| ²é¿´: 331 | »Ø¸´: 0 | ||
| ¡¾ÐüÉͽð±Ò¡¿»Ø´ð±¾ÌûÎÊÌ⣬×÷Õßwxy760428½«ÔùËÍÄú 5 ¸ö½ð±Ò | ||
wxy760428Ìú¸Ëľ³æ (ÕýʽдÊÖ)
|
[ÇóÖú]
ÇóÖú£¬·ÒëÒ»¶ÎÎÄÕ¡£
|
|
|
Understand process parameters and impact on residual impurity levels (including fate and purge knowledge) with sufficient confidence that the level of the impurity in the drug substance will be below the acceptable limit such that no analytical testing is recommended for this impurity. ÌØ±ðÊÇÀ¨ºÅÀïµÄ·Òë¡£ |
» ²ÂÄãϲ»¶
Ò»Ö¾Ô¸Éî´ó085601²ÄÁϹ¤³Ìרҵ£¨×¨Ë¶£©300·Ö¿ÉÒÔµ÷¼ÁÈ¥ÄÄ
ÒѾÓÐ12È˻ظ´
Ò»Ö¾Ô¸»ª¶«Àí¹¤085601²ÄÁϹ¤³Ì303·ÖÇóµ÷¼Á
ÒѾÓÐ11È˻ظ´
266Çóµ÷¼Á
ÒѾÓÐ17È˻ظ´
324Çóµ÷¼Á
ÒѾÓÐ11È˻ظ´
0703µ÷¼Á£¬Ò»Ö¾Ô¸Ìì½ò´óѧ319·Ö
ÒѾÓÐ24È˻ظ´
»úеר˶273ÇëÇóµ÷¼Á
ÒѾÓÐ5È˻ظ´
Çóµ÷¼Á²ÄÁÏ¿ÆÑ§Ó빤³ÌÒ»Ö¾Ô¸985³õÊÔ365·Ö
ÒѾÓÐ3È˻ظ´
Ò»Ö¾Ô¸2110£¬»¯Ñ§Ñ§Ë¶310·Ö£¬±¾¿ÆÖصãË«·ÇÇóµ÷¼Á
ÒѾÓÐ10È˻ظ´
281Çóµ÷¼Á
ÒѾÓÐ10È˻ظ´
²ÄÁÏר˶322·Ö
ÒѾÓÐ12È˻ظ´














»Ø¸´´ËÂ¥