吗替麦考酚酯胶囊（一致性评价）质量标准变更： 1.计划将H0-QS-

Mycophenolate mofetil capsules (consistency Evaluation) Change quality criteria: <br>1. plan H0-QS-22049 mycophenolate mofetil capsules, 0.25g (Evaluation of consistency) quality standards revised as follows: ① insufficient items Reference requirements for content, dissolution, identify 2 amendments. ② According to the conventional description ChP2015 capsule and "chemical pharmaceutical technology research guidelines impurities", respectively, under the revised single unknown impurity properties and related substances. Other test items remain unchanged. <br>2. The program product code 5000284 (100 / vial), 5,000,287 (120 / vial), 5,000,288 (500 / vial) was added to H0-QS-22049 "mycophenolate mofetil capsules, 0.25 g (consistent evaluation) quality standards ", the domestic research for consistency. "

Do you change the quality standard for McCorcortholcecapsule capsules (conformity evaluation): <br> 1. Plan to H0-QS-22049 for McCorcophenol capsules, 0.25g (consistency evaluation) quality standards to be revised as follows: (1) reference to the deficiency requirements for content, solubility, identification 2 revision. (2) According to the general description of the capsules by ChP2015 and the Technical Guidelines for the Study of Chemical Drug Impurities, the characteristics and individual unknown impurities under the substance concerned are revised respectively. Other detection items remain unchanged.<br>2. The product code is 5000284 (100 capsules/bottle), 5000287 (120 capsules/bottle), 5000288 (500 capsules/bottle) to H0-QS-22049 "For McCophenol capsules, 0.25g (consistency evaluation) quality standard" for domestic consistency research. "

Change of quality standard of mycophenolate mofetil capsule (consistency evaluation):<br>1. It is planned to revise the quality standard of h0-qs-22049 metoclopramide capsule and 0.25g (consistency evaluation) as follows: ① revise the content, dissolution and identification 2 with reference to the requirements of insufficient items. ② According to chp2015's general description of the capsule and "technical guidelines for impurity research of chemical drugs", the individual unknown impurities under properties and related substances are revised respectively. Other test items remain unchanged.<br>2. It is planned to add the product code 5000284 (100 capsules / bottle), 5000287 (120 Capsules / bottle), 5000288 (500 capsules / bottle) to h0-qs-22049 "quality standard of motimecorol ester capsule, 0.25g (consistency evaluation)" for domestic consistency research. "<br>