Chloroprocaine Hydrochloride Injection
» Chloroprocaine Hydrochloride Injection is a sterile solution of Chloroprocaine Hydrochloride in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of chloroprocaine hydrochloride (C13H19ClN2O2·HCl).
Packaging and storage Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
USP Reference standards 11
Identification Dissolve 60 mg of USP Chloroprocaine Hydrochloride RS in 10 mL of water in a 60-mL separator, and in a second 60-mL separator mix a volume of Injection, equivalent to 60 mg of chloroprocaine hydrochloride, with sufficient water to obtain 10 mL of solution. Add 5 mL of dilute ammonium hydroxide (4 in 10) to each, mix, and immediately extract each with four 10-mL portions of chloroform, passing the extracts from the Reference Standard and the test specimen through cotton filters into separate 50-mL volumetric 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 621), cover the chamber, and allow the system to equilibrate for 15 minutes. Apply separately 10-µL portions 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 UV light: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution (RF about 0.40). After viewing, spray the chromatogram with iodoplatinate TS: violet-blue colored spots, characteristic of tertiary nitrogen compounds, are visible.
pH 791: between 2.7 and 4.0.
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 C is the concentration, in mg per mL, of 4-amino-2-chlorobenzoic acid in the Standard preparation; Wa is 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 rU and rS are the 4-amino-2-chlorobenzoic acid peak responses obtained from the Assay preparation and the Standard preparation, respectively: not more than 3.0% is found.
Other requirements It meets the requirements under Injections 1.
Mobile phase, Standard 4-amino-2-chlorobenzoic acid solution, Standard preparation, System suitability solution, and Chromatographic system Proceed as directed in the Assay under Chloroprocaine Hydrochloride.
Assay preparation Transfer an accurately measured volume of Injection, equivalent to about 100 mg of chloroprocaine hydrochloride, to a 100-mL volumetric flask, add 40 mL of methanol, dilute with water to volume, and mix.
Procedure Proceed as directed in the Assay under Chloroprocaine Hydrochloride. Calculate the quantity, in mg, of chloroprocaine hydrochloride (C13H19ClN2O2·HCl) in each mL of the Injection taken by the formula:
100(C / V)(rU / rS)in which V is the volume, in mL, of Injection taken, and the other terms are as defined therein.
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USP35NF30 Page 2630