USP Plate Count

[Jay Naidoo]

Is the a guideline on plate count for system suitability.

CDER recommends >2000

If I have a plate count of the first analyte of 1700, is the system suitable.

Jay

[tom jupille]

2000 is a recommendation, not a requirement.

If this is a validated method and its system suitability criteria call for 2000 plates, then no, your system is not suitable.

If you are developing and validating a method, then you should put in appropriate system suitability parameters. If it is a simple assay with no interfering peaks, and you can prove that the method meets your criteria for accuracy, precision, etc., then 1700 may be adequate. But, because your plate count is lower than the "recommendation", you should expect some difficulty from reviewers!