(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].

Packaging and storage— Preserve in tight containers.

USP Reference standards 11— USP Atropine Sulfate RS.

Identification—

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).

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%.

Organic volatile impurities, Method I 467: meets the requirements.

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.

Residual solvents 467: meets the requirements.

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.

Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives

USP29–NF24 Page 219

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