序号 | 检验项目 | 序号 | 检验项目 |
1 | 预扫描 pre-screen | 18 | 固体燃烧性Flammability(slolids) |
2 | 杂质确认(杂质数量)Identification of Impurity(Number) | 19 | 有机溶剂中溶解度solubility in organic solvent |
3 | 杂质方法确认及含量Impurity Method validation and quantification | 20 | 包材腐蚀性Corrosion Characteristics to Packaging Material |
4 | 有效成分方法验证及含量AI Method validation and quantification | 21 | 倾倒性Pourability of Suspension Concentrates |
5 | 光稳定性Photostability Testing of New Drug Substances and Products | 22 | 水-有机相混溶性Water/ Organic Solvent Miscibility |
6 | 热稳定性Accelerated Storage Procedure | 23 | 金属/金属离子稳定性Stability to Normal and Elevated Temperature, Metals, and Metal Ions |
7 | 冷储稳定性Low Temperature Stability | 24 | 干燥减量 Loss in Weight |
8 | pH值 pH value | 25 | 化学不相容性Chemical Incompatibility |
9 | 酸碱度Acidity/Basidity | 26 | 灼烧残渣 Sulphated Ash |
10 | 水分water content | 27 | 持久起泡性Persistent Foaming |
11 | 沸点 boiling point | 28 | 润湿时间 wetting time |
12 | 分配系数 partition coefficient | 29 | 乳液稳定性Emulsion Characteristics |
13 | 密度 Density | 30 | 悬浮率suspensibility |
14 | 细度 Fineness | 31 | 粘度Viscosity |
15 | 分散性Dispersibility | 32 | 水中溶解度solubility in water |
16 | 丙酮不溶物Material Insoluble Inacetone | 33 | 熔点 melt point |
17 | 闪点 Flash point | 34 | 表面张力 surface tension |