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Routine Assay

The procedure demonstrated the method's ability to assess analytes in the presence of impurities, matrix components, and degradation products. No interference was found from placebo or mobile phase. Retention times for EPA and DHA standards were about 19 and 23 minutes respectively. The method acceptance limits of up to 1% interference and baseline resolution of R≥1.5% were met. The conclusion was that all parameters met the acceptance criteria and the method is specific.

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45 views2 pages

Routine Assay

The procedure demonstrated the method's ability to assess analytes in the presence of impurities, matrix components, and degradation products. No interference was found from placebo or mobile phase. Retention times for EPA and DHA standards were about 19 and 23 minutes respectively. The method acceptance limits of up to 1% interference and baseline resolution of R≥1.5% were met. The conclusion was that all parameters met the acceptance criteria and the method is specific.

Uploaded by

عبدالعزيز بدر
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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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).

‫هللا اكبر‬

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