Hyoscyamine Sulfate
(C17H23NO3)2·H2SO4·2H2O 712.85

Benzeneacetic acid,a-(hydroxymethyl)-,8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester,[3(S)-endo]-,sulfate (2:1),dihydrate.

1aH,5aH-Tropan-3a-ol (-)-tropate (ester)sulfate (2:1)(salt)dihydrate [6835-16-1].

Anhydrous 676.83 [620-61-1].
»Hyoscyamine Sulfate contains not less than 98.5percent and not more than 100.5percent of (C17H23NO3)2·H2SO4,calculated on the dried basis.[Caution—Handle Hyoscyamine Sulfate with exceptional care,since it is highly potent. ]
Packaging and storage— Preserve in tight,light-resistant containers.
Identification—
A: Infrared Absorption á197Kñ.
B: To about 1mLof a solution (1in 20)add gold chloride TS,dropwise with shaking,until a definite precipitate separates.Add a small amount of 3Nhydrochloric acid,dissolve the precipitate with the aid of heat,and allow the solution to cool:lustrous golden yellow scales are formed (distinction from atropine and scopolamine).
C: Asolution (1in 20)responds to the tests forSulfate á191ñ.
Melting temperature á741ñ: not less than 200.
Specific rotation á781Sñ: not less than -24.
Test solution: 50mg per mL,in water.
Loss on drying á731ñ— Dry it in vacuum at 105for 16hours:it loses between 2.0%and 5.5%of its weight.
Residue on ignition á281ñ: not more than 0.2%.
Other alkaloids— Dissolve 250mg in 1mLof 0.1Nhydrochloric acid,and dilute with water to 15mL.To 5mLof the solution add a few drops of platinic chloride TS:no precipitate is formed.To another 5-mLportion add 2mLof 6Nammonium hydroxide:the mixture may develop a slight opalescence,but no turbidity or precipitate is formed immediately.
Readily carbonizable substances á271ñ— Dissolve 200mg in 5mLof sulfuric acid TS:the solution has no more color than Matching Fluid A.
Organic volatile impurities,Method Iá467ñ: meets the requirements.
Assay— Dissolve about 1g of Hyoscyamine Sulfate,accurately weighed,in 50mLof glacial acetic acid,and titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 67.68mg of (C17H23NO3)2·H2SO4.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 986
Pharmacopeial Forum:Volume No.29(5)Page 1507
Phone Number:1-301-816-8251