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| Component | As per Ph. Eur. monograph | Adjustable from | Adjustable to | Limit |
|---|---|---|---|---|
| Composition of the Mobile Phase + Gradient | Minor adjustments of the composition of the mobile phase and the gradient are acceptable, if the system suitability requirements are met, the principle peak(s) elute(s) within ± 15 % of the indicated retention time(s) and the final elution power of the mobile phase is not weaker. |
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| Mobile Phase pH | No adjustment permitted |
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| Buffer Concentration (mM) | No adjustment permitted |
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| Column Temperature (°C) | ±5°C | |||
| Flow Rate (mL/min) | Adjustment is permitted to maintain linear velocity when changing column dimensions |
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| Column Length (mm) | ±70% | |||
| Column Inner Diameter (mm) | ±25% | |||
| Particle Size (µm) | No change permitted. |
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| Stationary Phase | No change of the identity of the substituent permitted. |
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| Column dimension as per EP | Desired Column Dimensions | |||
| Column Length (mm) | ||||
| Column Inner Diameter (mm) | ||||
| Flow Rate As per Ph. Eur. Monograph (mL/min) | ||||
| Recommended Flow Rate To Maintain Linear Velocity (mL/min) | ||||
Choose Phenomenex columns for your analysis |
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| Description according to Pharm. Eur. 10, 4.1.1 Reagents 2020 | Number | Recommended Phenomenex Column | ||||
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