These vials are less resistant than molded glass vials and may shed lamellae more easily (Ennis, Pritchard, et al. 2001). API manufacturers perform analytical testing on APIs to confirm that ...

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Jun 23, 2021 · Usually 200 vials is sufficient. We recommend that the WCB be made after an investigational new drug (IND) application is filed and clinical testing begins. Using two or three vials from the MCB for production of phase 1 clinical testing materials saves time and money at that urgent stage of production.

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