U.S. PHARMACOPEIA

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Paraffin
» Paraffin is a purified mixture of solid hydrocarbons obtained from petroleum.
Packaging and storage— Preserve in well-closed containers, and avoid exposure to excessive heat.
Identification—
A: When strongly heated, it ignites with a luminous flame and deposits carbon.
B: Heat about 500 mg in a dry test tube with an equal weight of sulfur: the mixture evolves hydrogen sulfide and becomes black as a result of the liberation of carbon.
Congealing range 651: between 47 and 65.
Reaction— Shake melted Paraffin with an equal volume of hot alcohol previously neutralized to litmus: the separated alcohol is neutral to litmus.
Readily carbonizable substances 271 Use a clean, dry, heat-resistant, glass-stoppered test tube, 140 ± 3 mm in length and 14 ± 1 mm in diameter, with a capacity of 16 ± 1 mL when the stopper is inserted, and calibrated at the 5- and 10-mL liquid levels. Place in the test tube 5 mL of Paraffin, at a temperature just above the melting point, add 5 mL of sulfuric acid containing 94.5% to 94.9% of H2SO4, and heat in a water bath at 70 for 10 minutes. When 5 minutes have elapsed, and at each successive minute thereafter, remove the tube from the bath, place a finger over the stopper, and give the tube three vigorous vertical shakes over an amplitude of about 12 cm, returning the tube to the bath within 3 seconds after the time when it was removed therefrom. At the end of 10 minutes from the time the tube was placed in the bath, the acid has no more color than a mixture of 3 mL of ferric chloride CS, 1.5 mL of cobaltous chloride CS, and 0.50 mL of cupric sulfate CS, overlaid with 5 mL of mineral oil. If the sulfuric acid remains dispersed in the molten paraffin, the color of the emulsion is not darker than that of the standard mixture when shaken vigorously.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Auxiliary Information— Staff Liaison : Hong Wang, Ph.D. , Senior Scientific Associate
Expert Committee : (EM205) Excipient Monographs 2
USP29–NF24 Page 3386
Pharmacopeial Forum : Volume No. 31(5) Page 1426
Phone Number : 1-301-816-8351