Ketamine Hydrochloride Injection
»Ketamine Hydrochloride Injection is a sterile solution of Ketamine Hydrochloride in Water for Injection.It contains an amount of ketamine hydrochloride (C13H16ClNO·HCl)equivalent to not less than 95.0percent and not more than 105.0percent of the labeled amount of ketamine (C13H16ClNO).
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass,protected from light and heat.
Identification—
A: The UVabsorption spectrum,measured in the region between 250and 350nm,of a dilution of Injection in 0.01Nmethanolic sodium hydroxide containing ketamine hydrochloride equivalent to about 800µg of ketamine per mL,exhibits maxima and minima at the same wavelengths as that of a similar preparation of USP Ketamine Hydrochloride RS,concomitantly measured.
B: The UVabsorption spectrum of the solution employed for measurement of absorbance of the assay solution,prepared as directed in the Assay,exhibits maxima and minima at the same wavelengths as that of the Standard solution,prepared as directed in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 0.4USP Endotoxin Unit per mg of ketamine hydrochloride.
pHá791ñ: between 3.5and 5.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Transfer an accurately measured volume of Injection,equivalent to about 500mg of ketamine hydrochloride,to a 200-mLvolumetric flask,dilute with water to volume,and mix.Transfer 20.0mLof this solution to a 125-mLseparator,add 3mLof 0.1Nsodium hydroxide,and extract with three 15-mLportions of chloroform.Collect the chloroform extracts in a second 125-mLseparator,and extract with three 30-mLportions of 0.1Nsulfuric acid,collecting the acid extracts in a 200-mLvolumetric flask.Dilute with 0.1Nsulfuric acid (saturated with chloroform)to volume,and mix.Concomitantly determine the absorbances of this solution and a Standard solution of USP Ketamine Hydrochloride RSin the same medium having a known concentration of about 250µg per mL,in 1-cm cells at the wavelength of maximum absorbance at about 269nm,with a suitable spectrophotometer,using 0.1Nsulfuric acid (saturated with chloroform)as the blank.Calculate the quantity,in mg,of ketamine (C13H16ClNO)in each mLof the Injection taken by the formula:
(237.73/274.19)(2C/V)(AU/AS),
in which 237.73and 274.19are the molecular weights of ketamine and ketamine hydrochloride,respectively,Cis the concentration,in µg per mL,of USP Ketamine Hydrochloride RSin the Standard solution,Vis the volume,in mL,of Injection taken,and AUand ASare the absorbances of the solution from the Injection and the Standard solution,respectively.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 1097
Phone Number:1-301-816-8178