The role of pharmaceutical-grade disodium edetate in drug development

The role of pharmaceutical grade disodium edetate in drug research and development This product is ethylenediaminetetraacetate disodium salt dihydrate
.
According to the calculation of dry product, the content of C10H14N2Na2O8 shall not be less than 99.
0%.

【Properties】This product is white or off-white crystalline powder
.
This product is soluble in water and almost insoluble
in methanol, ethanol or .
【Identification】(1) take 2g of this product, add 25ml of water to dissolve, add 6ml of 3.
3% solution, shake, add 3ml of potassium iodide test solution, no yellow precipitate; Adjust to alkaline with ammonia test solution, and add 3ml of ammonium oxalate test solution without precipitation
.
(2) take this product, dry under reduced pressure at 50 °C for 4 hours, and its infrared light absorption spectrum should be consistent
with the control spectrum (spectral set 978 figure).
(3) The identification reaction of sodium salt of this product (General 0301).

【Inspection】Complexation force test take this product, weigh it accurately, dissolve it with water and dilute it to make a 0.
01mol/L solution as a test solution; Accurately weigh 0.
10g of calcium carbonate dried at 200 °C for 2 hours, put it in a 100ml measuring flask, add 10ml of water and 0.
8ml of 6mol/L hydrochloric acid solution to dissolve, adjust to neutral with ammonia test solution, dilute to the scale with water, shake well, and use it as a test solution (1) (0.
01mol/L); Accurately weigh 0.
250g of copper sulfate, put it in a 100ml measuring flask, dissolve it with water and dilute it to the scale, shake it well, and use it as a test solution (2) (0.
01mol/L).

。 Take 5ml of the test solution accurately, add 3 drops of ammonia test solution and 2.
5ml of 4% ammonium oxalate solution, add test solution (1) 5.
0ml under continuous shaking, the solution should be clear, after shaking for 1 minute, if it is still turbid, add 0.
2ml of the test solution, shake for 1 minute, the solution should be clear; take 5ml of the test solution accurately, add 0.
5ml of ammonia test solution and 0.
5ml of ferrous potassium oxide solution [1], Add 4.
8ml of test solution (2) under constant shaking, the solution should be light blue, not red
.
acidity take 0.
50g of this product, add 10ml of water to dissolve, and determine according to law (General 0631), the pH value should be 4.
0~5.
0
.