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USP and Ph. Eur. Allowable Adjustments Calculator
Harmonized Pharmacopeia Adjustments - Isocratic Elution
Stationary Phase
No change of the identity of the substituent (e.g. no replacement of C18 by C8); the other physico-chemical characteristics of the stationary phase (i.e. chromatographic support, surface modification and extent of chemical modification) must be similar; a change from totally porous particle (TPP) columns to superficially porous particle (SPP) columns is allowed provided the above-mentioned requirements are met.
Mobile Phase
Mobile phase minor component (<50%)
Condition as per monograph
Adjustable
range:
range:
35.32 - 55.32
Limit: ±30% (relative) for minor components, but no component is altered by more than ±10% absolute. A minor component comprises ≤ (100/n)% where n is the total number of components. Cannot be reduced to zero.
Limit: ±30% (relative) for minor components, but no component is altered by more than ±10% absolute. A minor component comprises ≤ (100/n)% where n is the total number of components. Cannot be reduced to zero.
pH of Aqueous Component of Mobile Phase
Condition as per monograph
Adjustable
range:
range:
0.80 - 1.20
Limit: ±0.2 pH units, unless otherwise prescribed.
Limit: ±0.2 pH units, unless otherwise prescribed.
Concentration of salts in buffer component of mobile phase (mM)
Condition as per monograph
Adjustable
range:
range:
19.80 - 24.20
Limit: ±10%
Limit: ±10%
Column Temperature (°C)
Condition as per monograph
Adjustable
range:
range:
12 - 32
Limit: ±10 °C, where the operating temperature is specified, unless otherwise prescribed
Limit: ±10 °C, where the operating temperature is specified, unless otherwise prescribed
Column Dimensions
Column Length (mm)
Condition as per monograph
Adjusted
conditions
conditions
The particle size and/or length of the column may be modified provided that the ratio of the column length (L) to the particle size (dp) remains constant or in the range −25% to +50% of the prescribed L/dp ratio.
Column Diameter (mm)
Condition as per monograph
Adjusted
conditions
conditions
The particle size and/or length of the column may be modified provided that the ratio of the column length (L) to the particle size (dp) remains constant or in the range −25% to +50% of the prescribed L/dp ratio.
Particle Size (µm)
Condition as per monograph
Adjusted
conditions
conditions
The particle size and/or length of the column may be modified provided that the ratio of the column length (L) to the particle size (dp) remains constant or in the range −25% to +50% of the prescribed L/dp ratio.
L/dp
Condition as per Monograph
Adjusted conditions
The column with desired dimension
L/dp deviation
Condition as per Monograph
50
Adjusted
conditions
conditions
50
The column with desired dimension
✓Can be Used
L/dp deviation
0.00%
Flow Rate
Adjusted flow rate:
1.322 mL/min
After an adjustment due to a change in column dimensions, an additional change in flow rate of ± 50 % is permitted.
After an adjustment due to a change in column dimensions, an additional change in flow rate of ± 50 % is permitted.
Injection Volume (µL)
Adjusted injection volume:
33 µL
When the column dimensions are changed, the injection volume may be adjusted accordingly.
When the column dimensions are changed, the injection volume may be adjusted accordingly.
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