Calcium Saccharate USP
C6H8CaO8-4H2O 320.26
D-Glucaric acid, calcium salt (1:1) tetrahydrate.
Calcium D-glucarate (1:1), tetrahydrate CAS 5793-89-5
Calcium Saccharate is the calcium salt of D-saccharic acid. It contains not less than 98.5 percent and not more than 102.0 percent of C6H8CaO8-4H2O.
Identification:
A: Dissolve about 0.2 g in 10 mL of water by the addition of 2 mL of hydrochloric acid: the solution so obtained responds to the tests for Calcium.
B: Infrared Absorption 197M.
Specific rotation: 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 1hour.
Chloride: 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: 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%).
Heavy metals: 0.002%.
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 edta disodium VS from a 50-mL burette. 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 edta disodium is equivalent to 16.01 mg of C6H8CaO8-4H2O.
Certifications :
We manufacture Bulk Drugs / API, Excipients,
Pharmaceuticals (IP/BP/USP/NF/Ph. Eur, JP/ CP), Speciality Chemicals(Pure/AR/ACS), Mineral
Fortifiers, Food Chemical Codex (FCC) and Flavour chemicals. Our manufacturing facility is cGMP,
GLP, ISO 9001, ISO 14001, ISO 22000, ISO/IEC 17025, FSSC 22000, FSSAI, Kosher, HALAL, EXCiPACT, WC,
COPP, WHO-GMP and WC certified. We are also REACH registered for export to European countries.