» Squalane is a saturated hydrocarbon obtained by hydrogenation of squalene, an aliphatic triterpene occurring in some fish oils.
Packaging and storage Preserve in tight containers.
USP Reference standards 11
Identification, Infrared Absorption 197F, on undried specimen.
Specific gravity 841: between 0.807 and 0.810 at 20.
Acid value 401: not more than 0.2.
Iodine value 401: not more than 4.
Saponification value 401: not more than 2.
Refractive index 831: between 1.4510 and 1.4525 at 20.
Residue on ignition 281: not more than 0.5%.
Chromatographic purity Inject about 2 µL of a 2 in 100 solution of Squalane in n-hexane into a suitable gas chromatograph, equipped with a flame-ionization detector. Under typical conditions the instrument contains a 3-mm × 1.8-m column packed with 3% phase G1 on packing S1A, the column is temperature-programmed at about 6 per minute from 130 to 270, the injection port and the detector block are maintained at 280, and nitrogen is used as the carrier gas at a flow rate of 25 mL per minute. Identify the squalane peak by comparison of the retention time with that of the main peak obtained by chromatographing a similar solution of USP Squalane RS under the same conditions: the area of the squalane peak is not less than 97% of the sum of the areas of all of the peaks in the chromatogram.
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USP35NF30 Page 1970