Dimercaprol Injection
»Dimercaprol Injection is a sterile solution of Dimercaprol in a mixture of Benzyl Benzoate and vegetable oil.It contains,in each 100g,not less than 9.0g and not more than 11.0g of C3H8OS2.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Ior Type IIIglass.
Limit of 1,2,3-trimercaptopropane and related impurities—
Adsorbent ,Standard buffer solution,Acid-washed solvent hexane,Diisopropyl ether,Solvent hexane-diisopropyl ether mixture,Chromatographic tube,and Chromatographic column—Prepare as directed in the test for Limit of 1,2,3-trimercaptopropane and related impuritiesunder Dimercaprol.
Procedure— Place about 1g of Injection,accurately weighed and demonstrated to be free from hydrogen sulfide as directed in the Assayunder Dimercaprol,in a 5-mLbeaker,add 2mLof Solvent hexane-diisopropyl ether mixture,and mix.Transfer the resulting solution to the prepared Chromatographic column.When the liquid has passed into the column,wash the beaker with two 2-mLportions of Solvent hexane-diisopropyl ether mixture,and allow the washings to fall to the level of the Adsorbent.Proceed as directed for Procedurein the test for Limit of 1,2,3-trimercaptopropane and related impuritiesunder Dimercaprol.The limit of 1,2,3-trimercaptopropane (C3H8S3)is not more than 4.5%,by weight,of the content of dimercaprol.
Other requirements— It meets the requirements under Injections á1ñ,except that at times it may be turbid or contain small amounts of flocculent material.
Assay— Transfer about 2mLof Injection to a tared conical flask,and weigh accurately.Add 100mLof a mixture of 1volume of chloroform and 3volumes of methanol,agitate to dissolve the Injection,and titrate with 0.1Niodine VSto the production of a permanent yellow color.Perform a blank determination,and make any necessary correction.Calculate the percentage of C3H8OS2taken by the formula:
0.6211(V/W-v/w),
in which Vis the volume,in mL,of 0.1Niodine used,Wis the weight,in g,of Injection taken,and vand ware the volume,in mL,of 0.1Niodine and the weight,in g,of Injection,respectively,used in the test for Limit of 1,2,3-trimercaptopropane and related impurities.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 662
Phone Number:1-301-816-8251