Assay (GC) | ≥ 99.5 % |
Özdeşlik (IR) | conforms |
Özdeşlik B (USP) | conforms |
Özdeşlik (JP) | conforms |
Özdeşlik (ChP) | conforms |
Appearance | conforms |
Clarity of solution | conforms |
Clarity and color of solution | conforms |
Su-inÇözünür substances | conforms |
Asitlik or alkalinity | conforms |
Asitlik | conforms |
Refractive index (n 20/D) | 1.376 - 1.378 |
Yoğunluk (d 20 °C/20 °C) | 0.785 - 0.788 |
Yoğunluk (d 25 °C/25 °C) | 0.783 - 0.787 |
Kaynama aralığı (81-83°C) | ≥ 94 % (v/v) |
Absorbance (at 230 nm) | ≤ 0.300 |
Absorbance (at 250 nm) | ≤ 0.100 |
Absorbance (at 270 nm) | ≤ 0.030 |
Absorbance (at 290 nm) | ≤ 0.020 |
Absorbance (at 310 nm) | ≤ 0.010 |
The spectrum shows a steadily descending curve with no observable peaks or shoulders | conforms |
Carbonyl compounds (CO) | conforms |
Readily oxidizable substances | conforms |
Readily carbonizable substances | conforms |
Peroxides | conforms |
Ni (Nickel)* | ≤ 0.05 ppm |
Volatile Impurities (GC) (Methanol) | ≤ 0.02 % (v/v) |
Volatile Impurities (GC) (Individual known impurity (ethyl ether, acetone, diisopropyl ether, 1-propanol, 2-butanol)) | ≤ 0.1 % (v/v) |
Volatile Impurities (GC) (Individual unspecified impurity) | ≤ 0.1 % (v/v) |
Volatile Impurities (GC) (total) | ≤ 1.0 % (v/v) |
Benzene and related substances (GC) (Benzene) | ≤ 1 ppm |
Benzene and related substances (GC) (total of impurities apart from 2-butanol) | ≤ 0.3 % |
Cyclohexane (GC) | ≤ 50 ppm |
Acetone (GC) | ≤ 50 ppm |
Ethanol (GC) | ≤ 50 ppm |
Methanol (GC) | ≤ 200 ppm |
1-Propylalcohol (GC) | ≤ 300 ppm |
Isopropylether (GC) | ≤ 0.01 % |
Other residual solvents (ICH Q3C) | excluded by manufacturing process |
Buharlaşma Kalıntısı | ≤ 0.0020 % |
Non-volatile matter | ≤ 0.0020 % |
Su | ≤ 0.20 % |
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, ChP, JP, USP |