Procaine Hydrochloride Injection
»Procaine Hydrochloride Injection is a sterile solution of Procaine Hydrochloride in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of C13H20N2O2·HCl.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Ior Type IIglass.The Injection may be packaged in 100-mLmultiple-dose containers.
Identification— Evaporate a portion of Injection,equivalent to about 20mg of procaine hydrochloride,on a steam bath just to dryness,and dry over silica gel for 18hours:the residue responds to Identificationtests Aand Bunder Procaine Hydrochloride.
Bacterial endotoxins á85ñ It contains not more than 0.6USP Endotoxin Unit per mg of procaine hydrochloride.
pHá791ñ: between 3.0and 5.5.
Particulate matter á788ñ: meets the requirements under Small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Standard preparation— Transfer to a 125-mLseparator about 50mg,accurately weighed,of USP Procaine Hydrochloride RS,and dilute with water to 20mL.
Assay preparation— Transfer to a 125-mLseparator an accurately measured volume of Injection,equivalent to about 50mg of procaine hydrochloride,and dilute with water to 20mL.
Procedure— To the Standard preparationand also to the Assay preparationadd 5mLof 6Nammonium hydroxide,then treat each as follows.Extract with five 25-mLportions of chloroform,and filter the combined extracts through about 1g of anhydrous sodium sulfate supported on a pledget of glass wool.Receive the filtrate in a 200-mLvolumetric flask,add chloroform to volume,and mix.Transfer 3.0mLof this solution to a 100-mLvolumetric flask,add chloroform to volume,and mix.Concomitantly determine the absorbances of both solutions at the wavelength of maximum absorbance at about 280nm,with a suitable spectrophotometer,using chloroform as the blank.Calculate the quantity,in mg,of C13H20N2O2·HCl in each mLof the Injection taken by the formula:
(W/V)(AU/AS),
in which Wis the weight,in mg,of USP Procaine Hydrochloride RSused,Vis the volume,in mL,of Injection taken,and AUand ASare the absorbances of the solutions from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1628
Phone Number:1-301-816-8379