Question: Is this good justifcation to remove optical rotation testing? Historically, DZNep HCl is tested by ID and Appearance for release. Optical rotation result reported on
Is this good justifcation to remove optical rotation testing? Historically, DZNep HCl is tested by ID and Appearance for release. Optical rotation result reported on supplier CoA is reviewed against specification. Optical rotation provides information on the chirality of the material. So farTo date, one manufacturing lot of DZNep HCl has been received in two shipments (October 2024 to February 2025) and passed incoming materials testing. In the scenario that one lot of DZNep HCl with incorrect enantiomeric form is received and used in the process, if impactful, a potential reduction in cell population should be seen
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