Codeine Phosphate Injection
» Codeine Phosphate Injection is a sterile solution of Codeine Phosphate in Water for Injection. It contains not less than 93.0 percent and not more than 107.0 percent 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 I glass, protected from light.
USP Reference standards 11
USP Codeine Phosphate RS Click to View Structure
USP Endotoxin RS
A: Dilute a volume of Injection, equivalent to about 90 mg of codeine phosphate, with water to about 10 mL, add 1 drop of hydrochloric acid, and extract with three 10-mL portions of chloroform, discarding the chloroform extracts. Add 6 N ammonium hydroxide until the solution is alkaline, and extract with several 10-mL portions of chloroform. Evaporate the combined chloroform extracts on a steam bath to dryness, and dry at 80 for 4 hours: the IR absorption 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 1 mL of a solution of USP Codeine Phosphate RS (1 in 100).
B: A volume of Injection, equivalent to about 60 mg of codeine phosphate, responds to Identification test B under Codeine Phosphate.
Bacterial endotoxins 85 It contains not more than 5.8 USP Endotoxin Units per mg of codeine phosphate.
pH 791: between 3.0 and 6.0.
Limit of morphine— Diluted with water to a concentration of 5 mg of codeine phosphate per mL, it meets the requirements of the test for Limit of morphine under Codeine Phosphate.
Other requirements— It meets the requirements under Injections 1.
Assay— Transfer an accurately measured volume of Injection, equivalent to about 75 mg of codeine phosphate, to a small separator, and add about 15 mL of water. Add 2 drops of phosphoric acid, and extract with four 10-mL portions of chloroform, collecting the chloroform extracts in a separator. Wash the combined chloroform extracts with 10 mL of water, and add the water wash to the first separator containing the sample. Discard the chloroform extracts. Proceed as directed in the Assay under Codeine Phosphate Tablets, beginning with “render the solution alkaline with 6 N ammonium hydroxide.” Each mL of 0.02 N sulfuric acid is equivalent to 8.128 mg of C18H21NO3·H3PO4·½H2O.
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USP35–NF30 Page 2759