吗替麦考酚酯片和胶囊质量标准变更：根据ICHQ3B要求计划将吗替麦考酚

Mycophenolate mofetil sheet and the Quality Standard changes: <br>The requirements plan ICHQ3B mycophenolate mofetil sheet, USP500mg and mycophenolate mofetil capsules, USP250mg product quality standards, intermediate quality standards, quality standards stability and related research programs related to the stability of the substance under the item "single unknown impurity: not more than 0.1%" amended to "single unknown impurity: not more than 0.10%" other test items remain unchanged. "

吗替麦考酚酯片和胶囊质量标准变更：<br>根据ICHQ3B要求计划将吗替麦考酚酯片，USP500mg和吗替麦考酚酯胶囊，USP250mg成品质量标准、中间体质量标准、稳定性质量标准和相关的稳定性研究方案中有关物质项下“单个未知杂质：不得过0.1%”修订为“单个未知杂质：不得过0.10%”其它检测项目保持不变。"

Changes in the quality standard of mycophenolate tablets and capsules:<br>According to the requirements of ichq3b, we plan to revise "single unknown impurity: no more than 0.1%" to "single unknown impurity: no more than 0.10%" under the relevant substances in the quality standards of product, intermediate, stability quality standards and relevant stability research plans of motimecorol ester tablets, usp500mg and motimecorol ester capsules, usp250mg, and other test items remain unchanged. "<br>