16037-91-5
Action and use
Pentavalent antimony compound; antiprotozoal.
Preparation
Sodium Stibogluconate Injection
DEFINITION
Sodium Stibogluconate is mainly the disodium salt of μ-oxy-bis[gluconato(3-)-O2 , O3 ,O4 -hydroxoantimony]. It contains not less than 30.0% and not more than 34.0% of antimony(V), calculated with reference to the dried and methanol-free substance.
PRODUCTION
The method of manufacture is such as to ensure consistently controlled reaction stoichiometry in order to yield sodium stibogluconate that is satisfactory with regard to intrinsic toxicity.
CHARACTERISTICS
A colourless, mostly amorphous powder.
Very soluble in water; practically insoluble in ethanol (96%) and in ether.
IDENTIFICATION
A. A solution is dextrorotatory.
B. Pass hydrogen sulfide into a 5% w/v solution for several minutes. An orange precipitate is produced.
C. When heated it chars, without melting, leaving a residue which yields the reactions characteristic of antimony compounds and the reactions characteristic of sodium salts, Appendix VI.
TESTS
Stability and acidity of solution
Heat a solution containing the equivalent of 10% w/v of antimony(V) in an autoclave at 115.5° and at a pressure of 70 kPa for 30 minutes. The resulting solution is colourless or almost colourless and has a pH of 5.0 to 5.6, Appendix V L.
Antimony(III)
Dissolve 2 g in 30 mL of water, add 15 mL of hydrochloric acid and titrate with 0.00833M potassium bromate VS using methyl orange solution as indicator. Not more than 1.3 mL of 0.00833M potassium bromate VS is required.
Chloride
Dissolve 2.5 g in 50 mL of water and add 2 mL of 2M nitric acid and 75 mL of acetate buffer pH 5.0. Titrate with 0.1M silver nitrate VS determining the end point potentiometrically. Not more than 3.0 mL of 0.1M silver nitrate VS is required.
Methanol
Not more than 2.0% w/w when determined by the following method. Carry out the method for gas chromatography, Appendix III B, using the following solutions. For solution (1) add 1 mL of a 1.0% v/v solution of methanol to 5 mL of a 0.2% v/v solution of absolute ethanol (internal standard). For solution (2) add 5 mL of water to 0.5 g of the substance being examined and mix with the aid of ultrasound until solution is complete.
For solution (3) add 5 mL of a 0.2% v/v solution of the internal standard to 0.5 g of the substance being examined and mix with the aid of ultrasound until solution is complete.
The chromatographic procedure may be carried out using a glass column (1.5 m × 4 mm) packed with porous polymer beads (80 to 100 mesh) (Porapak Q and Chromosorb 101 are suitable) and maintained at 130°.
Calculate the percentage w/w of methanol taking 0.792 g as its weight per mL at 20°.
Loss on drying
When dried to constant weight at 130° at a pressure not exceeding 0.7 kPa, loses not more than 15.0% of its weight. Use 1 g.
ASSAY
Dissolve 0.16 g in 30 mL of hydrochloric acid, add 70 mL of orthophosphoric acid and stir carefully until completely mixed.
Titrate with 0.05M ammonium iron(II) sulfate VS prepared using sulfuric acid (1%) and determining the end point potentiometrically using a platinum electrode and a silver-silver chloride reference electrode. Each mL of 0.05M ammonium iron(II) sulfate VS is equivalent to 3.044 mg of antimony(V).
