Lidocaine Hydrochloride and Dextrose Injection
»Lidocaine Hydrochloride and Dextrose Injection is a sterile solution of Lidocaine Hydrochloride and Dextrose in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amounts of lidocaine hydrochloride (C14H22N2O·HCl)and dextrose (C6H12O6·H2O).
Packaging and storage— Preserve in single-dose glass or plastic containers.Glass containers are preferably of Type Iof Type IIglass.
Identification—
A: Place in a separator a volume of Injection equivalent to about 300mg of lidocaine hydrochloride,add 2mLof 2Nsodium hydroxide,and extract with four 15-mLportions of chloroform.Combine the chloroform extracts,and evaporate with the aid of a current of warm air to dryness.Dissolve the crystals so obtained in solvent hexane,evaporate with the aid of warm air,and dry the residue in vacuum over silica gel for 24hours:the residue so obtained responds to Identificationtest Aunder Lidocaine.
B: It responds to the Identificationtest under Dextrose.
Bacterial endotoxins á85ñ— It contains not more than 1.1USP Endotoxin Units per mg of lidocaine hydrochloride.
pHá791ñ: between 3.0and 7.0.
Other requirements— It meets the requirements under Injections á1ñ.
Assay for lidocaine hydrochloride— Proceed with Injection as directed in the Assay for lidocaine hydrochlorideunder Lidocaine and Epinephrine Injection.
Assay for dextrose— Determine the angular rotation of Injection in a suitable polarimeter tube at 25(see Optical Rotation á781ñ).The observed rotation in degrees,multiplied by 1.0425A,in which Ais the ratio 200divided by the length,in mm,of the polarimeter tube employed,represents the weight,in g,of C6H12O6·H2Oin 100mLof the Injection.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1132
Pharmacopeial Forum:Volume No.30(5)Page 1631
Phone Number:1-301-816-8379