White or almost white, crystalline powder or colorless crystals
Solubility (USP)
Soluble in solutions of alkali hydroxides; very slightly soluble in water.
Solubility (EP, BP)
Practically insoluble in water and in ethanol (96%). It dissolves in dilute solutions of alkali hydroxides
Identification A : FTIR (USP, EP, BP)
Matches with the standard pattern
Identification B (EP, BP)
The solution becomes yellowish
Identification C (EP, BP)
No precipitate is formed
Appearance of solution (EP, BP)
Dissolve 5 gm in 20 mL of dilute sodium hydroxide solution R and dilute to 100 mL with water R, solution is clear and colourless
Impurity A: system suitability: Resolution : HPLC (EP, BP)
>= 7.0 between the peaks due to the iron complex of impurity A and the iron complex of edetic acid
Impurity A (EP, BP)
<= 0.10% (Not more than the area of the corresponding peak in the chromatogram obtained with the reference solution)
Chlorides (EP, BP)
<= 0.02%
Iron (USP)
<= 0.0050%
Iron (EP, BP)
<= 0.0080%
Residue on ignition (USP)
<= 0.20%
Limit of nitrilotriacetic acid 1: system suitability : Resolution: HPLC (USP)
>= 3.0 between the nitrilotriacetic acid and copper peaks
Limit of nitrilotriacetic acid 2: system suitability : Relative standard deviation : HPLC (USP)
<= 2.0%
Limit of nitrilotriacetic acid 3: HPLC (USP)
<= 0.30% (The response of the nitrilotriacetic acid peak of the sample solution does not exceed the difference between the nitrilotriacetic acid peak responses from the standard solution and the sample solution
Sulfated ash (EP, BP)
<= 0.20%
Assay: Zinc sulfate titration (EP, BP)
98.00 - 101.00%
Assay: EDTA Titration (USP)
98.00 - 100.50%
Storage and Shelf Life
Storage
Store below 30°C away from bright light.
Shelf life
48 months.
Usage
Use before expiry date given on the product label.