指标名称 | Name of index | BP2010 | E-331(iii) | USP-30 | |
外观 | Description | Crystalline white powder or colourless crystals | |||
含量 | Content( anhydrous basis) | % | 99.0-101.0 | ≥99.0 | 99.0-100.5 |
溶解度 | Solubility | Freely soluble in water, practically insoluble in ethanol (96 per cent) | -- | -- | |
鉴别试验 | Identification | >Pass test | Pass test | Pass test | |
溶液外观 | Appearance of solution | Solution is clear and colourless | -- | -- | |
酸碱度 | Acidity or Alkalinity | Pass test | -- | Pass test | |
酒石酸盐 | Tartrate | -- | -- | Pass test | |
硫酸盐 | Sulphate | ≤% | 0.015 | -- | -- |
重金属 | Heavy metals | ≤% | 0.001 | -- | 0.001 |
草酸盐 | Oxalate(As H2C2O4) | ≤% | 0.03 | 0.01 | -- |
氯化物 | Chloride | ≤% | 0.005 | -- | -- |
干燥失重 | Loss on drying, | % | 11.0-13.0 | 10.0-13.0 (180 °C, 18 hours) | 10.0-13.0 (180 °C, 18 hours) |
致热源 | Pyrogens | Pass test | -- | -- | |
易碳化物 | Readily carbonisable substances | Pass test | -- | -- | |
pH值(5%水溶液) | pH value(5% aqueous solution) | -- | 7.5-9.0 | -- | |
砷 | Arsenic(As) | ≤ppm | -- | 1 | -- |
铅 | Lead(Pb) | ≤ppm | -- | 2 | -- |
汞 | Mercury(Hg) | ≤ppm | -- | 1 | -- |