Pralidoxime Chloride for Injection
»Pralidoxime Chloride for Injection contains not less than 90.0percent and not more than 110.0percent of the labeled amount of pralidoxime chloride (C7H9ClN2O).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Completeness of solution á641ñ— The contents of 1container dissolve in 10mLof water to yield a clear solution.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Bacterial endotoxins á85ñ— It contains not more than 0.10USP Endotoxin Unit per mg of pralidoxime chloride.
pHá791ñ: between 3.5and 4.5,in a solution (1in 20).
Other requirements— It conforms to the Definition,responds to the Identificationtests,and meets the requirements for Loss on dryingand Heavy metalsunder Pralidoxime Chloride.It meets also the requirements for Sterility Tests á71ñ,Uniformity of Dosage Units á905ñ,and Labelingunder Injections á1ñ.
Assay—
Dilute phosphoric acid solution,Tetraethylammonium chloride solution,Mobile phase,Standard preparation,System suitability preparation,and Chromatographic system— Proceed as directed in the Assayunder 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 10g of pralidoxime chloride.Dissolve the contents of each container in water,and combine all of the solutions in a 1000-mLvolumetric flask.Rinse each container with water,and add the rinsings to the volumetric flask.Dilute with water to volume,and mix.Transfer 25.0mLof the resulting solution to a 200-mLvolumetric flask,dilute with water to volume,and mix.Transfer 2.0mLof this solution to a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder 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 Nis 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:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 1603
Phone Number:1-301-816-8251