Antimony Potassium Tartrate

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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C₈H₄K₂O₁₂Sb₂ · 3H₂O            667.87

C₈H₄K₂O₁₂Sb₂            613.82

Antimonate(2-), bis[u-[2,3-dihydroxybutanedioato(4-)-01,02:03,04]]-di-, dipotassium, trihydrate, stereoisomer;

Dipotassium bis[u-[L-(+)-tartrato(4-)]]diantimonate(2-) trihydrate CAS RN: 28300-74-5; UNII: DL6OZ476V3.

Anhydrous CAS RN: 11071-15-1, UNII: Z8830U53UE

1 DEFINITION

Antimony Potassium Tartrate contains NLT 99.0% and NMT 103.0% of antimony potassium tartrate (C₈H₄K₂O₁₂Sb₂ · 3H₂O).

2 IDENTIFICATION

A.

Sample: An appropriate quantity

Analysis: Heat the Sample to redness.

Acceptance criteria: It chars, emits an odor resembling that of burning sugar, and leaves a blackened residue. This residue has an alkaline reaction, and when a small fragment of it is held in a nonluminous flame, the flame is tinted violet.

B.

Sample solution: Antimony Potassium Tartrate (1 in 20) in water acidified with hydrochloric acid

Analysis: Add hydrogen sulfide TS to the Sample solution.

Acceptance criteria: It yields an orange-red precipitate, which is soluble in ammonium sulfide TS and in 1 N sodium hydroxide.

C. IDENTIFICATION TESTS GENERAL, Tartrate (191): Meets the requirements

3 ASSAY

PROCEDURE

Sample: 500 mg

Analysis: Dissolve the Sample in 50 mL of water, add 5 g of potassium sodium tartrate, 2 g of sodium borate, and 3 mL of starch TS, and immediately titrate with 0.1 N iodine VS to the production of a persistent blue color. Each mL of 0.1 N iodine is equivalent to 16.70 mg of antimony potassium tartrate (C₈H₄K₂O₁₂Sb₂ · 3H₂O).

Acceptance criteria: 99.0%-103.0%

4 IMPURITIES

ARSENIC

Sample solution: Dissolve 100 mg in 5 ml. of hydrochloric acid. Add 10 mL of a recently prepared solution of 20 g of stannous chloride in 30 ml. of hydrochloric acid.

Blank: Add 5 mL of hydrochloric acid to 10 mL of a recently prepared solution of 20 g of stannous chloride in 30 mL of hydrochloric acid.

Analysis: Transfer the Sample solution to a color-comparison tube, and allow to stand for 30 min.

Acceptance criteria: NMT 0.015%; viewed downward over a white surface, the color of the solution appears no deeper than that of the Blank to which has been added 15 µg of arsenic.

Change to read:

LEAD (251), Procedures, Procedure 1 _{(CN 1-Jun-2023)}: NMT 20 ppm

5 SPECIFIC TESTS

COMPLETENESS OF SOLUTION (641)

Sample: 750 mg

Solvent: Water

Acceptance criteria: Meets the requirements

LOSS ON DRYING (731)

Analysis: Dry at 105° to constant weight.

Acceptance criteria: NMT 2.7%

ACIDITY OR ALKALINITY

Sample solution: Dissolve 1.0 g in 50 ml. of carbon dioxide-free water.

Analysis: Titrate the Sample solution with 0.010 N hydrochloric acid or 0.010 N sodium hydroxide to a pH of 4.5.

Acceptance criteria: NMT 2.0 mL

6 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in well-closed containers.