Dyclonine Hydrochloride
;)
1-Propanone,1-(4-butoxyphenyl)-3-(1-piperidinyl)-.
4¢-Butoxy-3-piperidinopropiophenone hydrochloride [536-43-6].
»Dyclonine Hydrochloride contains not less than 98.0percent and not more than 102.0percent of C18H27NO2·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
Identification—
A:
Infrared Absorption á197Mñ.
Solution:
25µg per mL.
Medium:
methanol.
C:
Add 2mLof silver nitrate TSto 10mLof Dyclonine Hydrochloride solution (1in 100):a white precipitate is formed.Add 2mLof nitric acid,centrifuge,and discard the supernatant.Wash the precipitate twice by adding 10mLof 2Nnitric acid,centrifuging,and discarding the supernatant:the precipitate so obtained is soluble in 6Nammonium hydroxide.
pHá791ñ:
between 4.0and 7.0,in a solution (1in 100).
Loss on drying á731ñ—
Dry it at 105
for 1hour:it loses not more than 1.0%of its weight.
for 1hour:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ:
not more than 0.2%.
Assay—
Mobile phase,Standard preparation,and Chromatographic system—
Proceed as directed in the Assayunder Dyclonine Hydrochloride Gel.
Assay preparation—
Transfer about 50mg of Dyclonine Hydrochloride,accurately weighed,to a 500-mLvolumetric flask,dissolve in 0.001Nphosphoric acid,dilute with 0.001Nphosphoric acid to volume,and mix.
Procedure—
Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of dyclonine hydrochloride (C18H27NO2·HCl)in the portion of Dyclonine Hydrochloride taken by the formula:
500C(rU/rS),
in which Cis the concentration,in mg per mL,of USP Dyclonine Hydrochloride RSin the Standard preparation,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information—
Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 706
Phone Number:1-301-816-8379