Erythromycin Ethylsuccinate Oral Suspension
»Erythromycin Ethylsuccinate Oral Suspension is a suspension of Erythromycin Ethylsuccinate containing one or more suitable buffers,colors,dispersants,flavors,and preservatives.It contains the equivalent of not less than 90.0percent and not more than 120.0percent of the labeled amount of erythromycin (C37H67NO13).
Packaging and storage—
Preserve in tight containers,and store in a cold place.
Identification—
To a quantity of the Oral Suspension add a volume of methanol sufficient to yield a solution having a concentration equivalent to about 2.5mg of erythromycin per mL.Shake this mixture by mechanical means for about 30minutes.Centrifuge a portion of this mixture,and use the clear supernatant as the test solution.Prepare a Standard solution of USP Erythromycin Ethylsuccinate RSin methanol containing about 3mg per mL.Apply separately 10µLeach of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel mixture,and allow to dry.Place the plate in an unlined chromatographic chamber,and develop the chromatograms in a solvent system consisting of a mixture of methanol and chloroform (85:15)until the solvent front has moved about 9cm.Remove the plate from the chamber,mark the solvent front,and allow the solvent to evaporate.Spray the plate with a mixture of dehydrated alcohol,p-methoxybenzaldehyde,and sulfuric acid (90:5:5).Heat the plate at 100
for 10minutes,and examine the chromatograms,in which the erythromycin and succinic acid moieties appear as black-to-purple spots:the RFvalues of the principal spots obtained from the test solution correspond to those obtained from the Standard solution.
for 10minutes,and examine the chromatograms,in which the erythromycin and succinic acid moieties appear as black-to-purple spots:the RFvalues of the principal spots obtained from the test solution correspond to those obtained from the Standard solution.
Uniformity of dosage units á905ñ—
FOR SUSPENSION PACKAGED IN SINGLE-UNIT CONTAINERS
:meets the requirements.
Deliverable volume á698ñ:
meets the requirements.
pHá791ñ:
between 6.5and 8.5.
Assay—
Proceed as directed for erythromycin under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Oral Suspension,freshly mixed and free from air bubbles,blended for 4±1minutes in a high-speed glass blender jar with sufficient methanol to give a stock solution containing the equivalent of about 1mg of erythromycin per mL.Dilute this stock solution quantitatively with Buffer No.3to obtain a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information—
Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 767
Phone Number:1-301-816-8335