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 |