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4. QC 相关
(1)稀释至…刻度
Add 1 mg of × to 10 mL of methanol and dilute to 50 mL with water.
(2)从不同部位取样
During drying, the drug substance is sampled from different sampling points/locations.
(3)额外的测试
Additional testing should be considered for reprocessed batches.
(4)进入/接近…
Access to system should be restricted by password.
(5)备份
Back up the data on a daily basis.
(6)…与…的分离度不得小于…
The resolution between … and … should be not less than …
(7)导致…
This deviation may lead to test failure.
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