Ergoloid Mesylates Oral Solution
»Ergoloid Mesylates Oral Solution contains not less than 90.0percent and not more than 110.0percent of the labeled amount of Ergoloid Mesylates,consisting of not less than 30.3percent and not more than 36.3percent of the methanesulfonate salt of each of the individual alkaloids (dihydroergocristine,dihydroergocornine,and dihydroergocryptine).The ratio of alpha-to beta-dihydroergocryptine mesylate is not less than 1.5:1.0and not more than 2.5:1.0.
Packaging and storage— Preserve in tight,light-resistant containers.Store at a temperature not exceeding 30.
Identification— The retention times of the major peaks in the chromatogram of the Assay preparationcorrespond to those in the chromatogram of the Standard preparation,as obtained in the Assay.
Uniformity of dosage units á905ñ—
FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume á698ñ—
FOR ORAL SOLUTION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.
Alcohol content,Method IIá611ñ: between 90.0%and 110.0%of the labeled amount of C2H5OH.
Assay—
Mobile phase and Chromatographic system— Prepare as directed in the Assayunder Ergoloid Mesylates.
Standard preparation— Dissolve an accurately weighed quantity of USP Ergoloid Mesylates RSin acetonitrile solution (1in 5)to obtain a solution having a known concentration of about 0.25mg per mL.
Assay preparation— Transfer an accurately measured volume of Oral Solution,equivalent to about 25mg of ergoloid mesylates,to a 100-mLvolumetric flask.Rinse the pipet with small portions of acetonitrile solution (1in 5),collecting the rinsings in the volumetric flask.Dilute with acetonitrile solution (1in 5)to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Ergoloid Mesylates,except to inject about 60-µLvolumes of the Assay preparationand the Standard preparation.Calculate the quantity,in mg,of ergoloid mesylates in each mLof the Oral Solution taken by the formula:
100(C/V)(rU/rS),
in which Vis the volume,in mL,of Oral Solution taken,and the other terms are as defined therein.
Calculate the percentage of each of the individual alkaloids in the Oral Solution taken by the formula given in the Assayunder Ergoloid Mesylates.
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 750
Pharmacopeial Forum:Volume No.29(6)Page 1884
Phone Number:1-301-816-8330