Analyses

Oligos

Proteins

Metabolites

NMR

Pre-Assay Characterization

Your need for rapid assay turnaround time is important, but one must also pay particular attention to scientific integrity. It is equally important that you can trust the assay results from your metabolic screens.  Frequently drug candidates have purity, solubility and chemical stability issues that go undetected.  These can generate misleading results while screening that are difficult to troubleshoot post-assay.  We at Novatia advocate starting with the Pre-assay Integrity Screening to characterize your compounds in the context of the assay.  This is to insure quality results from your submitted samples.

The Pre-assay Integrity Screen determines the ìdrug candidateísî purity, stability, solubility and MS performance from two samples using LC/UV/MS:  one sample dissolved in 100% organic and the other in assay buffer.

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Pre-Assay Results Are As Follows:

  • Purity is calculated from the organic sample based on UV %area
  • Solubility is calculated from the ratio of MS and UV signals between the organic and assay buffer samples
  • Stability is assessed from the appearance of additional peaks in the assay buffer sample
  • MS performance is evaluated using overall signal and observed fragmentation

PAC_Traces: Pre-Assay Characterization Traces

PAC_Table_1: Pre-Assay Characterization Table 1

Even if you have this type of information already in-hand, it is still recommended to use Novatia's approach, which is performed just prior to any assay...and designed specifically for answering questions related to in-vitro metabolism studies.

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