Calcium Gluceptate Injection
» Calcium Gluceptate Injection is a sterile solution of Calcium Gluceptate in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of calcium (Ca).
Packaging and storage Preserve in tight, single-dose containers, preferably of Type I or Type II 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
A: Infrared Absorption 197KPrepare the test specimen as follows. Transfer 5 mL of Injection to a separator, add 10 mL of chloroform, shake, and allow the layers to separate. Draw off and discard the chloroform layer, and repeat the extraction with a second 10-mL portion of chloroform. Drain the water layer into a small beaker, evaporate to dryness, and dry in vacuum at 60 for 16 hours.
B: A dilution of the Injection with water (1 in 5) responds to the tests for Calcium 191.
Bacterial endotoxins 85 It contains not more than 0.32 USP Endotoxin Unit per mg of calcium gluceptate.
pH 791: between 5.6 and 7.0.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements under Injections 1.
Assay To an accurately measured volume of Injection, equivalent to about 45 mg of calcium, add 2 mL of 3 N hydrochloric acid and 148 mL of water. While stirring, preferably with a magnetic stirrer, add about 15 mL of 0.05 M edetate disodium VS from a 50-mL buret. Add 15 mL of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue, and continue the titration to a blue endpoint. Each mL of 0.05 M edetate disodium is equivalent to 2.004 mg of calcium (Ca).
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USP35NF30 Page 2453Pharmacopeial Forum: Volume No. 27(6) Page 3257