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Selecting a proper System Suitability Testing mixture is essential to check the specifications of a liquid chromatographic system. System Suitability Testing limits are acceptance criteria that must be met prior to sample analysis. Some of the common chromatographic systems used in pharmaceutical sample analyses are:
=>> Active ingredient assays
=>> Impurity determinations
=>> Dissolution testing
The System Suitability Testing limits should conform to the guidelines provided by CDER (Center for Drug Evaluation and Research). Other sources for referencing about the System Suitability Testing are the USP (United States Pharmacopeia) and the ICH (The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use). Especially, one of the ICH’s guidelines has a section dealing entirely with the System Suitability Testing. Some parameters which can be checked using the System Suitability Testing are:
=>> Resolution
=>> Retention time
=>> Pressure
=>> Column efficiency
=>> Repeatability
=>> Plate Number
=>> Tailing factor
=>> Signal-to-noise ratio
