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Assay Corrected Result is OOT for B-632 Batch 192D030N (Confirm all IPC…
Assay Corrected Result is OOT for B-632 Batch 192D030N
Confirm all IPC results are typical
All typical, except residual DCM at solvent exchange endpoint is OOT with result of 2.5% v/v
No impact - any residual DCM would be removed during drying (residual DCM in dry cake is below reporting limit)
Confirm IPC chromatograms are typical
Confirmed - no atypical peaks
Confirm OOT result cannot be attributed to sulphuric acid content
Confirmed - sulphuric acid titration result is in trend
Confirm OOT result cannot be attributed to water content
Confirmed - KF result is in trend
Confirm OOT result cannot be attributed to residual solvents content
Confirmed - residual solvents content was below average
Confirm no atypical processing for this batch
Confirmed - batch was processed as normal with no holds or issues on plant
Confirm all other QCATs normal
Confirmed - all other QCATs were typical
Confirm assay of input materials is typical
Confirmed. Two batches of B-101 were used with a weighted average assay value of 100.3%. Eight batches of B-702 were used with a weighted average assay result of 99.5%
Confirm no large discrepancy in assay as-is results of duplicate weighings of batch 192D030N
Confirmed - %RSD between results is 0.5% (spec NMT 1.5%)