C4H4Na2O6·2H2O 230.08

Disodium L-tartrate.
Disodium (+)-2,3-dihydroxybutanedioic acid [868-18-8].

Packaging and storage— Preserve in a tight container. No storage requirements specified.NF24

Identification—

pH 791: between 7 and 9 (1 in 10 solution).

Loss on drying 731— Dry it at 150 for 3 hours: it loses between 14.0% and 17.0% of its weight.

Heavy metals, Method I 231: 0.002%.

Limit of oxalate— Dissolve 1.0 g of Sodium Tartrate in 10 mL of water, then add 5 drops of diluted acetic acid and 2 mL of calcium chloride TS: no turbidity develops within 1 hour. Not more than 0.1% is found.

Residual solvents 467: meets the requirements.

Assay— Transfer about 250 mg of Sodium Tartrate, accurately weighed and previously dried at 150 for 3 hours, to a 250-mL beaker, and dissolve by stirring and heating to near the boiling point in 150 mL of acetic acid. Cool the solution to room temperature. Titrate with 0.1 N perchloric acid VS (in glacial acetic acid), determining the endpoint potentiometrically. Perform a blank determination, and make any necessary adjustments (see Titrimetry 541). Each mL of 0.1 N perchloric acid is equivalent to 9.703 mg of C4H4Na2O6.

Expert Committee : (EM105) Excipient Monographs 1

USP29–NF24 Page 3429

Phone Number : 1-301-816-8262