Specifications | |
---|---|
Assay (bromatometric, calculated on dried substance) | 99.0 - 100.5 % |
Identity | passes test |
Appearance of solution | passes test |
Acidity or alkalinity | passes test |
Melting range (lower value) | ≥ 109 °C |
Melting range (upper value) | ≤ 111 °C |
Heavy metals (as Pb) | ≤ 0.0005 % |
Catechol | ≤ 0.1 % |
Phenol | ≤ 0.01 % |
Related substances | passes test |
Dichloromethane (HS-GC) | ≤ 600 ppm |
Other residual solvents (ICH Q3C) | excluded by production process |
Loss on drying | ≤ 1.0 % |
Sulfated ash | ≤ 0.02 % |
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, USP |