1770 Adenosine / Official Monographs USP 34

solution having a known concentration of about 0.03 mg per tion. Vent the gas with a barely audible flow against a stainlessmL. If sodium chloride is present in the Injection, add 0.01 mL steel mirror for a few seconds: no liquid is discernible on theof sodium chloride solution (0.9 in 100) per mL of the antici- mirror.pated final volume of the Standard preparation before the addi- OdorCarefully open the container valve to produce a moder-tion of the warm water. ate flow of gas. Do not direct the gas stream toward the face,

System sensitivity solutionPipet 3.0 mL of the Standard prep- but deflect a portion of the stream toward the nose: no appre-aration into a 200-mL volumetric flask, dilute with water to vol- ciable odor is discernible.ume, and mix. Carbon dioxidePass 1000 50 mL through a carbon diox-

Assay preparationTransfer an accurately measured volume ide detector tube at the rate specified for the tube: the indica-of Injection, equivalent to about 30 mg of adenosine, to a 100- tor change corresponds to not more than 0.05%.mL volumetric flask, dilute with water to volume, and mix. Re- Carbon monoxidePass 1000 50 mL through a carbonserve a portion of this stock solution for use in the test for monoxide detector tube at the rate specified for the tube: theChromatographic purity. Pipet 5.0 mL of the stock solution into a indicator change corresponds to not more than 0.001%.50-mL volumetric flask, dilute with water to volume, and mix. Limit of nitric oxide and nitrogen dioxidePass 550 50

Chromatographic system (see Chromatography 621)The mL through a nitric oxidenitrogen dioxide detector tube at theliquid chromatograph is equipped with a 254-nm detector and rate specified for the tube: the indicator change corresponds toa 3.9-mm 30-cm column that contains packing L1. The flow not more than 2.5 ppm.rate is about 2.5 mL per minute. Chromatograph the System Sulfur dioxidePass 1050 50 mL through a sulfur dioxidesuitability solution, and record the peak responses as directed for detector tube at the rate specified for the tube: the indicatorProcedure: the tailing factor for the adenosine peak is not more change corresponds to not more than 5 ppm.than 2.0; and the resolution, R, between adenosine and inosine

AssayDetermine the oxygen concentration of Medical Air us-is not less than 6.0. Similarly chromatograph the Standard prep-ing an electrochemical cell analyzer readable to 0.1% of oxygenaration: the relative standard deviation for replicate injections isand calibrated with ambient air to an accuracy of 0.2% ofnot more than 1.5%. Chromatograph the System sensitivity solu-oxygen. [NOTEThe instrument utilizes the variations of electriction, and adjust the run time to 21/2 times the retention time ofcurrent produced by the interaction of oxygen with an electro-adenosine.chemical cell to display the oxygen strength of a confined sam-ProcedureSeparately inject equal volumes (about 10 L) of ple or an in-line flow of the gas. This current generates a signalthe Assay preparation and the Standard preparation into the proportional to the oxygen concentration, which is displayedchromatograph, record the chromatograms, and measure the on a meter.]areas of the adenosine peak responses. Calculate the quantity,

in mg, of adenosine (C10H13N5O4) in each mL of the Injectiontaken by the formula:

.

CD(rU /rS) Alaninein which C is the concentration, in mg per mL, of USP Adeno-sine RS in the Standard preparation; D is the concentration, inmg per mL, of adenosine in the Assay preparation, based on thelabeled quantity per mL and the extent of dilution; and rU and

rS are the peak responses for adenosine obtained from the Assaypreparation and the Standard preparation, respectively.

C3H7NO2 89.09L-Alanine [56-41-7].

. DEFINITIONAlanine contains NLT 98.5% and NMT 101.5% of C3H7NO2, asMedical Air

L-alanine, calculated on the dried basis.

Medical Air is a natural or synthetic mixture of IDENTIFICATIONgases consisting largely of nitrogen and oxygen. INFRARED ABSORPTION 197KIt contains not less than 19.5 percent and not

ASSAYmore than 23.5 percent, by volume, of O2. PROCEDURESample: 80 mg of AlaninePackaging and storagePreserve in cylinders or in a lowTitrimetric systempressure collecting tank. Containers used for Medical Air are not(See Titrimetry 541.)to be treated with any toxic, sleep-inducing, or narcosis-produc-Mode: Direct titrationing compounds, and are not to be treated with any compoundTitrant: 0.1 N perchloric acid VSthat would be irritating to the respiratory tract when the Medi-Endpoint detection: Potentiometriccal Air is used.Blank: 3 mL of formic acid in 50 mL of glacial acetic acidNOTEReduce the container pressure by means of a regula-

Analysis: Dissolve the Sample in a mixture of 3 mL of formictor. Measure the gases with a gas volume meter downstreamacid and 50 mL of glacial acetic acid, and titrate with 0.1 Nfrom the detector tube in order to minimize contamination orperchloric acid VS. Calculate the percentage of C3H7NO2 inchange of the specimens.the portion taken:The various detector tubes called for in the respective tests are

listed under Reagent Specifications in the section Reagents, In- Result = [(V B) N F 100]/Wdicators, and Solutions.LabelingWhere it is piped directly from the collecting tank V = Sample titrant volume (mL)to the point of use, label each outlet Medical Air. B = Blank titrant volume (mL)Water and oilSupport 1 container in an inverted position N = titrant normality (mEq/mL)(with the valve at the bottom) for 5 minutes. Cautiously open F = equivalency factor: 89.09 mg/mEqthe valve slightly, maintaining the container in an inverted posi- W = weight of the Sample (mg)

Official from December 1, 2011Copyright (c) 2012 The United States Pharmacopeial Convention. All rights reserved.

Accessed from 190.216.198.50 by JNJconsumer on Wed Mar 14 12:09:52 EDT 2012