默克药用有机溶剂符合通行的药典要求,并在此基础上制定了更为严格的内控标准,广泛使用于药物溶解、包衣液配置、粘合剂配置等多种工艺中。

货号:100967

品名:Ethanol 96% suitable for use as excipient EMPROVE® Essential Ph Eur,JP,USP

 

中文名:乙醇(96%

乙醇(96%)Ethanol 96% 100967
规格
Assay (d20°C/4°C) (m/m) 92.6 - 95.2 %
Assay (d20°C/4°C) (V/V) 95.1 - 96.9 %
Assay (d 15°C/15°C) (V/V) 95.1 - 96.9 %
Assay (d15.56°C/15.56°C) (m/m) 92.3 - 93.8 %
Assay (d15.56°C/15.56°C) (V/V) 94.9 - 96.0 %
Identity (IR) conforms
Appearance conforms
Clarity of solution conforms
Color of solution conforms
Acidity or alkalinity ≤ 30 ppm
Density (d 20 °C/20 °C) 0.805 - 0.812
Density (d 15 °C/15 °C) 0.809 - 0.816
Density (d 15,56 °C/15,56 °C) 0.812 - 0.816
Specific gravity (d 15 °C/15 °C) 0.80872 - 0.81601
Absorbance (at 240 nm) ≤ 0.40
Absorbance (between 250nm and 260nm) ≤ 0.30
Absorbance (between 270nm and 340nm) ≤ 0.10
The spectrum shows a steadily descending curve with no observable peaks or shoulders conforms
Volatile impurities (Acetaldehyde and Acetal) ≤ 10 ppm
Volatile impurities (Benzene) ≤ 2 ppm
Volatile impurities (Methanol) ≤ 200 ppm
Volatile impurities (Total of other impurities) ≤ 300 ppm
Volatile impurities (disregard limit) ≤ 9 ppm
Residual solvents (ICH Q3C) excluded by the manufacturing process
Evaporation residue ≤ 25 mg/l
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, JP, USP.