Test Report
Chromatography conditions:
Column |
Welch Ultisil®LP-C18,(4.6×250mm,5μm) |
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Mobile Phase |
Ammonium sulfate-acetonitrile |
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Column Temperature |
50℃ |
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Detector |
UV |
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Injection Volume |
20μL |
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Flow Rate |
1.0 ml/min |
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Detect wavelength |
210 nm |
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Elution procedure |
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Note |
/ |
Chromatogram and Data:
1) Blank
2) System adaptation:
Retention time (min) |
Peak Area |
Peak height |
Resolution(USP) |
Tailing factor |
Number of plates(EP) |
26.816 |
607.38 |
28.75 |
|
1.09833 |
36707.33671 |
27.692 |
6615.32 |
299.36 |
1.52562 |
1.18793 |
35311.8687 |
28.923 |
9.62 |
0.44 |
2.14121 |
1.37611 |
42759.16405 |
30.219 |
30.96 |
0.96 |
1.83447 |
0.79124 |
19856.50640 |
Sum |
7263.28 |
|
|
|
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Conclusion:
Under these HPLC conditions,Using Welch Ultisil® LP-C18, (4.6×250mm, 5μm), the retention time of the main peak is about 30min, and the impurity separation is greater than 1.5. The verification results of the latest batch of two chromatographic columns are repeatable and meet the test requirements.