Procedure—
Separately inject equal volumes (about 20 µL) of the
Standard preparation and the
Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of C
18H
27NO
2·HCl in each mL of the Topical Solution taken by the formula:
500(C / V)(rU / rS),
in which
C is the concentration, in mg per mL, of
USP Dyclonine Hydrochloride RS in the
Standard preparation,
V is the volume, in mL, of the Topical Solution taken, and
rU and
rS are the peak responses obtained from the
Assay preparation and the
Standard preparation, respectively.
for 1 hour: the dyclonine hydrochloride so obtained responds to the Identification tests under Dyclonine Hydrochloride.
71
:
meets the requirements.