Fully Hydrogenated Rapeseed Oil
Fully hydrogenated rapeseed oil
[84681-71-0].» Fully Hydrogenated Rapeseed Oil is the product obtained by refining and hydrogenating oil obtained from the seeds of Brassica napus and Brassica campestris (Fam. Cruciferae). The product is a mixture of triglycerides in which the fatty acid composition is a mixture of saturated fatty acids.
Packaging and storage—
Preserve in tight, light-resistant containers. No storage requirements specified.
Identification—
It meets the requirements of the test for Fatty acid composition.
Acid value 
401
:
not more than 6.0.
401:
not more than 6.0.
Iodine value 401:
not more than 4.
401:
not more than 4.
Peroxide value 401:
not more than 2.0.
401:
not more than 2.0.
Unsaponifiable matter 401:
not more than 1.5%.
401:
not more than 1.5%.
Fatty acid composition—
Fully Hydrogenated Rapeseed Oil exhibits the following fatty acid composition profile, as determined in the section Fatty Acid Composition under Fats and Fixed Oils 401:
401:
| Carbon-Chain Length | Number of Double Bonds |
Percentage (%) |
| 14 | 0 | <1.0 |
| 16 | 0 | 3–5 |
| 18 | 0 | 38–42 |
| 20 | 0 | 8–10 |
| 22 | 0 | 42–50 |
| 24 | 0 | 1.0–2.0 |
| 18 | 1 |  1.0 |
| 18 | 2 | <1.0 |
| 20 | 1 | <1.0 |
| 22* | 1 | 1.0 |
|
*
Erucic acid.
|
||
Residue on ignition 281:
when a 5-g sample of Fully Hydrogenated Rapeseed Oil is ignited at an ignition temperature of 800 ± 25
, not more than 0.5%.
281:
when a 5-g sample of Fully Hydrogenated Rapeseed Oil is ignited at an ignition temperature of 800 ± 25, not more than 0.5%.
Heavy metals, Method II 231:
0.001%.
231:
0.001%.
Limit of erucic acid:
not more than 1.0%, as determined in the test for Fatty acid composition.
Alkaline impurities—
Prepare a mixture of 2.0 g of Fully Hydrogenated Rapeseed Oil, 1.5 mL of alcohol, and 3.0 mL of toluene. Dissolve by gentle heating. Add 0.05 mL of bromophenol blue TS, and titrate with 0.01 N hydrochloric acid to a yellow endpoint: not more than 0.4 mL of 0.01 N hydrochloric acid is required.
Limit of nickel—
Test solution—
Weigh 5.0 g of Fully Hydrogenated Rapeseed Oil into a previously tared platinum or silica crucible. Cautiously heat the substance, and introduce into it a wick formed from twisted ashless filter paper. Ignite the wick. When the substance ignites, stop heating. After combustion, ignite in a muffle furnace at about 600. Continue the incineration until white ash is obtained. After cooling, transfer the residue, with the aid of two 2-mL portions of diluted hydrochloric acid, to a 25-mL volumetric flask, add 0.3 mL of nitric acid, and dilute with water to volume.
. Continue the incineration until white ash is obtained. After cooling, transfer the residue, with the aid of two 2-mL portions of diluted hydrochloric acid, to a 25-mL volumetric flask, add 0.3 mL of nitric acid, and dilute with water to volume.
Nickel standard solution—
Immediately before use, dilute 10 mL of nickel standard solution TS with water to 500 mL. This solution contains the equivalent of 0.2 µg of nickel per mL.
Standard solutions—
Into three identical 10-mL volumetric flasks, introduce respectively 1.0, 2.0, and 4.0 mL of Nickel standard solution. To each flask, add a 2.0-mL portion of the Test solution, and dilute with water to volume.
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 232.0 nm, with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-Scattering 851) equipped with a graphite furnace and a nickel hollow-cathode lamp. Record the average of the steady readings for each of the Standard solutions and the Test solution. Plot the absorbances of the Standard solutions and the Test solution versus the added quantity of nickel. [note—The Test solution should be plotted as if it had a content of added nickel equivalent to 0 µg.] Extrapolate the line joining the points on the graph until it meets the concentration axis. The distance between this point and the intersection of the axes represents the concentration of nickel, C, in µg per mL, in the Test solution. Calculate the content of nickel in the portion of Fully Hydrogenated Rapeseed Oil taken by the formula:
851) equipped with a graphite furnace and a nickel hollow-cathode lamp. Record the average of the steady readings for each of the Standard solutions and the Test solution. Plot the absorbances of the Standard solutions and the Test solution versus the added quantity of nickel. [note—The Test solution should be plotted as if it had a content of added nickel equivalent to 0 µg.] Extrapolate the line joining the points on the graph until it meets the concentration axis. The distance between this point and the intersection of the axes represents the concentration of nickel, C, in µg per mL, in the Test solution. Calculate the content of nickel in the portion of Fully Hydrogenated Rapeseed Oil taken by the formula:
25C / W
in which W is the weight, in g, of Fully Hydrogenated Rapeseed Oil taken to prepare the Test solution: not more than 1 µg per g is found.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Hong Wang, Ph.D.
Scientist 1-301-816-8351 |
(EM205) Excipient Monographs 2 |
USP32–NF27 Page 1331
Pharmacopeial Forum: Volume No. 32(6) Page 1771