»Yohimbine Injection is a sterile solution of Yohimbine Hydrochloride in Water for Injection.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of yohimbine (C21H26N2O3).
Packaging and storage
Preserve in single-dose or multiple-dose Containers for Injectionsas described under Injections á1ñ,and store at controlled room temperature.
Where it is intended for veterinary use only,it is so labeled.
USP Reference standards á11ñ
USP Endotoxin RS.USP Yohimbine Hydrochloride RS.
Identification,Thin-Layer Chromatographic Identification Test á201ñ
Transfer a volume of Injection,equivalent to about 40mg of yohimbine,to a separator,add 5mLof a sodium carbonate solution (1in 20),and extract with four 10-mLportions of chloroform,combining the chloroform extracts in a beaker and evaporating to dryness.Add 20mLof methanol to the beaker,and swirl to dissolve the residue.
Prepare a solution of USP Yohimbine Hydrochloride RSin methanol containing 2mg per mL.
a mixture of the Test solutionand the Standard solution(1:1).
Developing solvent system:
methylene chloride,methanol,and ammonium hydroxide (90:14:1),in a saturated chamber.
Allow the plate to air-dry in a hood.Expose the dry plate for 30minutes to short-wavelength UVlight,then examine under long-wavelength UVlight:the size,intensity,and RFvalue of the principal spots in the chromatograms obtained from the Test solutionand the Mixed solutioncorrespond to those characteristics of the principal spot in the chromatogram obtained from the Standard solution.
Bacterial endotoxins á85ñ
It contains not more than 45.5USP Endotoxin Units per mg of yohimbine.
It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
between 3.7and 4.3.
It meets the requirements under Injections á1ñ.
Prepare a mixture of acetonitrile,water,and glacial acetic acid (49:49:2).
Prepare a mixture of water,acetonitrile,and glacial acetic acid (603:377:20)containing 3.5g of sodium 1-decanesulfonate in each 1000mL.Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Transfer about 55mg of USP Yohimbine Hydrochloride RS,accurately weighed,to a 25-mLvolumetric flask,add 40mLof water,warm,and swirl to dissolve.Add 84mg of anhydrous citric acid,and swirl to dissolve.Allow the solution to cool,adjust with 1Nsodium hydroxide to a pHof 4.0,dilute with water to volume,and mix.Transfer 125.0µLof this stock solution to a second 25-mLvolumetric flask,dilute with Diluentto volume,and mix.This solution contains about 0.011mg of USP Yohimbine Hydrochloride RSper mL.
Prepare a solution in methanol containing about 0.56mg of methylparaben and 0.06mg of propylparaben per mL.Transfer 200µLof this solution to a 25-mLvolumetric flask,add 125.0µLof the stock solution used to prepare the Standard preparation,dilute with Diluentto volume,and mix.
Transfer an accurately measured volume of Injection,equivalent to about 0.25mg of yohimbine,to a 25-mLvolumetric flask,dilute with Diluentto volume,and mix.
Chromatographic system (see Chromatography á621ñ)
The liquid chromatograph is equipped with a 254-nm detector and a 3.9-mm ×15-cm column that contains 5-µm packing L1.The flow rate is about 1mLper minute.Chromatograph the Resolution solution,and record the peak responses as directed for Procedure:the relative retention times are about 0.4for methylparaben,0.7for propylparaben,and 1.0for yohimbine;and the resolution,R,between methylparaben and propylparaben and between propylparaben and yohimbine is not less than 2.0.Chromatograph the Standard preparation,and record the peak responses as directed for Procedure:the relative standard deviation for replicate injections is not more than 2.0%.
Separately inject equal volumes (about 25µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the areas for the major peaks.Calculate the quantity,in mg,of yohimbine (C21H26N2O3)in each mLof the Injection taken by the formula:
in which 354.45and 390.91are the molecular weights of yohimbine and yohimbine hydrochloride,respectively;Cis the concentration,in mg per mL,of USP Yohimbine Hydrochloride RSin the Standard preparation;Vis the volume,in mL,of Injection taken to prepare the Assay preparation;and rUand rSare the yohimbine peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
Pharmacopeial Forum:Volume No.27(2)Page 2219
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