Packaging and storage—
Preserve in well-closed, light-resistant containers. Store at 25
, excursions permitted between 15
and 30
.
Identification—
A:
Infrared Absorption 
197K
.
C:
The retention time of the morantel peak in the chromatogram of the Test solution corresponds to that in the chromatogram of Standard solution 1, as obtained in the test for Related compounds.
Related compounds—
[Note—Conduct this test without exposure to daylight, and with the minimum necessary exposure to artificial light.
]
Mobile phase—
Mix 3.5 mL of triethylamine and 850 mL of water. Adjust with phosphoric acid to a pH of 2.5. Add 50 mL of tetrahydrofuran and 100 mL of methanol, and mix.
Tartrate solution—
Prepare a solution containing about 0.15 mg of tartaric acid per mL in Mobile phase.
Standard solution 1—
Dissolve an accurately weighed quantity of
USP Morantel Tartrate RS in
Mobile phase to obtain a solution having a known concentration of about 5.0 µg per mL.
Standard solution 2—
Dilute 2.0 mL of Standard solution 1 to 100.0 mL with Mobile phase.
System suitability solution—
Expose 10 mL of Standard solution 1 to daylight for 15 minutes before injection.
Test solution—
Dissolve an accurately weighed quantity of Morantel Tartrate in Mobile phase to obtain a solution having a concentration of about 0.5 mg per mL.
Chromatographic system (see Chromatography 621)—
The liquid chromatograph is equipped with a 226-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L1. The flow rate is about 0.75 mL per minute. Chromatograph the
Tartrate solution, Standard solution 1, and
System suitability solution, and record the peak areas as directed for
Procedure: using the
System suitability solution, the resolution,
R, between morantel and its preceding peak (
(Z)-isomer) is not less than 2.
Procedure—
Separately inject equal volumes (about 20 µL) of the
Tartrate solution, Standard solution 1, Standard solution 2, and the
Test solution into the chromatograph, record the chromatograms, and measure the areas for the major peaks. Disregarding the tartrate peak and any peak in the chromatogram of the
Test solution less than the area of the principal peak in the chromatogram of
Standard solution 2, calculate the area percentage of each impurity, relative to morantel, in the portion of Morantel Tartrate taken by the formula:
100(CS / CU)(ri / rS),
in which
CS and
CU are the concentrations of morantel tartrate, in mg per mL, of
Standard solution 1 and the
Test solution, respectively; and
ri and
rS are the peak areas of each individual impurity and morantel obtained from the
Test solution and
Standard solution 1, respectively: not more than 0.5% of any individual impurity is found, and not more than 1% of total impurities is found.
;)
