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Thiopental Sodium
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C11H17N2NaO2S 264.32

4,6(1H,5H)-Pyrimidinedione, 5-ethyldihydro-5-(1-methylbutyl)-2-thioxo-, monosodium salt, (±)-.
Sodium (±)-5-ethyl-5-(1-methylbutyl)-2-thiobarbiturate [71-73-8].
» Thiopental Sodium contains not less than 97.0 percent and not more than 102.0 percent of C11H17N2NaO2S, calculated on the dried basis.
Packaging and storage— Preserve in tight containers.
A: Dissolve about 500 mg in 10 mL of water in a separator, add 10 mL of 3 N hydrochloric acid, and extract the liberated thiopental with two 25-mL portions of chloroform. Evaporate the combined chloroform extracts to dryness. Add 10 mL of ether, evaporate again, and dry at 105 for 2 hours: the IR absorption spectrum of a potassium bromide dispersion of the residue so obtained exhibits maxima only at the same wavelengths as that of a similar preparation of USP Thiopental RS.
B: Ignite about 500 mg: the residue responds to the tests for Sodium 191.
C: Dissolve about 200 mg in 5 mL of 1 N sodium hydroxide, and add 2 mL of lead acetate TS: a white precipitate is formed, and it gradually darkens when the mixture is boiled. Acidify the darkened mixture with hydrochloric acid: hydrogen sulfide is evolved, and it is recognizable by its darkening of moistened lead acetate test paper held in the vapor.
Loss on drying 731 Dry it at 80 for 4 hours: it loses not more than 2.0% of its weight.
Heavy metals, Method II 231: 0.002%.
Ordinary impurities 466
Test solution: 10 mg of Thiopental Sodium per mL of methanol.
Standard solution: 9.2 mg of USP Thiopental RS per mL of methanol.
Application volume: 40 µL.
Eluant: a mixture of toluene and methanol (85:15).
Visualization: 1.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Transfer about 100 mg of Thiopental Sodium, accurately weighed, to a 200-mL volumetric flask, add sodium hydroxide solution (1 in 250) to volume, and mix. Pipet 5 mL of the solution into a 500-mL volumetric flask, add sodium hydroxide solution (1 in 250) to volume, and mix. Dissolve an accurately weighed quantity of USP Thiopental RS in sodium hydroxide solution (1 in 250), and dilute quantitatively and stepwise with sodium hydroxide solution (1 in 250) to obtain a Standard solution having a known concentration of about 5 µg per mL. Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 304 nm, with a suitable spectrophotometer, using sodium hydroxide solution (1 in 250) as the blank. Calculate the quantity, in mg, of C11H17N2NaO2S in the Thiopental Sodium taken by the formula:
20C(1.091AU / AS),
in which C is the concentration, in µg per mL, of USP Thiopental RS in the Standard solution, 1.091 is the ratio of the molecular weight of thiopental sodium to that of thiopental, and AU and AS are the absorbances of the solution of Thiopental Sodium and the Standard solution, respectively.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 2130
Pharmacopeial Forum : Volume No. 29(5) Page 1586
Phone Number : 1-301-816-8143