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

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

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

Anhydrous 676.83 [620-61-1].
» Hyoscyamine Sulfate contains not less than 98.5 percent and not more than 100.5 percent 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—
B: To about 1 mL of a solution (1 in 20) add gold chloride TS, dropwise with shaking, until a definite precipitate separates. Add a small amount of 3 N hydrochloric 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: A solution (1 in 20) responds to the tests for Sulfate 191.
Melting temperature 741: not less than 200.
Specific rotation 781S: not less than 24.
Test solution: 50 mg per mL, in water.
Loss on drying 731— Dry it in vacuum at 105 for 16 hours: it loses between 2.0% and 5.5% of its weight.
Residue on ignition 281: not more than 0.2%.
Other alkaloids— Dissolve 250 mg in 1 mL of 0.1 N hydrochloric acid, and dilute with water to 15 mL. To 5 mL of the solution add a few drops of platinic chloride TS: no precipitate is formed. To another 5-mL portion add 2 mL of 6 N ammonium hydroxide: the mixture may develop a slight opalescence, but no turbidity or precipitate is formed immediately.
Readily carbonizable substances 271— Dissolve 200 mg in 5 mL of sulfuric acid TS: the solution has no more color than Matching Fluid A.
Organic volatile impurities, Method I 467: meets the requirements.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 1 g of Hyoscyamine Sulfate, accurately weighed, in 50 mL of glacial acetic acid, and titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 67.68 mg of (C17H23NO3)2·H2SO4.
Auxiliary Information— Staff Liaison : Elena Gonikberg, Ph.D., Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29–NF24 Page 1095
Pharmacopeial Forum : Volume No. 31(4) Page 1078
Phone Number : 1-301-816-8251