Packaging and storage—
Preserve in well-closed containers.
Specific rotation 
781S
:
between +18.5
and +22.5
.
Test solution:
60 mg per mL, in 4.8 N hydrochloric acid that has been allowed to stand for 1 hour.
Chloride 221—
A 0.50-g portion dissolved in 10 mL of water by the addition of 2 mL of nitric acid shows no more chloride than corresponds to 0.50 mL of 0.020 N hydrochloric acid (0.07%).
Sulfate 221—
A 0.50-g portion dissolved in 10 mL of water by the addition of 2 mL of hydrochloric acid shows no more sulfate than corresponds to 0.60 mL of 0.020 N sulfuric acid (0.12%).
Sucrose and reducing sugars—
Dissolve 0.5 g in 10 mL of water by the addition of 2 mL of hydrochloric acid, and boil the solution for about 2 minutes. Cool, add 15 mL of
sodium carbonate TS, allow to stand for 5 minutes, and filter. Add 5 mL of the clear filtrate to about 2 mL of
alkaline cupric tartrate TS, and boil for 1 minute: no red precipitate is formed immediately.
Assay—
Dissolve about 600 mg of Calcium Saccharate, accurately weighed, in 150 mL of water with the aid of a sufficient volume of hydrochloric acid. While stirring, preferably with a magnetic stirrer, add about 30 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 16.01 mg of C6H8CaO8·4H2O.
Auxiliary Information—
Staff Liaison :
Catherine Sheehan, B.Sc., Scientist
Expert Committee : (EM105) Excipient Monographs 1
USP29–NF24 Page 361
Pharmacopeial Forum : Volume No. 27(6) Page 3261
Phone Number : 1-301-816-8262
;)
Infrared Absorption