» Dimercaprol Injection is a sterile solution of Dimercaprol in a mixture of Benzyl Benzoate and vegetable oil. It contains, in each 100 g, not less than 9.0 g and not more than 11.0 g of dimercaprol (C3H8OS2).
Packaging and storage Preserve in single-dose or multiple-dose containers, preferably of Type I or Type III glass.
Bacterial endotoxins 85 It contains not more than 1 USP Endotoxin Unit per mg of dimercaprol.
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 impurities under Dimercaprol.
Procedure Place about 1 g of Injection, accurately weighed and demonstrated to be free from hydrogen sulfide as directed in the Assay under Dimercaprol, in a 5-mL beaker, add 2 mL of 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-mL portions of Solvent hexane-diisopropyl ether mixture, and allow the washings to fall to the level of the Adsorbent. Proceed as directed for Procedure in the test for Limit of 1,2,3-trimercaptopropane and related impurities under 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 1, except that at times it may be turbid or contain small amounts of flocculent material.
Assay Transfer about 2 mL of Injection to a tared conical flask, and weigh accurately. Add 100 mL of a mixture of 1 volume of chloroform and 3 volumes of methanol, agitate to dissolve the Injection, and titrate with 0.1 N iodine VS to the production of a permanent yellow color. Perform a blank determination, and make any necessary correction. Calculate the percentage of dimercaprol (C3H8OS2) in the portion of Injection taken by the formula:
0.6211(V/W v / w)in which V is the volume, in mL, of 0.1 N iodine used; W is the weight, in g, of Injection taken; and v and w are the volume, in mL, of 0.1 N iodine and the weight, in g, of Injection, respectively, used in the test for Limit of 1,2,3-trimercaptopropane and related impurities.
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USP32NF27 Page 2168Pharmacopeial Forum: Volume No. 30(6) Page 1987