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Pralidoxime Chloride for Injection
» Pralidoxime Chloride for Injection contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of pralidoxime chloride (C7H9ClN2O).
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.
Completeness of solution 641— The contents of 1 container dissolve in 10 mL of water to yield a clear solution.
Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Bacterial endotoxins 85— It contains not more than 0.10 USP Endotoxin Unit per mg of pralidoxime chloride.
pH 791: between 3.5 and 4.5, in a solution (1 in 20).
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It conforms to the Definition, responds to the Identification tests, and meets the requirements for Loss on drying and Heavy metals under Pralidoxime Chloride. It meets also the requirements for Sterility Tests 71, Uniformity of Dosage Units 905, and Labeling under Injections 1.
Assay—
Dilute phosphoric acid solution, Tetraethylammonium chloride solution, Mobile phase, Standard preparation, System suitability preparation, and Chromatographic system— Proceed as directed in the Assay under Pralidoxime Chloride.
Assay preparation— Select an accurately counted number of containers of Pralidoxime Chloride for Injection, the combined contents of which are equivalent to about 10 g of pralidoxime chloride. Dissolve the contents of each container in water, and combine all of the solutions in a 1000-mL volumetric flask. Rinse each container with water, and add the rinsings to the volumetric flask. Dilute with water to volume, and mix. Transfer 25.0 mL of the resulting solution to a 200-mL volumetric flask, dilute with water to volume, and mix. Transfer 2.0 mL of this solution to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Pralidoxime Chloride. Calculate the quantity, in mg, of pralidoxime chloride (C7H9ClN2O) in each container of Pralidoxime Chloride for Injection taken by the formula:
400(C / N)(rU / rS),
in which N is the number of containers selected for the Assay preparation, and the other terms are as defined therein.
Auxiliary Information— Staff Liaison : Elena Gonikberg, Ph.D., Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29–NF24 Page 1781
Phone Number : 1-301-816-8251