Methohexital
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C14H18N2O3 262.30

2,4,6(1H,3H,5H)-Pyrimidinetrione,1-methyl-5-(1-methyl-2-pentynyl)-5-(2-propenyl)-,(±)-.
(±)-5-Allyl-1-methyl-5-(1-methyl-2-pentynyl)barbituric acid [18652-93-2].
»Methohexital contains not less than 98.0percent and not more than 101.0percent of C14H18N2O3,calculated on the anhydrous basis.
Packaging and storage— Preserve in well-closed containers.
Identification,Infrared Absorptioná197Sñ
Solution: 1in 100.
Medium: chloroform.
Melting range á741ñ: between 92and 96,but the range between beginning and end of melting does not exceed 3.
Water,Method Iá921ñ: not more than 2.0%.
Chloride á221ñ Dissolve 200mg in a mixture of 75mLof ether and 25mLof water,agitate,and allow to separate:the water solution shows no more chloride than corresponds to 0.17mLof 0.010Nhydrochloric acid (0.03%).
Ordinary impurities á466ñ
Test solution: methanol.
Standard solution: methanol.
Eluant: a mixture of chloroform and acetone (7:3).
Visualization— Expose the plate to chlorine gas for 1minute,and air-dry the plate at room temperature for 2minutes.Prepare a solution of 0.5g of potassium iodide in 50mLof water,and prepare a solution of 1.5g of soluble starch in 50mLof hot water.Mix 10mLof each solution with 4mLof alcohol to obtain the Detection reagent.[NOTE—The Detection reagent so obtained may be used for up to 3or 4days.]Spray the plate with the Detection reagent.
Assay— Dissolve about 100mg of Methohexital,accurately weighed,in chloroform,and dilute quantitatively and stepwise with chloroform to obtain a solution having a concentration of about 10mg per mL.Dissolve an accurately weighed quantity of USP Methohexital RSin chloroform,and dilute quantitatively and stepwise with chloroform to obtain a Standard solution having a known concentration of about 10mg per mL.Concomitantly determine the absorbances of both solutions in 0.1-mm cells at the wavelength of maximum absorbance at about 5.93µm,with a suitable spectrophotometer,using chloroform as the blank.Calculate the quantity,in mg,of C14H18N2O3in the portion of Methohexital taken by the formula:
10C(AU/AS),
in which Cis the concentration,in mg per mL,of USP Methohexital RSin the Standard solution;and AUand ASare the absorbances of the solution of Methohexital and the Standard solution,respectively.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1247
Pharmacopeial Forum:Volume No.29(5)Page 1534
Phone Number:1-301-816-8379