Dimercaprol Injection
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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).
1 Packaging and storage
Preserve in single-dose or multiple-dose containers, preferably of Type I or Type III glass.
2 Bacterial Endotoxins Test 〈85〉
It contains not more than 1 USP Endotoxin Unit per mg of dimercaprol.
3 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.
4 Other requirements
It meets the requirements under Injections and Implanted Drug Products 〈1〉, except that at times it may be turbid or contain small amounts of flocculent material.
5 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.
