Strontium Chloride Sr 89Injection, chemical structure, molecular formula, Reference Standards

Strontium Chloride Sr 89Injection

89SrC12 159.9

Strontium chloride (89SrCl2) [38270-90-5].

»Strontium Chloride Sr 89Injection is a sterile solution of radioactive strontium (89Sr)processed in the form of strontium chloride in Water for Injection.

Strontium Chloride Sr 89Injection contains not less than 90.0percent and not more than 110.0percent of the labeled amount of 89Sr as strontium chloride expressed in megabecquerels per mL(or in millicuries per mL)at the time indicated in the labeling.The strontium chloride content is not less than 90.0percent and not more than 110.0percent of the labeled amount.

Specific activity: not less than 2.96MBq (80µCi)per mg of strontium at the time indicated in the labeling.

Packaging and storage— Preserve in single-dose containers that are adequately shielded.

Labeling— Label it to include the following,in addition to the information specified for Labelingunder Injections á1ñ:the time and date of calibration;the amount of strontium chloride expressed as mg of strontium per mL;the amount of 89Sr as labeled strontium chloride expressed as total megabecquerels (or millicuries)and concentration as megabecquerels per mL(or millicuries per mL)on the date and time of calibration;the expiration date;and the statement “Caution—Radioactive Material.”The labeling indicates that in making dosage calculations,correction is to be made for radioactive decay,and also indicates that the radioactive half-life of 89Sr is 50.5days.

USP Reference standards á11ñ— USP Endotoxin RS.

Radionuclide identification (see Radioactivity á821ñ)— Strontium 89decays by beta emission to stable Yttrium 89with 0.01%of disintegrations going via the metastable daughter 89mYwith a half-life of 16seconds,with which it rapidly establishes radioactive equilibrium.Its gamma-ray spectrum is identical to that of a specimen of strontium 89in equilibrium with 89mYexhibiting bremsstrahlung and a gamma photopeak of 0.909MeV.[NOTE—Use a plastic container to perform measurements.]

Bacterial endotoxins á85ñ— It meets the requirements,the limit of endotoxin content being not more than 175/VUSP Endotoxin Unit per mLof the Injection,when compared with the USP Endotoxin RS,in which Vis the maximum recommended total dose,in mL,at the expiration date or time.

pHá791ñ: between 4.0and 7.5.

Radionuclidic purity— [NOTE—Use a plastic container to perform the following test.]Using a suitable counting assembly (see Assay,Gamma-Emitting Radionuclides,under Radioactivity á821ñ),determine the radioactivity of each gamma-emitting radionuclidic impurity,in kBq per MBq (or µCi per mCi)of 89Sr,in the Injection by use of a calibrated system as directed under Radioactivity á821ñ.The total activity of all gamma-emitting impurities is not greater than 370kBq per 37MBq (or 10µCi per mCi)of 89Sr at the expiration date stated in the labeling.

Chemical purity (Limit of aluminum)— [NOTE—The Standard preparations and the Test preparation may be modified,if necessary,to obtain solutions of suitable concentrations adaptable to the linear or working range of the instrument.]

Nitric acid diluent— Dilute 40mLof nitric acid with water to 1000mL.

Standard preparations— Transfer 2000mg of aluminum metal to a 1000-mLvolumetric flask,add 50mLof 6Nhydrochloric acid,swirl to ensure contact of the aluminum and the acid,and allow the reaction to proceed until all of the aluminum has dissolved.Dilute with water to volume,and mix.Transfer 5.0mLof this solution to a 1000-mLvolumetric flask,dilute with water to volume,and mix.Transfer 10.0mLof this solution to a 100-mLvolumetric flask,dilute with Nitric acid diluentto volume,and mix.Transfer 1.0-,2.0-,and 4.0-mLportions of this solution to separate 100-mLvolumetric flasks,dilute with Nitric acid diluentto volume,and mix.These solutions contain 0.01,0.02,and 0.04µg of Al per mL,respectively.

Test preparation— Transfer 1.0mLof Injection to a 100-mLvolumetric flask,and carefully add 4mLof nitric acid.Dilute with water to volume,and mix.

Procedure— Determine the absorbances of the Standard preparationsand the Test preparationat the aluminum emission line at 309.3nm with an atomic absorption spectrophotometer (see Spectrophotometry and Light-Scattering á851ñ)equipped with an aluminum hollow-cathode lamp and a flameless electrically heated furnace,using Nitric acid diluentas the blank.Plot the absorbances of the Standard preparationsversus the contents of Al,in µg per mL,drawing the straight line best fitting the three points.From the graph so obtained,determine the quantity,in µg,of Al in each mLof the Test preparation.Calculate the quantity,in µg per g,of Al in the specimen taken by multiplying this value by 100:the limit is 2µg per g.

Assay for radioactivity— Using a suitable counting assembly (see Assay,Gamma-Emitting Radionuclides,under Radioactivity á821ñ),determine the radioactivity,in MBq (or mCi)per mL,of the Injection by use of a calibrated system as directed under Radioactivity á821ñ.

Other requirements— It meets the requirements under Injections á1ñ,except that it is not subject to the recommendation on Volume in Container.

Assay—

Potassium chloride solution— Dissolve 1.9g of potassium chloride in water,dilute with water to 1000mL,and mix.This solution contains 1000µg of potassium per mL.

Strontium stock solution— Transfer 1.685g of strontium carbonate,accurately weighed,to a 100-mLvolumetric flask,and add water to dissolve.Add 10mLof hydrochloric acid,dilute with water to volume,and mix to obtain a solution containing 10,000µg of strontium per mL.

Standard preparations— Pipet 10mLof Strontium stock solutioninto a 100-mLvolumetric flask.Add 10mLof hydrochloric acid,dilute with Potassium chloride solutionto volume,and mix.Transfer 10mLand 20mL,respectively,of this solution into separate 100-mLvolumetric flasks,dilute with Potassium chloride solutionto volume,and mix.These Standard preparationscontain 100and 200µg of strontium per mL.

Assay preparation— Pipet 0.1mLof Injection into a small beaker.Add 5mLof Potassium chloride solution,and mix.

Procedure— Concomitantly determine the absorbances of the Standard preparationsand the Assay preparationat the strontium emission line of 407.8nm with an atomic absorption spectrophotometer (see Spectrophotometry and Light-Scattering á851ñ)equipped with a strontium hollow-cathode lamp and a nitrous oxide–acetylene flame,using Potassium chloride solutionas the blank.Plot the absorbances of the Standard preparationsversus concentration,in µg per mL,of strontium,and draw the straight line best fitting the four plotted points.From the graph so obtained,determine the concentration,in µg per mL,of strontium in the Assay preparation.Calculate the quantity,in µg,of strontium in each mLof the Injection taken by the formula:

51C,

in which Cis the concentration,in µg per mL,of strontium in the Assay preparation.

Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate

Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents

USP28–NF23Page 1806

Phone Number:1-301-816-8305