Calcium Saccharate
(kal' see um sak' a rate).

C6H8CaO8·4H2O 320.26
d-Glucaric acid, calcium salt (1:1) tetrahydrate;
Calcium d-glucarate (1:1), tetrahydrate     [5793-89-5].
DEFINITION
Calcium Saccharate is the calcium salt of d-saccharic acid. It contains NLT 98.5% and NMT 102.0% of C6H8CaO8·4H2O.
IDENTIFICATION
Sample:  0.2 g
Analysis:  Dissolve the Sample in 10 mL of water by the addition of 2 mL of hydrochloric acid.
Acceptance criteria:  Meets the requirements
•  B. Infrared Absorption 197M: Meets the requirements
ASSAY
•  Procedure
Sample:  600 mg
Blank:  150.0 mL of water
Titrimetric system
Mode:  Direct titration
Titrant:  0.05 M edetate disodium VS
Endpoint detection:  Visual
Analysis:  Dissolve the Sample in 150 mL of water with the aid of a sufficient volume of hydrochloric acid. While stirring, preferably with a magnetic stirrer, add 30 mL of Titrant from a 50-mL buret. Add 15 mL of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue. Continue the titration to a blue endpoint. Perform a Blank determination and make any necessary corrections.
Calculate the percentage of calcium saccharate (C6H8CaO8·4H2O) in the portion of Calcium Saccharate taken:
Result = {[(VS VB) × N × F]/W} × 100
 VS = = Titrant volume consumed by the Sample (mL) VB = = Titrant volume consumed by the Blank (mL) N = = actual normality of the Titrant (mEq/mL) F = = equivalency factor, 320.2 mg/mEq W = = Sample weight (mg)
Acceptance criteria:  98.5%–102.0%
IMPURITIES
Standard:  0.50 mL of 0.020 N hydrochloric acid
Sample:  0.50 g dissolved in 10 mL of water by the addition of 2 mL of nitric acid
Acceptance criteria:  NMT 0.07%
Standard:  0.6 mL of 0.020 N sulfuric acid
Sample:  0.50 g dissolved in 10 mL of water by the addition of 2 mL of hydrochloric acid
Acceptance criteria:  NMT 0.12%
NMT 20 ppm
•  Sucrose and Reducing Sugars
Sample:  0.5 g
Analysis:  Dissolve the Sample in 10 mL of water with the addition of 2 mL of hydrochloric acid, and boil the solution for about 2 min. Cool, add 15 mL of sodium carbonate TS, allow to stand for 5 min, and filter. Add 5 mL of the clear filtrate to about 2 mL of alkaline cupric tartrate TS, and boil for 1 min.
Acceptance criteria:  No red precipitate is formed immediately.
SPECIFIC TESTS
Sample solution:  60 mg/mL in 4.8 N hydrochloric acid that has been allowed to stand for 1 h
Acceptance criteria:  +18.5 to +22.5