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 90.0percent and not more than 110.0percent of the labeled amount of mechlorethamine hydrochloride (C5H11Cl2N·HCl).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Labeling— It meets the requirements for Labelingunder Injections á1ñ.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 á641ñ— A0.10-g portion dissolves in 10mLof carbon dioxide-free water to yield a clear solution.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Identification— It meets the requirements of the Identificationtests under Mechlorethamine Hydrochloride.
Bacterial endotoxins á85ñ— It contains not more than 12.5USP Endotoxin Units per mg of mechlorethamine hydrochloride.
pHá791ñ: between 3.0and 5.0,in a solution (1in 50).
Water,Method Iá921ñ: not more than 1.0%.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements for Sterility Tests á71ñand Uniformity of Dosage Units á905ñ.
Assay—
Assay preparation— Select a counted number of not fewer than 10containers of Mechlorethamine Hydrochloride for Injection,equivalent to about 100mg of mechlorethamine hydrochloride.Dissolve the contents of each container in water,and transfer the resulting solutions to a 250-mLconical flask.
Procedure— Immediately proceed as directed in the Assayunder Mechlorethamine Hydrochloride,beginning with “Add 100mg 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 Vis the volume,in mL,of 0.1Nsodium thiosulfate consumed;and Nis the number of containers selected to prepare the Assay preparation.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 1193
Phone Number:1-301-816-8389