If fails in correlation coefficient of FTIR

Quality Control
1

If fails in correlation coefficient in FTIR , Limit : 0.99, obtained result 0.89
how can clear this incident.
And in this case , can you proceed re-crystallization as per guideline.

2

We can proceed after recrystallization

3

we have to check other inter related test parameters like purity, XRD, DSC,PSD, BD & TD, assay, water content, LOD. If all these test parameters results are comparable, we can propose for below hypothesis studies with fresh portion of sample-

  1. Check the correlation with different grinding times. Some times sample PSD is more it requires more grinding time.
    2.If material is hygroscopic we have to perform sample preparation at below 50 % RH by using dehumidifier.
    3.If standard form changed/quality changed due to multiple times exposure. We have to pack standard in small packs. To rule out this we have correlate the sample with USP reference standard.
  2. We have to dissolve sample in highly soluble solvent and distill completely and check the IR correlation with standard.