| IP | BP/EP | USP NF | |
|---|
| Description | White or almost white crystalline powder | White or almost white crystalline powder | White to off white, odourless crystalline powder |
| Identification | - | By UV | - |
| Appearance of Solution | - | Clear and not more intensely collared than reference solution Y6 | - |
| Solubility | Freely soluble in water, in ethanol (96%) and in methanol | Freely soluble in water, in ethanol (96%) and in methanol | Soluble in water; freely soluble in alcohol; sparingly soluble in chloroform; practically insoluble in benzene and in ether |
| pH | 5.0 to 6.6 | - | 5.0 to 6.6 |
| Acidity/Alkalinity | - | Not more than 0.2 mL of 0.01 NaOH is required to change color of the indicator to yellow | - |
| Related Substances/Impurities (% by HPCL) Xylometazoline Impurity A Any other impurity Total impurities | - | Not more than 0.2%
Not more than 0.2%
Not more than 0.5% | Not more than 0.2%
Not more than 0.10%
Not more than 0.5% |
| Residue on Ignition | - | - | Max 0.1% |
| Iron | 50 ppm | - | - |
| Heavy Metals | - | - | - |
| Sulphated ash | Max 0.1% | Max 0.1% | - |
| Sulphates | 200 ppm | - | - |
| Loss on drying | Max 0.5% | Max 0.5% | Max 0.5% |
| Assay on dried basis | 99.0 % to 101.0% | 99.0 % to 101.0% | 98.0% to 102.0% |
