U.S. PHARMACOPEIA

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Mechlorethamine Hydrochloride for Injection
» Mechlorethamine Hydrochloride for Injection is a sterile mixture of Mechlorethamine Hydrochloride with Sodium Chloride or other suitable diluent. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of mechlorethamine hydrochloride (C5H11Cl2N·HCl).
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.
Labeling— It meets the requirements for Labeling under Injections 1. The label bears a warning that great care should be taken to prevent inhaling particles of Mechlorethamine Hydrochloride for Injection and exposing the skin to it.
Completeness of solution 641— A 0.10-g portion dissolves in 10 mL of carbon dioxide-free water to yield a clear solution.
Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Identification— It meets the requirements of the Identification tests under Mechlorethamine Hydrochloride.
Bacterial endotoxins 85— It contains not more than 12.5 USP Endotoxin Units per mg of mechlorethamine hydrochloride.
pH 791: between 3.0 and 5.0, in a solution (1 in 50).
Water, Method I 921: not more than 1.0%.
Particulate matter 788: meets the requirements for small-volume injections.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements for Sterility Tests 71 and Uniformity of Dosage Units 905.
Assay—
Assay preparation— Select a counted number of not fewer than 10 containers of Mechlorethamine Hydrochloride for Injection, equivalent to about 100 mg of mechlorethamine hydrochloride. Dissolve the contents of each container in water, and transfer the resulting solutions to a 250-mL conical flask.
Procedure— Immediately proceed as directed in the Assay under Mechlorethamine Hydrochloride, beginning with “Add 100 mg of sodium bicarbonate.” Calculate the average content, in mg, of mechlorethamine hydrochloride (C5H11Cl2N·HCl) per container of Mechlorethamine Hydrochloride for Injection taken by the formula:
9.626(V / N),
in which V is the volume, in mL, of 0.1 N sodium thiosulfate consumed; and N is the number of containers selected to prepare the Assay preparation.
Auxiliary Information— Staff Liaison : Feiwen Mao, M.S., Senior Scientific Associate
Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
USP29–NF24 Page 1321
Phone Number : 1-301-816-8320