Development and validation of analytical methods

Need something more than a one-off or cyclical test of a known set of parameters?

Then it is necessary to invent and describe the path first - the procedure, types and scopes of the analyses - so that the result makes sense and meets all the requirements.

Do you have other essential tasks that require the full concentration of your team and no free capacity?

Then we are here to help! Our laboratory is home to a wide range of experts and top-notch technical equipment for solving diverse requirements for the development of analytical methods for a wide spectrum of industrial fields.

Most often, similar requests come from our clients from the pharmaceuticals industry.

This is mainly about testing for impurities (presence of metals, residual volatile solvents, nitrosamines). When choosing a method, we are guided by the specific needs and requirements of the customer. Acceptance of the order is always preceded by consultations and mutual agreement of the proposed procedure and parameters. In this way, we guarantee that the developed method will have the maximum reporting capacity for the planned use, including the fulfilment of the requirements of the regulatory authorities.

In the field of pharmacy, this activity is governed by ICH guidelines and pharmacopoeias, or FDA guidelines.

The suitability of the method is subsequently validated, which includes the following chapters:

• System suitability test
• Accuracy
• Precision
• Repeatability
• Intermediate precision
• Reproducibility
• Detection limit
• Quantitation limit
• Linearity
• Specificity
• Range
• Robustness

All activities are properly documented (SOP methods, validation plan-protocol, validation report) and covered by a confidentiality agreement.

If required, we can also participate in the preparation and transfer of the method.

The documentation is optionally prepared in Czech or English.