Propoxycaine and Procaine Hydrochlorides and Levonordefrin Injection
»Propoxycaine and Procaine Hydrochlorides and Levonordefrin Injection is a sterile solution of Propoxycaine Hydrochloride,Procaine Hydrochloride,and Levonordefrin in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of propoxycaine hydrochloride (C16H26N2O3·HCl),not less than 95.0percent and not more than 105.0percent of the labeled amount of procaine hydrochloride (C13H20N2O2·HCl),and not less than 90.0percent and not more than 110.0percent of the labeled amount of levonordefrin (C9H13NO3).
Packaging and storage— Preserve in single-dose containers,preferably of Type Iglass.
Labeling— The label indicates that the Injection is not to be used if its color is pinkish or darker than slightly yellow or if it contains a precipitate.
Color and clarity— Using the Injection as the Test solution,proceed as directed for Color and clarityunder Mepivacaine Hydrochloride and Levonordefrin Injection.
Identification—
A: Cool a mixture of 10mLof Injection and 10mLof 3Nhydrochloric acid in an ice bath to 0,add 5mLof sodium nitrite solution (1in 5),stirring gently,and 2mLof a solution of 0.1g of 2-naphthol in 5mLof 1Nsodium hydroxide,and observe immediately:a bright orange-red precipitate is formed (presence of a primary aminophenyl group).
B: It responds to the tests for Chloride á191ñ.
C: To about 25mLof Injection add 1drop of ferric chloride TS:the solution immediately turns a light green and changes to a light blue within 1minute.Add 2drops of 3Nhydrochloric acid:the color reverts to light green (presence of levonordefrin).
Bacterial endotoxins á85ñ— It contains not more than 0.8USP Endotoxin Unit per mg of propoxycaine hydrochloride.
pHá791ñ: between 3.5and 5.0.
Other requirements— It meets the requirements under Injections á1ñ.
Assay for propoxycaine and procaine hydrochlorides—
Standard propoxycaine hydrochloride preparation— Prepare,by quantitative and stepwise dilution,a solution in dilute hydrochloric acid (1in 6)containing about 50µg of USP Propoxycaine Hydrochloride RS,accurately weighed,in each mL.
Standard procaine hydrochloride preparation— Prepare,by quantitative and stepwise dilution,a solution in dilute hydrochloric acid (1in 6)containing about 200µg of USP Procaine Hydrochloride RS,accurately weighed,in each mL.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 100mg of procaine hydrochloride,to a 125-mLseparator containing 25mLof chloroform and 10mLof water.Add 5mLof sodium carbonate TS,shake vigorously,allow the layers to separate,and transfer the chloroform layer to a second separator.Extract the aqueous layer with two 10-mLportions of chloroform,adding the extracts to the second separator.Extract the combined chloroform extracts with 35mLof dilute hydrochloric acid (1in 6),transfer the chloroform to a third separator,and transfer the acid extract to a 100-mLvolumetric flask.Extract the chloroform with two 10-mLportions of dilute hydrochloric acid (1in 6),add the acid extracts to the volumetric flask,add dilute hydrochloric acid (1in 6)to volume,and mix.Transfer 15.0mLof this solution to a second 100-mLvolumetric flask,add dilute hydrochloric acid (1in 6)to volume,and mix.
Procedure— Concomitantly determine the absorbances of the Standard preparationsand the Assay preparationin 1-cm cells at 296and 272nm,with a suitable spectrophotometer,using water as the blank.Calculate the quantity,in mg,of propoxycaine hydrochloride (C16H26N2O3·HCl)in each mLof the Injection taken by the formula:
(0.667C/V)(A296A4-A272A3)/(A1A4-A2A3),
in which Cis the concentration,in µg per mL,of USP Propoxycaine Hydrochloride RSin the Standard propoxycaine hydrochloride preparation.
Calculate the quantity,in mg,of procaine hydrochloride (C13H20N2O2·HCl)in each mLof the Injection taken by the formula:
(0.667C/V)(A272A1-A296A2)/(A1A4-A2A3),
in which Cis the concentration,in µg per mL,of USP Procaine Hydrochloride RSin the Standard procaine hydrochloride preparation,Vis the volume,in mL,of Injection taken,A1and A2are the absorbances of the Standard propoxycaine hydrochloride preparationat 296and 272nm,respectively,A3and A4are the absorbances of the Standard procaine hydrochloride preparationat 296and 272nm,respectively,and A296and A272are the absorbances of the Assay preparationat 296and 272nm,respectively.
Assay for levonordefrin—
Ferro-citrate solution, Buffer solution,and Standard preparation—Prepare as directed under Epinephrine Assay á391ñ.
Assay preparation— Proceed with Injection as directed for Assay Preparationunder Epinephrine Assay á391ñ,except to read “levonordefrin”where “epinephrine”is specified.
Procedure— Proceed as directed for Procedureunder Epinephrine Assayá391ñ.Calculate the quantity,in mg,of levonordefrin (C9H13NO3)in each mLof the Injection taken by the formula:
(183.21/333.30)(0.05C/V)(AU/AS),
in which 183.21and 333.30are the molecular weights of levonordefrin and epinephrine bitartrate,respectively,Cis the concentration,in µg per mL,of USP Epinephrine Bitartrate RSin the Standard preparation,and Vis the volume,in mL,of Injection taken.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1649
Phone Number:1-301-816-8379