Pyridostigmine Bromide Injection
»Pyridostigmine Bromide Injection is a sterile solution of Pyridostigmine Bromide in a suitable medium.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C9H13BrN2O2.
Packaging and storage— Preserve in single-dose containers,preferably of Type Iglass,protected from light.
Identification—
A: The solution prepared for measurement of absorbance in the Assayexhibits maxima and minima at the same wavelengths as that of a similar solution of USP Pyridostigmine Bromide RS,concomitantly measured.
B: To 2mLof Injection add 1mLof 2Nnitric acid:the solution so obtained responds to the tests for Bromide á191ñ.
Bacterial endotoxins á85ñ— It contains not more than 17.0USP Endotoxin Units per mg of pyridostigmine bromide.
pHá791ñ: between 4.5and 5.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Transfer to a suitable separator an accurately measured volume of Injection,equivalent to about 20mg of pyridostigmine bromide.Add 10mLof 1Nhydrochloric acid,and mix.Extract with four 20-mLportions and one 15-mLportion of ethyl ether,and discard the extracts.Transfer the aqueous layer to a 100-mLvolumetric flask,using about 25mLof water to aid the transfer.Place the flask on a steam bath and warm,with the aid of a stream of nitrogen,to evaporate any residual ether,then cool the flask to room temperature,dilute with water to volume,and mix.Dilute 20.0mLof the resulting solution with 0.1Nhydrochloric acid to 100.0mL,and mix.Dissolve an accurately weighed quantity of USP Pyridostigmine Bromide RSin 0.1Nhydrochloric acid to obtain a Standard solution having a known concentration of about 40µg per mL.Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 269nm,with a suitable spectrophotometer,using 0.1Nhydrochloric acid as the blank.Calculate the quantity,in mg,of C9H13BrN2O2in each mLof the Injection taken by the formula:
(0.5C/V)(AU/AS),
in which Cis the concentration,in µg per mL,of USP Pyridostigmine Bromide RSin the Standard solution,Vis the volume,in mL,of Injection taken,and AUand ASare the absorbances of the solution from the Injection and the Standard solution,respectively.
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1682
Phone Number:1-301-816-8330