Specifications | |
---|---|
Assay (alkalimetric after oxidation) | 83.5 - 88.5 % |
Identity | passes test |
Appearance of solution | passes test |
Acidity or alkalinity | passes test |
Refractive index (n 20/D) | 1.449 - 1.455 |
Density (d 20/4) | 1.216 - 1.233 g/cm³ |
Chloride (Cl) | ≤ 0.0010 % |
halogenated compounds (as Cl) | ≤ 0.0030 % |
Heavy metals (as Pb) | ≤ 0.0005 % |
Aldehydes | ≤ 10 ppm |
Acetone | ≤ 0.5 % |
Other residual solvents (ICH Q3C) | ...excluded by production process |
Diethylene glycol and related Substances (impurity A) | ≤ 0.1 % |
Diethylene glycol and related Substances (any further impurity) | ≤ 0.1 % |
Diethylene glycol and related Substances (Sum of all impurities) | ≤ 0.5 % |
Esters | passes test |
Sugar | passes test |
Sulfated ash | ≤ 0.01 % |
Water | 12.0 - 16.0 % |
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). |
|
Corresponds to Ph Eur, BP |