Codeine Phosphate Injection
»Codeine Phosphate Injection is a sterile solution of Codeine Phosphate in Water for Injection.It contains not less than 93.0percent and not more than 107.0percent of the labeled amount of C18H21NO3·H3PO4·½H2O.
NOTE—Do not use the Injection if it is more than slightly discolored or contains a precipitate.
Packaging and storage—
Preserve in single-dose or multiple-dose containers,preferably of Type Iglass,protected from light.
Identification—
A:
Dilute a volume of Injection,equivalent to about 90mg of codeine phosphate,with water to about 10mL,add 1drop of hydrochloric acid,and extract with three 10-mLportions of chloroform,discarding the chloroform extracts.Add 6Nammonium hydroxide until the solution is alkaline,and extract with several 10-mLportions of chloroform.Evaporate the combined chloroform extracts on a steam bath to dryness,and dry at 80
for 4hours:the IRabsorption spectrum of a potassium bromide dispersion of the residue so obtained exhibits maxima at the same wavelengths as that of the codeine obtained by similarly treating 1mLof a solution of USP Codeine Phosphate RS(1in 100).
for 4hours:the IRabsorption spectrum of a potassium bromide dispersion of the residue so obtained exhibits maxima at the same wavelengths as that of the codeine obtained by similarly treating 1mLof a solution of USP Codeine Phosphate RS(1in 100).
B:
Avolume of Injection,equivalent to about 60mg of codeine phosphate,responds to Identificationtest Bunder Codeine Phosphate.
Bacterial endotoxins á85ñ—
It contains not more than 5.8USP Endotoxin Units per mg of codeine phosphate.
pHá791ñ:
between 3.0and 6.0.
Limit of morphine—
Diluted with water to a concentration of 5mg of codeine phosphate per mL,it meets the requirements of the test for Limit of morphineunder Codeine Phosphate.
Other requirements—
It meets the requirements under Injections á1ñ.
Assay—
Transfer an accurately measured volume of Injection,equivalent to about 75mg of codeine phosphate,to a small separator,and add about 15mLof water.Add 2drops of phosphoric acid,and extract with four 10-mLportions of chloroform,collecting the chloroform extracts in a separator.Wash the combined chloroform extracts with 10mLof water,and add the water wash to the first separator containing the sample.Discard the chloroform extracts.Proceed as directed in the Assayunder Codeine Phosphate Tablets,beginning with “render the solution alkaline with 6Nammonium hydroxide.”Each mLof 0.02Nsulfuric acid is equivalent to 8.128mg of C18H21NO3·H3PO4·½H2O.
Auxiliary Information—
Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 535
Phone Number:1-301-816-8139