替格瑞洛片质量标准和分析方法变更：计划将替格瑞洛片质量标准及分析方法进

Ticagrelor tablets quality standards and analytical methods change: <br>Plan will be amended as follows ticagrelor tablets quality standards and analytical methods: <br>① the next related substances "TCG8, TCG12, TCG16, TCG17 " as an individual impurity not more than 0.2% control, these four process impurities into a single impurity total impurities accordance with the principles calculation and analysis method. <br>Under ② related substances TCG15 limit from "not more than 0.2%, process impurities, not included in total impurities" amended to "not more than 0.1%, process impurities, not included in the total impurities." <br>Other test items remain unchanged. "

替格瑞洛片质量标准和分析方法变更：<br>计划将替格瑞洛片质量标准及分析方法进行如下修订：<br>①将有关物质项下“TCG8、TCG12、TCG16、TCG17”作为单个杂质不得过0.2%进行控制，分析方法中将这四个工艺杂质按照单个杂质原则纳入总杂质计算。<br>②有关物质项下TCG15限度由“不得过0.2%，工艺杂质，不计入总杂质”修订为“不得过0.1%，工艺杂质，不计入总杂质”。<br>其它检测项目保持不变。"

Change of quality standard and analysis method of tegrilol tablets:<br>It is planned to revise the quality standard and analysis method of tegrilol tablets as follows:<br>① The "tcg8, tcg12, tcg16, tcg17" under relevant substances shall be controlled as a single impurity not more than 0.2%. The four process impurities are included in the total impurity calculation according to the principle of single impurity in the analysis method.<br>② The limit of tcg15 under relevant substances is revised from "no more than 0.2%, process impurities, not included in total impurities" to "no more than 0.1%, process impurities, not included in total impurities".<br>Other test items remain unchanged. "