Calcium Levulinate Injection
» Calcium Levulinate Injection is a sterile solution of Calcium Levulinate in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C10H14CaO6·2H2O.
Packaging and storage Preserve in single-dose containers, preferably of Type I glass.
Labeling The label states the total osmolar concentration in mOsmol per L. Where the contents are less than 100 mL, or where the label states that the Injection is not for direct injection but is to be diluted before use, the label alternatively may state the total osmolar concentration in mOsmol per mL.
USP Reference standards 11
USP Endotoxin RS
Identification It responds to the Identification tests under Calcium Levulinate.
Bacterial endotoxins 85 It contains not more than 35.70 USP Endotoxin Units per mg of calcium levulinate.
pH 791: between 6.0 and 8.0.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements under Injections 1.
Assay Transfer an accurately measured volume of Injection, equivalent to about 600 mg of calcium levulinate, to a 400-mL beaker, add 2 mL of hydrochloric acid, and proceed as directed in the Assay under Calcium Levulinate, beginning with While stirring with a magnetic stirrer. Each mL of 0.05 M edetate disodium is equivalent to 15.32 mg of C10H14CaO6·2H2O.
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USP35NF30 Page 2460