(C17H23NO3)2·H2SO4·H2O 694.83

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

1aH,5aH-Tropan-3-a-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 á11ñ— USP Atropine Sulfate RS.

Identification—

Melting temperature,Class Ia á741ñ: not lower than 187,determined after drying at 120for 4hours.[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 á781Añ— The observed rotation,in degrees,multiplied by 200,and divided by the length,in mm,of the polarimeter tube used,is between -0.60and +0.05(limit of hyoscyamine).

Acidity— Dissolve 1.0g in 20mLof water,add 1drop of methyl red TS,and titrate with 0.020Nsodium hydroxide:not more than 0.30mLis required to produce a yellow color.

Water,Method Iá921ñ: not more than 4.0%.

Residue on ignition á281ñ: not more than 0.2%.

Organic volatile impurities,Method Iá467ñ: meets the requirements.

Other alkaloids— Dissolve 150mg in 10mLof water.To 5mLof the solution add a few drops of platinic chloride TS:no precipitate is formed.To the remaining 5mLof the solution add 2mLof 6Nammonium hydroxide,and shake vigorously:a slight opalescence may develop but no turbidity is produced.

Assay— Dissolve about 1g of Atropine 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.

Expert Committee:(PA3)Pharmaceutical Analysis 3

USP28–NF23Page 200

Phone Number:1-301-816-8330