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USP and Ph. Eur.

Allowable adjustments calculator

USP <621> Allowable Adjustments of Chromatographic conditions – Gradient Elution

Component As per USP Adjustable from Adjustable to Limit
Mobile Phase Gradient Changes

Changes to gradient composition are not recommended

Mobile Phase pH ±0.2 units
Buffer Concentration (mM) ±10%
Column Temperature (°C) ±10°C
Flow Rate (mL/min)

Changes to flow rate are not allowed.

Column Length (mm)

Changes to column length, particle size, or inner diameter are not allowed.

Column Inner Diameter (mm)

Changes to column length, particle size, or inner diameter are not allowed.

Particle Size (µm)

Changes to column length, particle size, or inner diameter are not allowed.

Stationary Phase

No change of the identity of the substituent permitted.

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