Mechlorethamine Hydrochloride
(me'' klor eth' a meen hye'' droe klor' ide).
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192.51Ethanamine, 2-chloro-N-(2-chloroethyl)-N-methyl-, hydrochloride.
2,2¢-Dichloro-N-methyldiethylamine hydrochloride
[55-86-7].» Mechlorethamine Hydrochloride contains not less than 97.5 percent and not more than 100.5 percent of C5H11Cl2N·HCl, calculated on the anhydrous basis.
Packaging and storage—
Preserve in tight, light-resistant containers.
Labeling—
The label bears a warning that great care should be taken to prevent inhaling particles of Mechlorethamine Hydrochloride and exposing the skin to it.
USP Reference standards 
11
—
11—
USP Mechlorethamine Hydrochloride RS 
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Identification—
B:
Transfer 100 mg to a test tube containing 1 mL of sodium thiosulfate solution (prepared by dissolving 1 g of sodium thiosulfate and 100 mg of sodium carbonate in 40 mL of water), shake, allow to stand for 2 hours, then add 1 drop of iodine TS: the color of free iodine remains.
Melting range 741:
between 108
and 111.
741:
between 108 and 111.
pH 791:
between 3.0 and 5.0, in a solution (1 in 500).
791:
between 3.0 and 5.0, in a solution (1 in 500).
Water, Method I 921:
not more than 0.4%.
921:
not more than 0.4%.
Ionic chloride content—
Dissolve about 30 mg, accurately weighed, in 30 mL of water contained in a beaker. Add 5 mL of nitric acid and stir. Titrate with 0.02 N silver nitrate VS to a potentiometric endpoint, using a silver combination electrode. Perform a blank determination (see Titrimetry 541), and make any necessary correction. Each mL of 0.02 N silver nitrate is equivalent to 0.709 mg of ionic chloride: not less than 18.0% and not more than 19.3% of ionic chloride is found.
541), and make any necessary correction. Each mL of 0.02 N silver nitrate is equivalent to 0.709 mg of ionic chloride: not less than 18.0% and not more than 19.3% of ionic chloride is found.
Assay—
Transfer about 100 mg of Mechlorethamine Hydrochloride, accurately weighed, to a 125-mL conical flask. Add 100 mg of sodium bicarbonate and 20.0 mL of 0.1 N sodium thiosulfate VS. Allow to stand for 2½ hours, add 3 mL of starch TS, and titrate the excess sodium thiosulfate with 0.1 N iodine VS. Each mL of 0.1 N sodium thiosulfate is equivalent to 9.626 mg of C5H11Cl2N·HCl.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Feiwen Mao, M.S.
Senior Scientific Liaison 1-301-816-8320 |
(SM32010) Monographs - Small Molecules 3 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 3775
Pharmacopeial Forum: Volume No. 29(3) Page 636