alcohol hydrochloride [61-76-7].
Packaging and storage—
Preserve in tight,
light-resistant containers. Store at 25
excursions permitted between 15
A: Infrared Absorption á197Kñ.
B: A solution (1 in 100) responds to the
tests for Chloride á191ñ.
A solution of 50 mg in 25 mL of water shows no more turbidity than
corresponds to 0.10 mL of 0.020 N sulfuric acid (0.20%).
Limit of ketones— Dissolve 200 mg in 1 mL of
water, add 2 drops of sodium nitroferricyanide TS, then add 1 mL of 1 N
sodium hydroxide, followed by 0.6 mL of glacial acetic acid: the color of
the final solution is not deeper than that obtained in a control solution
prepared with 1 mL of dilute acetone (1 in 2000).
accurately weighed quantity of USP
Phenylephrine Hydrochloride RS
in methanol to obtain a
solution having a known concentration of 1 mg per mL. Quantitatively
dilute with methanol to obtain Standard preparations
having the following compositions:
||(1 in 2)
||(1 in 4)
||(1 in 10)
||(1 in 20)
Test preparation— Dissolve an accurately
weighed quantity of Phenylephrine Hydrochloride in methanol to
obtain a solution containing 50 mg per mL.
Apply separately 5 µL
of the Test preparation
and 5 µL of
each Standard preparation
to a suitable
thin-layer chromatographic plate (see Chromatography
coated with a 0.25-mm layer of chromatographic silica gel mixture.
Position the plate in a chromatographic chamber and develop the
chromatograms in a solvent system consisting of a mixture of n
alcohol, water, and formic acid (7:2:1) 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 in warm, circulating air. Examine the plate
under short-wavelength UV light. Then spray the plate with a
saturated solution of p
tetrafluoroborate followed by sodium carbonate solution (1 in 10).
Compare the intensities of any secondary spots observed in the
chromatogram of the Test preparation
those of the principal spots in the chromatograms of the Standard
the sum of the intensities of secondary spots
obtained from the Test preparation
corresponds to not more than 1.0% of related compounds, with no
single impurity corresponding to more than 0.5%.
Chloride content— Dissolve about 300 mg,
accurately weighed, in 5 mL of water. Add 5 mL of glacial acetic acid
and 50 mL of methanol, then add eosin Y TS, and titrate with 0.1 N
silver nitrate VS. Each mL of 0.1 N silver nitrate is equivalent to
3.545 mg of Cl. Not less than 17.0% and not more than 17.7% of Cl is
found, calculated on the dried basis.
Dissolve about 100 mg of
Phenylephrine Hydrochloride, accurately weighed, in 20 mL of water
contained in an iodine flask, add 50.0 mL of 0.1 N bromine VS, then
add 5 mL of hydrochloric acid, and immediately insert the stopper.
Shake the flask, and allow to stand for 15 minutes. Introduce quickly
10 mL of potassium iodide solution (1 in 10), allow to stand for 5
minutes, shake thoroughly, remove the stopper, and rinse it and the
neck of the flask with a small quantity of water into the flask.
Titrate the liberated iodine with 0.1 N sodium thiosulfate VS, adding
3 mL of starch TS as the endpoint is approached. Perform a blank
determination (see Residual Titrations
Each mL of 0.1 N bromine is equivalent to 3.395 mg of C9
Auxiliary Information— Staff
: Daniel K. Bempong, Ph.D.,
Expert Committee : (PA2) Pharmaceutical
USP28–NF23 Page 1541
: Volume No. 29(6) Page
Phone Number : 1-301-816-8143