Assay (GC) | ≥ 99.0 % |
Özdeşlik (IR) | conforms |
Özdeşlik B (Ph Eur) | conforms |
Özdeşlik C (Ph Eur) | conforms |
Özdeşlik B (NF) | conforms |
Özdeşlik (JPE) | conforms |
Su-inÇözünür substances | conforms |
Appearance of solution | conforms |
Asitlik or alkalinity | conforms |
Yoğunluk (d 20 °C/20 °C) | 0.790 - 0.793 |
Yoğunluk (d 25 °C/25 °C) | ≤ 0.789 |
Reducing substances | conforms |
Readily oxidizable substances | conforms |
Potassium permanganate-reducing substances | conforms |
Phenole | conforms |
Cu (Copper)* | ≤ 0.05 ppm |
Related substances (GC) (Methanol (Impurity A)) | ≤ 0.05 % |
Related substances (GC) (2-Propanol (Impurity B)) | ≤ 0.05 % |
Related substances (GC) (Benzene (Impurity C)) | ≤ 2 ppm |
Related substances (GC) (other impurity) | ≤ 0.05 % |
Cyclohexane (residual solvent) (GC) | ≤ 0.01 % |
Other residual solvents (ICH Q3C) | excluded by the manufacturing process |
Buharlaşma Kalıntısı | ≤ 0.0020 % |
Su | ≤ 0.30 % |
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 (*). Conforms to Ph Eur, BP, JPE, NF |