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Printed by: Le Tran Official Date: Official as of 01-Aug-2017 Document Type: USP @2021 USPC
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not less than 2.0; the tailing factor for ondansetron related
Ondansetron Oral Solution compound D is not more than 2.0; and the relative standard
deviation for replicate injections is not more than 4.0%.
» Ondansetron Oral Solution is a solution of Procedure—Separately inject equal volumes (about 20 µL)
of the Standard solution and the Test solution into the
Ondansetron Hydrochloride in a suitable vehicle. It chromatograph, record the chromatograms, and measure the
contains not less than 95.0 percent and not more responses for the major peaks. Calculate the percentage of
than 105.0 percent of the labeled amount of ondansetron related compound D in the volume of Oral
ondansetron (C18H19N3O). Solution taken by the formula:

Packaging and storage—Preserve in well-closed, 100D(C S/C A)(r U/r S)

light-resistant containers.
USP Reference standards á11ñ— in which D is the dilution factor for the Oral Solution in the
USP Ondansetron Hydrochloride RS Test solution; C S is the concentration, in µg per mL, of USP
USP Ondansetron Related Compound A RS Ondansetron Related Compound D RS in the Standard
3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9- solution; C A is the concentration, in µg per mL, of ondansetron
methyl-4H-carbazol-4-one hydrochloride. in the Oral Solution, as determined in the Assay; and r U and r S
USP Ondansetron Related Compound C RS are the peak responses of ondansetron related compound D
1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-one. obtained from the Test solution and the Standard solution,
USP Ondansetron Related Compound D RS respectively: not more than 0.1% is found.
1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol- Related compounds—
4-one. Mobile phase, System suitability solution, and

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Identification— Chromatographic system—Proceed as directed in the Assay
A: Thin-Layer Chromatographic Identification Test á201ñ— under Ondansetron Hydrochloride.
Test solution—Dilute a portion of Oral Solution with a mixture Standard solution—Prepare as directed for the Standard
of methanol and water (50:50) to obtain a solution containing preparation, in the Assay under Ondansetron Hydrochloride.
about 0.2 mg of ondansetron per mL. Test solution—Use the Assay preparation.
Standard solution: 0.25 mg per mL in methanol.
Developing solvent system: chloroform, ethyl acetate,
methanol, and ammonium hydroxide (90:50:40:1).
ci Procedure—Separately inject equal volumes (about 10 µL)
of the Standard solution and the Test solution into the
chromatograph, record the chromatograms, and measure the
B: The retention time of the major peak in the peak responses. Calculate the percentage of each related
chromatogram of the Assay preparation corresponds to that in compound in the volume of Oral Solution taken by the
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the chromatogram of the Standard preparation, as obtained formula:
in the Assay.
Microbial enumeration tests á61ñ and Tests for specified (293.36/329.83)10,000(1/F)(1/V)(C S/C A)(r i/r S)
microorganisms á62ñ—It meets the requirements of the tests
for absence of Escherichia coli. The total aerobic microbial in which 293.36 and 329.83 are the molecular weights of
count does not exceed 100 cfu per g, the Enterobacteriaceae ondansetron and anhydrous ondansetron hydrochloride,
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count does not exceed 10 cfu per g, and the total combined respectively; F is the relative response factor for each known
molds and yeasts count does not exceed 50 cfu per g. and unknown impurity (the values of relative response factors
Deliverable volume á698ñ: meets the requirements. [RRF] and the limits can be obtained from Table 1); V is the
pH á791ñ: between 3.3 and 4.0. volume, in mL, of Oral Solution taken; C S is the concentration,
in mg per mL, on the anhydrous basis, of USP Ondansetron
Limit of ondansetron related compound D— Hydrochloride RS in the Standard solution; C A is the
Mobile phase—Proceed as directed in the test for Limit of concentration, in mg per mL, of ondansetron in the Oral
ondansetron related compound D under Ondansetron Solution; r i is the peak response for any related compound
Hydrochloride. obtained from the Test solution; and r S is the peak response
System suitability solution—Dissolve suitable quantities of
for ondansetron obtained from the Standard solution.
USP Ondansetron Related Compound D RS and USP
Ondansetron Related Compound C RS in Mobile phase; and Table 1
dilute quantitatively, and stepwise if necessary, with
Mobile phase to obtain a solution containing about 0.5 µg per Approx. Limit
Related Compound RRT RRF (%)
mL and 2 µg per mL, respectively.
Standard solution—Dissolve an accurately weighed quantity Ondansetron related compound D* 0.34 — 0.1
of USP Ondansetron Related Compound D RS in Mobile phase; Imidazole 0.40 0.46 0.2
and dilute quantitatively, and stepwise if necessary, with
Mobile phase to obtain a solution having a known 2-Methyl imidazole 0.53 0.54 0.2
concentration of about 0.5 µg per mL. Des-C-methyl ondansetron hydrochloride 0.62 0.76 0.2
Test solution—Quantitatively dilute, if necessary, an
accurately measured volume of Oral Solution with N-Desmethyl ondansetron maleate 0.83 0.73 0.2
Mobile phase to obtain a solution containing about 0.8 mg of Ondansetron related compound A 1.2 0.81 0.2
ondansetron per mL.
Unknown 1.0 0.2
Chromatographic system (see Chromatography á621ñ)—The
liquid chromatograph is equipped with a 328-nm detector Total (including ondansetron related com- — 0.5
and a 4.6-mm × 25-cm column that contains packing L10. The pound D)
flow rate is about 1.5 mL per minute. Chromatograph the * Quantified from Limit of related compound D test
System suitability solution, and record the peak responses as
directed for Procedure: the resolution, R, between ondansetron
related compound D and ondansetron related compound C is

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Printed by: Le Tran Official Date: Official as of 01-Aug-2017 Document Type: USP @2021 USPC
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Assay— more than 2.0, and the relative standard deviation for replicate
Mobile phase, System suitability solution, Standard injections is not more than 2.0%.
preparation, and Chromatographic system—Proceed as Procedure—Separately inject equal volumes (about 10 µL)
directed in the Assay under Ondansetron Hydrochloride. of the Standard preparation and the Assay preparation into the
Assay preparation—Transfer an accurately measured chromatograph, record the chromatograms, and measure the
volume of Oral Solution, equivalent to about 9 mg of responses for the major peaks. Calculate the quantity, in mg,
ondansetron, to a 100-mL volumetric flask; dilute with of ondansetron (C 18 H 19 N 3 O) in each mL of Oral Solution
Mobile phase to volume; and mix. taken by the formula:
Chromatographic system (see Chromatography á621ñ)—The
liquid chromatograph is equipped with a 216-nm detector (293.36/329.83)100(C/V)(r U/r S)
and a 4.6-mm × 25-cm column that contains packing L10. The
flow rate is about 1.5 mL per minute. Chromatograph the in which 293.36 and 329.83 are the molecular weights of
System suitability solution, and record the peak responses as ondansetron and anhydrous ondansetron hydrochloride,
directed for Procedure: the relative retention times are about respectively; C is the concentration, in mg per mL, on the
1.1 for ondansetron related compound A and 1.0 for anhydrous basis, of USP Ondansetron Hydrochloride RS in the
ondansetron; and the resolution, R, between ondansetron Standard preparation; V is the volume, in mL, of Oral Solution
related compound A and ondansetron is not less than 1.5. taken; and r U and r S are the peak responses obtained from the
Chromatograph the Standard preparation, and record the peak Assay preparation and the Standard preparation, respectively.
responses as directed for Procedure: the tailing factor is not

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