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 95.0 percent and not more than 105.0 percent 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 I or Type II glass.
USP Reference standards 11
USP Endotoxin RS
A: Place in a separator a volume of Injection equivalent to about 300 mg of lidocaine hydrochloride, add 2 mL of 2 N sodium hydroxide, and extract with four 15-mL portions 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 24 hours: the residue so obtained responds to Identification test A under Lidocaine.
B: It responds to the Identification test under Dextrose.
Bacterial endotoxins 85 It contains not more than 1.1 USP Endotoxin Units per mg of lidocaine hydrochloride.
pH 791: between 3.0 and 7.0.
Other requirements It meets the requirements under Injections 1.
Assay for lidocaine hydrochloride Proceed with Injection as directed in the Assay for lidocaine hydrochloride under Lidocaine and Epinephrine Injection.
Assay for dextrose Determine the angular rotation of Injection in a suitable polarimeter tube (see Optical Rotation 781). Calculate the percentage (g per 100 mL) of dextrose (C6H12O6·H2O) in the portion of Injection taken by the formula:
(100/52.9)(198.17/180.16)ARin which 100 is the percentage; 52.9 is the midpoint of the specific rotation range for anhydrous dextrose, in degrees; 198.17 and 180.16 are the molecular weights for dextrose monohydrate and anhydrous dextrose, respectively; A is 100 mm divided by the length of the polarimeter tube, in mm; and R is the observed rotation, in degrees.
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USP35NF30 Page 3685Pharmacopeial Forum: Volume No. 30(5) Page 1631