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Ergoloid Mesylates Oral Solution
» Ergoloid Mesylates Oral Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of Ergoloid Mesylates, consisting of not less than 30.3 percent and not more than 36.3 percent 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 1.5:1.0 and 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 preparation correspond to those in the chromatogram of the Standard preparation, as obtained in the Assay.
Uniformity of dosage units 905—
FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume 698—
FOR ORAL SOLUTION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.
Alcohol content, Method II 611: between 90.0% and 110.0% of the labeled amount of C2H5OH.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Mobile phase and Chromatographic system— Prepare as directed in the Assay under Ergoloid Mesylates.
Standard preparation— Dissolve an accurately weighed quantity of USP Ergoloid Mesylates RS in acetonitrile solution (1 in 5) to obtain a solution having a known concentration of about 0.25 mg per mL.
Assay preparation— Transfer an accurately measured volume of Oral Solution, equivalent to about 25 mg of ergoloid mesylates, to a 100-mL volumetric flask. Rinse the pipet with small portions of acetonitrile solution (1 in 5), collecting the rinsings in the volumetric flask. Dilute with acetonitrile solution (1 in 5) to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Ergoloid Mesylates, except to inject about 60-µL volumes of the Assay preparation and the Standard preparation. Calculate the quantity, in mg, of ergoloid mesylates in each mL of the Oral Solution taken by the formula:
100(C/V)(rU / rS),
in which V is 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 Assay under Ergoloid Mesylates.
Auxiliary Information— Staff Liaison : Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 817
Pharmacopeial Forum : Volume No. 29(6) Page 1884
Phone Number : 1-301-816-8330