Calcium Gluceptate Injection
»Calcium Gluceptate Injection is a sterile solution of Calcium Gluceptate in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of calcium (Ca).
Packaging and storage— Preserve in tight,single-dose containers,preferably of Type Ior Type IIglass.
Labeling— The label states the total osmolar concentration in mOsmol per liter.Where the contents are less than 100mL,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.
Identification—
A:Infrared Absorption á197Kñ— Prepare the test specimen as follows.Transfer 5mLof Injection to a separator,add 10mLof chloroform,shake,and allow the layers to separate.Draw off and discard the chloroform layer,and repeat the extraction with a second 10-mLportion of chloroform.Drain the water layer into a small beaker,evaporate to dryness,and dry in vacuum at 60for 16hours.
B: Adilution of the Injection with water (1in 5)responds to the tests for Calcium á191ñ.
Bacterial endotoxins á85ñ— It contains not more than 0.32USP Endotoxin Unit per mg of calcium gluceptate.
pHá791ñ: between 5.6and 7.0.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— To an accurately measured volume of Injection,equivalent to about 45mg of calcium,add 2mLof 3Nhydrochloric acid and 148mLof water.While stirring,preferably with a magnetic stirrer,add about 15mLof 0.05Medetate disodium VSfrom a 50-mLburet.Add 15mLof 1Nsodium hydroxide and 300mg of hydroxy naphthol blue,and continue the titration to a blue endpoint.Each mLof 0.05Medetate disodium is equivalent to 2.004mg of calcium (Ca).
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 326
Pharmacopeial Forum:Volume No.27(6)Page 3257
Phone Number:1-301-816-8389