Chloroprocaine Hydrochloride Injection
»Chloroprocaine Hydrochloride Injection is a sterile solution of Chloroprocaine Hydrochloride in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of chloroprocaine hydrochloride (C13H19ClN2O2·HCl).
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass.
Identification— Dissolve 60mg of USP Chloroprocaine Hydrochloride RSin 10mLof water in a 60-mLseparator,and in a second 60-mLseparator mix a volume of Injection,equivalent to 60mg of chloroprocaine hydrochloride,with sufficient water to obtain 10mLof solution.Add 5mLof dilute ammonium hydroxide (4in 10)to each,mix,and immediately extract each with four 10-mLportions of chloroform,passing the extracts from the Reference Standard and the test specimen through cotton filters into separate 50-mLvolumetric flasks.Dilute each with chloroform to volume,and mix.Add a mixture of chloroform and methanol (4:1)to a suitable chromatographic chamber arranged for thin-layer chromatography (see Chromatography á621ñ),cover the chamber,and allow the system to equilibrate for 15minutes.Apply separately 10-µLportions of the chloroform solutions obtained from the Reference Standard and the test specimen to a suitable thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture.Allow the spots to dry,and develop the chromatogram until the solvent front has moved about three-fourths of the length of the plate.Remove the plate from the developing chamber,mark the solvent front,and allow the solvent to evaporate.Locate the spots on the plate by examination under short-wavelength UVlight:the RFvalue of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution (RFabout 0.40).After viewing,spray the chromatogram with iodoplatinate TS:violet-blue colored spots,characteristic of tertiary nitrogen compounds,are visible.
pHá791ñ: between 2.7and 4.0.
Related compounds—
4-Amino-2-chlorobenzoic acid— Using the chromatograms obtained as directed for the Assay,calculate the percentage of 4-amino-2-chlorobenzoic acid (C7H6ClNO2)in the chloroprocaine hydrochloride contained in the Injection taken by the formula:
10,000(C/Wa)(rU/rS),
in which Cis the concentration,in mg per mL,of 4-amino-2-chlorobenzoic acid in the Standard preparation;Wais the quantity,in mg,of chloroprocaine hydrochloride in the portion of Injection taken to prepare the Assay preparation,determined as directed in the Assay preparation;and rUand rSare the 4-amino-2-chlorobenzoic acid peak responses obtained from the Assay preparationand the Standard preparation,respectively:not more than 3.0%is found.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase,Standard 4-amino-2-chlorobenzoic acid solution,Standard preparation,System suitability solution,and Chromatographic system— Proceed as directed in the Assayunder Chloroprocaine Hydrochloride.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 100mg of chloroprocaine hydrochloride,to a 100-mLvolumetric flask,add 40mLof methanol,dilute with water to volume,and mix.
Procedure— Proceed as directed in the Assayunder Chloroprocaine HydrochlorideCalculate the quantity,in mg,of chloroprocaine hydrochloride (C13H19ClN2O2·HCl)in each mLof the Injection taken by the formula:
100(C/V)(rU/rS),
in which Vis the volume,in mL,of Injection taken,and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 443
Phone Number:1-301-816-8379