Click to View Image
C19H28BrNO3 398.33

Pyrrolidinium, 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl-, bromide.
3-Hydroxy-1,1-dimethylpyrrolidinium bromide -cyclopentylmandelate [596-51-0].
» Glycopyrrolate, dried at 105 for 3 hours, contains not less than 98.0 percent and not more than 100.5 percent of C19H28BrNO3.
Packaging and storage— Preserve in tight containers.
Solution: 500 µg per mL.
Medium: water.
Absorptivities at 258 nm, calculated on the dried basis, do not differ by more than 3.0%.
C: A solution (1 in 40) responds to the tests for Bromide 191.
Melting range, Class I 741: between 193 and 198, but the range between beginning and end of melting does not exceed 2.
Loss on drying 731 Dry it at 105 for 3 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.3%.
Ordinary impurities 466
Test solution: 50 mg per mL in alcohol.
Standard solutions: 0.05 mg per mL, 0.25 mg per mL, 0.5 mg per mL, and 1.0 mg per mL in alcohol.
Eluant: a mixture of ethyl acetate, water, and anhydrous formic acid (74:16:10).
Application volume: 5 µL.
Adsorbent: chromatographic silica gel.
Visualization— Dry the plate at 105 for 15 minutes, followed by Visualization Technique 3; then air-dry the developed plate at room temperature for 2 hours.
Limits— The intensity of any secondary spot obtained from the Test solution corresponds to not more than 0.5%, and the sum of the intensities of all secondary spots obtained from the Test solution corresponds to not more than 2.0%.
Assay— Dissolve about 800 mg of Glycopyrrolate, previously dried and accurately weighed, in 50 mL of glacial acetic acid, add 10 mL of mercuric acetate TS and 1 drop of crystal violet TS, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 39.83 mg of C19H28BrNO3.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Elena Gonikberg, Ph.D.
Senior Scientist
(MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 2516
Pharmacopeial Forum: Volume No. 29(5) Page 1503