Atropine Sulfate
(at' roe peen sul' fate).
(C17H23NO3)2·H2SO4·H2O
694.83
694.83Benzeneacetic acid,
-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester, endo-(±)-, sulfate (2:1) (salt), monohydrate.
1
H,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.
USP Reference standards 
11
—
11—
USP Atropine Sulfate RS 
') + '&img=../../images/v35300/cas-5908-99-6.gif',600,500);)
Identification—
B:
A solution (1 in 20) meets the requirements of the tests for Sulfate 191.
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. ]
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).
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%.
921:
not more than 4.0%.
Residue on ignition 281:
not more than 0.2%.
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.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ravi Ravichandran, Ph.D.
Principal Scientific Liaison 1-301-816-8330 |
(SM42010) Monographs - Small Molecules 4 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2270
Pharmacopeial Forum: Volume No. 35(4) Page 829