C6H8CaO8·4H2O 320.26

D-Glucaric acid,calcium salt (1:1)tetrahydrate.
Calcium D-glucarate (1:1),tetrahydrate [5793-89-5].

Packaging and storage— Preserve in well-closed containers.

USP Reference standards á11ñ— USP Calcium Saccharate RS.

Identification—

Specific rotation á781Sñ: between +18.5and +22.5.

Chloride á221ñ— A0.50-g portion dissolved in 10mLof water by the addition of 2mLof nitric acid shows no more chloride than corresponds to 0.50mLof 0.020Nhydrochloric acid (0.07%).

Sulfate á221ñ— A0.50-g portion dissolved in 10mLof water by the addition of 2mLof hydrochloric acid shows no more sulfate than corresponds to 0.60mLof 0.020Nsulfuric acid (0.12%).

Heavy metals,Method IIá231ñ: 0.002%.

Sucrose and reducing sugars— Dissolve 0.5g in 10mLof water by the addition of 2mLof hydrochloric acid,and boil the solution for about 2minutes.Cool,add 15mLof sodium carbonate TS,allow to stand for 5minutes,and filter.Add 5mLof the clear filtrate to about 2mLof alkaline cupric tartrate TS,and boil for 1minute:no red precipitate is formed immediately.

Organic volatile impurities,Method IVá467ñ: meets the requirements.

Assay— Dissolve about 600mg of Calcium Saccharate,accurately weighed,in 150mLof water with the aid of a sufficient volume of hydrochloric acid.While stirring,preferably with a magnetic stirrer,add about 30mLof 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 16.01mg of C6H8CaO8·4H2O.

Expert Committee:(EMC)Excipients:Monograph Content

USP28–NF23Page 333

Phone Number:1-301-816-8262