Atropine Sulfate
(C17H23NO3)2·H2SO4·H2O 694.83

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

1H,5H-Tropan-3--ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate [5908-99-6].

Anhydrous 676.83 [55-48-1].
» Atropine Sulfate contains not less than 98.5 percent and not more than 101.0 percent of (C17H23NO3)2·H2SO4, calculated on the anhydrous basis.
[Caution—Handle Atropine Sulfate with exceptional care, since it is highly potent. ]
Packaging and storage— Preserve in tight containers.
B: A solution (1 in 20) meets the requirements of the tests for Sulfate 191.
Melting temperature, Class Ia 741: not lower than 187, determined after drying at 120 for 4 hours. [note—Since anhydrous Atropine Sulfate is hygroscopic, determine its melting temperature promptly on a specimen placed in the capillary tube immediately after drying.]
Angular rotation 781A The observed rotation, in degrees, multiplied by 200, and divided by the length, in mm, of the polarimeter tube used, is between 0.60 and +0.05 (limit of hyoscyamine).
Test solution— Dissolve 1 g, accurately weighed, in water to make a volume of 20 mL at 25.
Acidity— Dissolve 1.0 g in 20 mL of water, add 1 drop of methyl red TS, and titrate with 0.020 N sodium hydroxide: not more than 0.30 mL is required to produce a yellow color.
Water, Method I 921: not more than 4.0%.
Residue on ignition 281: not more than 0.2%.
Other alkaloids— Dissolve 150 mg in 10 mL of water. To 5 mL of the solution add a few drops of platinic chloride TS: no precipitate is formed. To the remaining 5 mL of the solution add 2 mL of 6 N ammonium hydroxide, and shake vigorously: a slight opalescence may develop but no turbidity is produced.
Assay— Dissolve about 1 g of Atropine 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 (C17H23 NO3)2·H2SO4.
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Monograph Ravi Ravichandran, Ph.D.
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(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 1604
Pharmacopeial Forum: Volume No. 29(6) Page 1847
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.