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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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