| 1 | Appearance | White Crystalline Powder |
| 2 | Appearance Of Solution | Clear |
| 3 | Identification | Complies |
| 4 | Assay % | 98.5-101.5 |
| 5 | Chloride (as Cl) ppm | ≤ 70 ppm |
| 6 | Loss of Drying, % | ≤0.2 |
| 7 | Heavy Metals % | ≤0.002% |
| 8 | Lead (as Pb) ppm | ≤0.05 ppm |
| 9 | Cadmium ppm | ≤0.05 ppm |
| 10 | Arsenic ppm | ≤0.05 ppm |
| 11 | Mercury % | 0.000010 |
| 12 | Sulphate (as SO4) % | ≤0.0065% |
| 13 | Residue on Ignition, % | ≤0.1 |
| 14 | Related Compounds | Reference As per USP 43 Monogram |
| Monochloroacetic acid % | As per ICH |
| Diglycine % | ≤0.1% |
| Triglycine % | ≤0.1% |
| Glycine anhydride % | ≤0.1% |
| Iminodiacetic acid % | ≤0.1% |
| Hexamethylenetetramine % | ≤0.1% |
| Total Impurities % | ≤1.0% |
| 15 | Residual Solvents | As per ICH guideline Q3C (R8) |
| Chloroform (mcg/gm) | ≤ 60 ppm |
| 1,4-Dioxane (mcg/gm) | ≤ 380 ppm |
| Methylene Chloride (mcg/gm) | ≤ 600 ppm |
| Trichloroethylene | ≤ 80 ppm |
| 16 | Hydrolysable substances | As per USP 43 |
| 17 | Tapped Density (g/cm3) | 1.1 |
| 18 | Bulk Density (g/cm3) | 0.869 |
| 19 | Mesh Size | 20 to 80 Mesh |