Procyclidine Hydrochloride
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C19H29NO·HCl 323.90

1-Pyrrolidinepropanol, -cyclohexyl--phenyl-, hydrochloride.
-Cyclohexyl--phenyl-1-pyrrolidinepropanol hydrochloride [1508-76-5].
» Procyclidine Hydrochloride contains not less than 99.0 percent and not more than 101.0 percent of C19H29NO·HCl, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers, and store in a dry place.
USP Reference standards 11
USP Procyclidine Hydrochloride RS
B: Dissolve about 250 mg in 10 mL of water in a separator, render alkaline with 6 N ammonium hydroxide, and extract with three 10-mL portions of ether. Filter the ether extracts slowly through a layer of about 2 g of anhydrous granular sodium sulfate supported on glass wool, evaporate the ether with a current of warm air, and scratch the surface of the container to induce crystallization of the residue: the procyclidine so obtained melts between 83 and 87, the procedure for Class I being used (see Melting Range or Temperature 741).
C: A solution (1 in 100) responds to the tests for Chloride 191.
pH 791: between 5.0 and 6.5, in a solution (1 in 100).
Loss on drying 731 Dry it in vacuum at 105 for 4 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.1%.
Related compounds— Dissolve approximately 200 mg of Procyclidine Hydrochloride in 20 mL of water, and render the solution alkaline by adding 1.5 mL of 6 N ammonium hydroxide. Extract with three 15-mL portions of chloroform, wash the combined extracts with 20 mL of water, discard the water washing, and filter the chloroform solution through a layer of 3 to 4 g of anhydrous granular sodium sulfate supported on glass wool. Reduce the volume to 5 mL by evaporating with the aid of gentle heat and a current of air. Inject 2 µL of this solution into a suitable gas chromatograph (see Chromatography 621) equipped with a flame-ionization detector, and record the chromatogram to 2.5 relative to the retention time of the principal (procyclidine) peak. Under typical conditions, the instrument contains a 1-m × 2-mm glass column packed with 10% polyethylene glycol 20,000 and 2% potassium hydroxide on packing S1A. The column is maintained at a temperature of about 180, the injection port is maintained at 210, the detector block is maintained at about 220, and dry helium is used as the carrier gas at a flow rate of about 60 mL per minute. From the total area under the curve, excluding the solvent peak, calculate the percentage of total impurities by area normalization: not more than 4.0% is found.
Assay— Dissolve about 700 mg of Procyclidine Hydrochloride, accurately weighed, in 75 mL of glacial acetic acid in a 250-mL beaker, warming, if necessary, to effect solution. Cool, add 10 mL of mercuric acetate TS, 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 32.39 mg of C19H29NO·HCl.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3398
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.