Calcium Levulinate Injection
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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.
1 Packaging and storage
Preserve in single-dose containers, preferably of Type I glass.
2 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.
3 Identification
It responds to the Identification tests under Calcium Levulinate.
Bacterial Endotoxins Test 〈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 in Injections 〈788〉: meets the requirements for small-volume injections.
4 Other requirements
It meets the requirements under Injections and Implanted Drug Products 〈1〉.
5 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.
