注射類藥品,為止血藥,其止血機理與氨基己酸相同。止血效果較氨基己酸強5—10倍。用於上消化道出血、滲血、外科手術出血及婦產科病出血等。
基本信息
Item項 目 | Standard標 準 | Results結 果 |
Characteristics性 狀 | White or almost white, crystalline powder白色或類白色結晶粉末 | White crystalline powder白色結晶粉末 |
Solubility溶 解 性 | Freely soluble in water and in glacial acetic acid, practically insoluble in acetone and 96% alcohol易溶於水和冰醋酸,難溶於丙酮和96%乙醇 | Complies符 合 |
Identification鑒 別 | Infrared absorption atlas consistent with the contrast atlas紅外線吸收圖譜應與氨甲環酸的對應圖譜一致 | Complies符 合 |
Clarity and color澄 清 度 | Solution should clarify and colorless 溶液應澄清無色 | Complies符 合 |
PH酸 鹼 度 | 7.0~8.0 | 7.3 |
Related substances Liquid chromatography(2.2.29)相關物質 | Impurity A: ≤0.1%Impurity B: ≤0.2%Any other impurity : ≤0.1%All other impurity : ≤0.2% | 0%0.10%<0.1%<0.2% |
Chlorides氯 化 物 | ≤140ppm | <140ppm |
Heavy Metals重 金 屬 | ≤10ppm | <10ppm |
Loss on drying乾燥失重 | ≤0.5% | 0.13% |
Sulphated Ash硫酸灰份 | ≤0.1% | 0.01% |
Assay含 量 | 99.0%~101.0% | 99.80% |
Conclusion結 論 | Complies with BP2010 specification.符合BP2010要求 |