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Triprolidine Hydrochloride
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C19H22N2·HCl·H2O 332.87

Pyridine, 2-[1-(4-methylphenyl)-3-(1-pyrrolidinyl)-1-propenyl]-, monohydrochloride, monohydrate, (E)-.
(E)-2-[3-(1-Pyrrolidinyl)-1-p-tolylpropenyl]pyridine monohydrochloride monohydrate [6138-79-0].

Anhydrous 314.86 [550-70-9].
» Triprolidine Hydrochloride contains not less than 98.0 percent and not more than 101.0 percent of C19H22N2·HCl, calculated on the anhydrous basis.
Packaging and storage— Preserve in tight, light-resistant containers.
Solution: 10 µg per mL.
Medium: 0.1 N hydrochloric acid.
Absorptivities at 290 nm, calculated on the anhydrous basis, do not differ by more than 3.0%.
C: A solution of it responds to the tests for Chloride 191.
Water, Method I 921: between 4.0% and 6.0%.
Residue on ignition 281: not more than 0.1%.
Heavy metals, Method II 231: 0.002%.
Chromatographic purity—
Standard preparations— Dissolve USP Triprolidine Hydrochloride RS in chloroform, and mix to obtain a solution having a known concentration of 1.0 mg per mL. Dilute quantitatively with chloroform to obtain four diluted Standard preparations (A, B, C, and D) having the following compositions:
Dilution Concentration
(µg RS per mL)
Percentage (%,
for comparison
with test
A (1 in 5) 200 2.0
B (15 in 100) 150 1.5
C (1 in 10) 100 1.0
D (5 in 100) 50 0.5
Standard Z-isomer preparations— Proceed as directed for Standard preparations, using USP Triprolidine Hydrochloride Z-isomer RS to obtain four diluted Standard preparations having the same compositions as in the table shown therein.
Test preparation— Dissolve an accurately weighed quantity of Triprolidine Hydrochloride in chloroform to obtain a solution containing 10 mg per mL.
Procedure— Apply separately 5 µL of the Test preparation and 5 µL of each of the eight diluted Standard to a suitable thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture. Position the plate in a chromatographic chamber, and develop the chromatograms, protected from light, in a solvent system consisting of a mixture of chloroform and diethylamine (95:5) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, and allow the solvent to evaporate. Examine the plate under long- and short-wavelength UV light. Compare the intensities of any secondary spots observed in the chromatogram of the Test preparation with those of the principal spots in the chromatograms of the Standard preparations: the intensity of the Z-isomer triprolidine hydrochloride spot (RF value about 1.2 relative to the RF value for triprolidine hydrochloride) obtained from the Test preparation corresponds to not more than 2.0%, and the sum of the intensities of all secondary spots obtained from the Test preparation corresponds to not more than 3.0%.
Organic volatile impurities, Method V 467: meets the requirements.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 400 mg of Triprolidine Hydrochloride, accurately weighed, in 80 mL of glacial acetic acid, warming, if necessary, to effect solution. Add 15 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 15.74 mg of C19H22N2·HCl.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 2216
Phone Number : 1-301-816-8143