absorbance at 324.7 nm, with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-Scattering
Limit of lead
[noteUse this test for Medium-Chain Triglycerides intended for use in parenteral nutrition.]
Test stock solution and Test solution
Proceed as directed in the test for Limit of chromium.
Lead standard solution
Dissolve 160 mg of lead nitrate in 100 mL of water that contains 1 mL of lead-free nitric acid, and dilute with water to 1000 mL. Pipet 10 mL of this solution into a 100-mL volumetric flask, dilute with water to volume, and mix. Immediately before use, dilute this solution with water to 100 times its volume. This solution contains the equivalent of 0.1 µg of lead per mL.
Standard solutions
Into each of three 10-mL volumetric flasks, transfer 4.0 mL of Test stock solution, add 1.0, 2.0, and 4.0 mL, respectively, of Lead standard solution, and dilute with diisobutyl ketone to volume. These solutions contain 0.01 µg, 0.02 µg, and 0.04 µg of lead per mL, respectively.
Procedure
Concomitantly determine the absorbances of the Standard solutions and the Test solution at least three times each, at the wavelength of maximum absorbance at 283.3 nm, with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-Scattering
Limit of nickel
[noteUse this test for Medium-Chain Triglycerides intended for use in parenteral nutrition.]
Test stock solution and Test solution
Proceed as directed in the test for Limit of chromium.
Nickel standard solution
Immediately before use, dilute 10 mL of nickel standard solution TS with water to 1000 mL. This solution contains the equivalent of 0.1 µg of nickel per g.
Standard solutions
Into each of three 10-mL volumetric flasks, transfer 4.0 mL of Test stock solution, add 1.0, 2.0, and 4.0 mL, respectively, of Nickel standard solution, and dilute with diisobutyl ketone to volume. These solutions contain 0.01 µg, 0.02 µg, and 0.04 µg of nickel per mL, respectively.
Procedure
Concomitantly determine the absorbances of the Standard solutions and the Test solution at least three times each, at the wavelength of maximum absorbance at 232 nm, with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-Scattering
Limit of tin
[noteUse this test for Medium-Chain Triglycerides intended for use in parenteral nutrition.]
Test stock solution and Test solution
Proceed as directed in the test for Limit of chromium.
Tin standard solution
Dissolve 500 mg of metallic tin (Sn), accurately weighed, in a mixture of 5 mL of water and 25 mL of hydrochloric acid, and dilute with water to 1000 mL. Immediately before use, dilute 10 mL of this solution with dilute hydrochloric acid (2.5 in 100) to 1000 mL, and then dilute 10 mL of the solution so obtained with water to 500 mL. This solution contains the equivalent of 0.1 µg of tin per g.
Standard solutions
Into each of three 10-mL volumetric flasks, transfer 4.0 mL of Test stock solution, add 1.0, 2.0, and 4.0 mL, respectively, of Tin standard solution, and dilute with diisobutyl ketone to volume. These solutions contain 0.01 µg, 0.02 µg, and 0.04 µg of tin per mL, respectively.
Procedure
Concomitantly determine the absorbances of the Standard solutions and the Test solution at least three times each, at the wavelength of maximum absorbance at 286.3 nm, with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-Scattering
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 1372
Pharmacopeial Forum: Volume No. 31(1) Page 98
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