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Recommended System Suitability Testing Acceptance Criteria

Parameter

Assay Type

Acceptance criterion

Capacity Factor

General

2-8

Trace

1-3

Selectivity

General

1.05 - 2.00

Retention Time

General

< 0.1 min

Resolution

General

> 2.0

Quantitative
Biological

> 1.5
> 1.2

Plate Count

General

> 2000

Precision

General

%RSD< 1.5%

Biologicals

%RSD< 5%

Trace
General

%RSD 5-15%
1.5 - 2

Symmetri

Source: Analiticallntrumentation, Encyclopedia of Chromatography, Marcel Dekker 2003

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