Cder guidance validating chromatographic methods

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It is not always necessary to validate all analytical parameters that are available for a specific technique.

Renger and his colleagues (12) described the validation of a specific analytical procedure for the analysis of theophylline in a tablet using high-performance thin layer chromatography (HPTLC).

This ensures that one set of consumables can be used for most experiments and avoids unpleasant surprises during method validation.

Operators should be sufficiently familiar with the technique and equipment.

The preparation and execution should follow a validation protocol, preferably written in a step-by-step instruction format.

Possible steps for a complete method validation are listed in Table 1.

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