Ergonovine Maleate Injection
» Ergonovine Maleate Injection is a sterile solution of Ergonovine Maleate in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C19H23N3O2·C4H4O4.
Packaging and storage Preserve in single-dose, light-resistant containers, preferably of Type I glass, and store in a cold place.
USP Reference standards 11
USP Endotoxin RS
Identification The RF value of the principal blue spot obtained from the Test preparation corresponds to that obtained from Standard preparation A in the chromatogram prepared as directed in the test for Related alkaloids.
Bacterial endotoxins 85 It contains not more than 700.0 USP Endotoxin Units per mg of ergonovine maleate.
pH 791: between 2.7 and 3.5.
Related alkaloids [noteConduct this test promptly, without exposure to daylight and with minimum exposure to artificial light. ]
Solvent mixture, Standard preparation, and Standard dilutions Prepare as directed in the test for Related alkaloids under Ergonovine Maleate.
Test preparation Immediately prior to use, transfer a volume of Injection, equivalent to about 5 mg of ergonovine maleate, to a separator, and extract with three 5-mL portions of chloroform. Discard the chloroform extracts. Render alkaline to litmus with 6 N ammonium hydroxide, and extract with three 5-mL portions of chloroform. Evaporate the combined extracts with the aid of a stream of nitrogen, but without heat, to dryness. Dissolve the residue so obtained in 0.5 mL of Solvent mixture.
Other requirements It meets the requirements under Injections 1.
0.05 M Phosphate buffer Dissolve 6.8 g of monobasic potassium phosphate in 600 mL of water and adjust with phosphoric acid to a pH of 2.1. Dilute with water to 1000 mL, and mix.
Mobile phase Prepare a suitable and degassed solution of 0.05 M Phosphate buffer and acetonitrile (80:20) such that the retention time is approximately 3 minutes with a flow rate of 1 mL per minute.
Standard preparation Dissolve an accurately weighed quantity of USP Ergonovine Maleate RS in Mobile phase, adding sufficient water to equal 10% of the final volume, to obtain a solution having a known concentration of about 0.02 mg per mL.
Assay preparation Quantitatively dilute an accurately measured volume of the Injection, equivalent to about 2 mg of ergonovine maleate, with Mobile phase and water, if necessary, to obtain a solution having a concentration of about 0.02 mg per mL in which the Injection volume plus any added water constitutes 10% of the final volume.
Chromatographic system (see Chromatography 621)The liquid chromatograph is equipped with a 312-nm detector and a 3-mm × 30-cm column that contains packing L1. Chromatograph five replicate injections of the Standard preparation, and record the peak responses as directed under Procedure: the relative standard deviation is not more than 3.0%.
Procedure By means of a suitable sampling valve, introduce equal volumes (about 100 µL) of the Assay preparation and the Standard preparation into the chromatograph. Measure the peak responses of Ergonovine Maleate, at corresponding retention times, obtained from the Assay preparation and the Standard preparation. Calculate the quantity, in mg, of C19H23N3O2·C4H4O4 in each mL of the Injection taken by the formula:
(CD / V)(rU / rS)in which C is the concentration, in mg per mL, of USP Ergonovine Maleate RS in the Standard preparation, V is the volume, in mL, of Injection taken, D is the dilution factor, and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 3071