Laboratory
Development and validation

Development and validation

The development and validation of analytical methods are essential steps in the pharmaceutical industry for ensuring the quality, safety and efficacy of medicinal products. These processes are strictly regulated and follow the guidelines of Good Manufacturing Practice (GMP).

Method development and validation

We offer the development and validation of test methods for identity testing, assay, purity testing and in vitro dissolution for active ingredients, excipients, intermediates, finished products and substance-based medical devices. Our method development and method validation are in accordance with international regulatory requirements and the latest scientific and technical knowledge.

Preparation of development reports, validation plans, and validation reports can be prepared in English, German or French and integrated directly in your marketing-authorisation dossier. The development of appropriate analytical methods is necessary both for release studies and for stability studies of new medicinal products. The method to be developed must be tailored to the specific properties of the active substance.

Various analytical techniques such as chromatography, spectroscopy or mass spectrometry are used for this purpose. With the subsequent validation, we provide proof that the developed method is suitable for the desired application. Validation is mandatory until authorisation is granted and involves the systematic testing of various parameters.

The most important validation parameters include:

Accuracy
Specificity/selectivity
Limit of detection and quantification
Linearity, sensitivity
Repeatability, reproducibility and possibly laboratory precision
Robustness
Working range

Method development and validation: Our range of services

As a GMP and FDA-certified company, we have the necessary experience and expertise to offer you precise method development and method validation.

Identity testing and assay

Identity testing and assay are not only essential for the quality assurance of finished products, but also for the control of active ingredients and other important components during manufacturing.

Chromatography methods (HPLC/UPLC/GC/TLC) with a wide range of detection methods
LC-MS, GC-MS
Electrophoresis with different detection methods
Spectroscopic methods
Titrimetric methods

Purity testing

We analyse organic and inorganic impurities. We use analytical techniques such as liquid chromatography, capillary electrophoresis or gas chromatography-mass spectrometry (GC-MS) for this purpose.

Stability testing for impurities, by-products and degradation products of active ingredients and finished products incl. peak-purity evaluation
Forced degradation studies to evaluate degradation paths and mechanisms
Trace analysis of organic and inorganic impurities
Testing for extractables and leachables as well as genotoxic impurities
Differentiation between degradation products and synthesis by-products

In vitro dissolution testing

In vitro dissolution for testing the release of active substances from the dosage form under standardised conditions.

In vitro active-ingredient dissolution of solid dosage forms
In vitro active-ingredient dissolution of semi-solid dosage forms with Franz cell
Evaluation of discriminating properties
In vitro/In vivo correlation

Adiditional services

In addition to method development and validation, we offer other services such as drug development and small batch manufacturing. If you have any questions or would like a personal consultation, please do not hesitate to contact us.