Cyanocobalamin Co 57Oral Solution, chemical structure, molecular formula, Reference Standards

Cyanocobalamin Co 57Oral Solution

Vitamin B12-57Co.
Vitamin B12-57Co [41559-38-0;13115-03-2].

»Cyanocobalamin Co 57Oral Solution is a solution suitable for oral administration,containing Cyanocobalamin in which a portion of the molecules contain radioactive cobalt (57Co)in the molecular structure.Cyanocobalamin Co 57Oral Solution contains not less than 90.0percent and not more than 110.0percent of the labeled amount of 57Co as cyanocobalamin expressed in megabecquerels (microcuries)per mLat the time indicated in the labeling.The cyanocobalamin content is not less than 90.0percent and not more than 110.0percent of the labeled amount.Cyanocobalamin Co 57Oral Solution contains a suitable antimicrobial agent.

Specific activity: not less than 0.02MBq (0.5µCi)per µg of cyanocobalamin.

Packaging and storage— Preserve in tight containers,protected from light,and store in a cold place.

Labeling— Label it to include the following:the date of calibration;the amount of 57Co as cyanocobalamin expressed as total megabecquerels (microcuries)and as megabecquerels (microcuries)per mLat the time of calibration;the amount of cyanocobalamin expressed in µg per mL;the name and quantity of the added preservative;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 57Co is 270.9days,and directs that the Oral Solution be protected from light.

USP Reference standards á11ñ— USP Cyanocobalamin RS.

Radionuclide identification (see Radioactivity á821ñ)— Its gamma-ray spectrum is identical to that of a specimen of 57Co of known purity that exhibits a major photopeak having an energy of 0.122MeV.

Uniformity of dosage units á905ñ—

FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS:

meets the requirements.

Deliverable volume á698ñ—

FOR ORAL SOLUTION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.

pHá791ñ: between 4.0and 5.5.

Radiochemical purity—

Mobile phase— Prepare a solution of 10.0g of dibasic sodium phosphate in 1000mLof water,and adjust with phosphoric acid to a pHof 3.5.Prepare a mixture of this solution and methanol (73.5:26.5),mix,and degas.Use within 2days.

Test solution— Use the Oral Solution.

Standard solution— Transfer about 10mg of cyanocobalamin,accurately weighed,to a 100-mLvolumetric flask,dilute with Mobile phase to volume,and mix.Transfer 2.0mLof this solution to a 100-mLvolumetric flask,dilute with Mobile phase to volume,and mix.

Chromatographic system (see Chromatography á621ñ)— The liquid chromatograph is equipped with a 361-nm detector,a gamma detector adjusted for 57Co and a 4.6-mm ×25-cm stainless steel column that contains 5-µm packing L7.The flow rate is about 1mLper minute.

Procedure— Inject about 100µLof the Standard solution into the chromatograph,record the chromatogram for 30minutes,and note the retention time of the cyanocobalamin peak.Inject 100µLof the Test solution into the chromatograph,and record the chromatogram for three times the retention time of cyanocobalamin.Measure the peak areas using the gamma detector,and calculate the percentage of cyanocobalamin present as cyanocobalamin 57Co in the portion of Oral Solution taken by the formula:

100(rU/rT),

in which rUis the peak response for cyanocobalamin 57Co obtained from the Test solution;and rTis the total of all the peak area responses in the radiochromatogram obtained from the Test solution.Not less than 90%of the total radioactivity is found as cyanocobalamin 57Co.

Radionuclidic purity— Using a suitable calibrated instrument (see Radioactivity á821ñ)and standardized solutions of 58Co,57Co,and 60Co,record the gamma spectrum of the Oral Solution.The spectrum does not differ significantly from that of the standardized 57Co solution.Determine the relative amounts of 58Co,57Co,and 60Co present.Cobalt 58has a half-life of 70.9days,and its presence is shown by 0.511-MeVand 0.811-MeVgamma photons.Cobalt 60has a half-life of 5.27years,and its presence is shown by 1.173-MeVand 1.333-MeVgamma photons.Not more than 1%of the total radioactivity is due to 60Co;and not more than 2%of the total radioactivity is due to 58Co,60Co,and other radionuclidic impurities.

Content of cyanocobalamin— Determine the content,in µg per mL,of cyanocobalamin as directed under Vitamin B12Activity Assay á171ñ.

Assay for radioactivity— Using a suitable counting assembly (see Selection of a Counting Assemblyunder Radioactivity á821ñ),determine the radioactivity,in MBq (µCi)per mL,of Oral Solution by use of a calibrated system as directed under Radioactivity á821ñ.

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

Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents

USP28–NF23Page 529

Pharmacopeial Forum:Volume No.29(6)Page 1862

Phone Number:1-301-816-8305