The procedure should be able to demonstrate the ability of the method to assess

the analyte in the presence of impurities, matrix components & degradation

products.

9.1. For routine assay:

Placebo interference: No interference.
Mobile phase interference: No interference.
Retention time of standard solution: for Fish oil about 19 minutes for EPA and
about 23minutes for DHA.

Acceptance limit:
1- Up to 1 % interference is accepted.
2- Base line Resolution from any peak in the chromatogram R≥1.5 %.

Conclusion:
All parameters meet the acceptance criteria i.e. the method is specific.

* The Chromatograms and calculations of Specificity are attached in Appendix

(B).

impurities, matrix components & degradation products.

9.1. For routine assay:

Placebo interference: No interference.
Mobile phase interference: No interference.
Retention time of standard solution: for Fish oil about 19 minutes for EPA and
about 23minutes for DHA.

Acceptance limit:
3- Up to 1 % interference is accepted.
4- Base line Resolution from any peak in the chromatogram R≥1.5 %.

Conclusion:
All parameters meet the acceptance criteria i.e. the method is specific.

* The Chromatograms and calculations of Specificity are attached in Appendix

(B).

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