Calcium Saccharate
(kal' see um sak' a rate).
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d-Glucaric acid, calcium salt (1:1) tetrahydrate;    
Calcium d-glucarate (1:1), tetrahydrate    [5793-89-5].
Calcium Saccharate is the calcium salt of d-saccharic acid. It contains NLT 98.5% and NMT 102.0% of C6H8CaO8·4H2O.
•  A. Identification Tests—General, Calcium 191
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
•  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%
•  Chloride and Sulfate, Chloride 221
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%
•  Chloride and Sulfate, Sulfate 221
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%
•  Heavy Metals, Method II 231: 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.
•  Optical Rotation, Specific Rotation 781S
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
•  Packaging and Storage: Preserve in well-closed containers.
•  USP Reference Standards 11
USP Calcium Saccharate RS Click to View Structure
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/QuestionContactExpert Committee
MonographRobert H. Lafaver, M.S.
Scientific Liaison
(EXC2010) Monographs - Excipients
Reference StandardsRS Technical Services
USP35–NF30 Page 2467
Pharmacopeial Forum: Volume No. 27(6) Page 3261
Chromatographic Column— 
Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30.