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Quinidine Gluconate Injection
» Quinidine Gluconate Injection is a sterile solution of Quinidine Gluconate in Water for Injection. It contains, in each mL, amounts of quinidine gluconate and dihydroquinidine gluconate totaling not less than 76 mg and not more than 84 mg of quinidine gluconate, calculated as C20H24N2O2·C6H12O7.
Packaging and storage— Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.
Identification—
A: A 1 in 150 solution of Injection in dilute sulfuric acid (1 in 350) exhibits a vivid blue fluorescence. On the addition of a few drops of hydrochloric acid, the fluorescence disappears.
B: A solution of Injection (1 in 4) is dextrorotatory.
C: In the test for Chromatographic purity, the RF value of the principal spot obtained from the Test preparation corresponds to that from the Standard preparation.
Bacterial endotoxins 85— It contains not more than 0.6 USP Endotoxin Unit per mg of quinidine gluconate.
Chromatographic purity— Mix an accurately measured volume of Injection, equivalent to 80 mg of quinidine gluconate, with 25 mL of water, add 2 drops of 2 N sulfuric acid, and extract with 50 mL of ether, discarding the ether extract. To the aqueous solution add 2 mL of 1 N sodium hydroxide, extract with 50 mL of ether, wash the extract with 25 mL of water, and discard the aqueous solutions. Evaporate the ether extract just to dryness, and dissolve the residue in 10 mL of alcohol. Using this as the test solution, proceed as directed in the test for Chromatographic purity under Quinidine Gluconate, beginning with “Apply 10-µL portions of the Test preparation.”
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay—
Methanesulfonic acid solution , Diethylamine solution, Mobile phase, System suitability preparation, and System suitability test—Proceed as directed in the test for Limit of dihydroquinidine gluconate under Quinidine Gluconate.
Standard preparation— Transfer about 26 mg of USP Quinidine Gluconate RS, accurately weighed, to a 100-mL volumetric flask, dissolve in and dilute with Mobile phase to volume, and mix.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 400 mg of quinidine gluconate, to a 50-mL volumetric flask, add methanol to volume, and mix. Transfer 3.0 mL of this solution to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure (see Chromatography 621)—Inject equal volumes (about 50 µL) of the Standard preparation and the Assay preparation into a chromatograph equipped with a 235-nm detector and a 3.9-mm × 30-cm column that contains packing L1. Calculate the quantity, in mg, of the Sum of quinidine gluconate and dihydroquinidine gluconate in each mL of the Injection taken by the formula:
(5000 / 3)(C / V)(rb,U + rd,U) / (rb,S + rd,S),
in which C is the concentration, in mg per mL, of USP Quinidine Gluconate RS in the Standard preparation, V is the volume, in mL, of Injection taken, rb,U and rb,S are the peak responses of quinidine obtained from the Assay preparation and the Standard preparation, respectively, and rd,U and rd,S are the peak responses of dihydroquinidine obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Andrzej Wilk, Ph.D., Senior Scientific Associate
Expert Committee : (MDCV05) Monograph Development-Cardiovascular
USP29–NF24 Page 1880
Phone Number : 1-301-816-8305