C30H62 422.81

Tetracosane, 2,6,10,15,19,23-hexamethyl-.
2,6,10,15,19,23-Hexamethyltetracosane [111-01-3].

Packaging and storage— Preserve in tight containers.

USP Reference standards 11— USP Squalane RS.

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.

Residual solvents 467: meets the requirements.

Expert Committee : (EM105) Excipient Monographs 1

USP29–NF24 Page 3435

Phone Number : 1-301-816-8262