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Determine impurity level in relevant batches1
- 1 Relevant batches are those from development, pilot and scale-up studies. ... batches exhibited unacceptable. bioavailability? ...
1 Relevant batches are those from development, pilot and scale-up studies. ... batches exhibited unacceptable. bioavailability? ...
| PowerPoint PPT presentation | free to view
Determine impurity level in relevant batches1
- of chiral quality could be established alternatively by applying limits to ... 3 A chiral assay or an enantiomeric impurity procedure may be acceptable in lieu ...
of chiral quality could be established alternatively by applying limits to ... 3 A chiral assay or an enantiomeric impurity procedure may be acceptable in lieu ...
| PowerPoint PPT presentation | free to view
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