Pharmaceutical Industry

Method development, validation and transfer

Tailored methods to characterize your products save time and money. Our highly qualified employees, with their many years of experience, will help you develop the right methods. 

For the safety of your product you need robust, valid methods that you can rely on. For validation, we base our procedures on the ICH Guideline and coordinate the final framework to your requirements. We keep you continuously informed throughout the entire process so that you have an overview of the project at all times. (Various disciplines – e.g. heavy metal methods) 

The method exists and is already validated but you need a reliable laboratory that regularly carries out the analyses for you? In this case, we will be glad to transfer the method to our laboratory under the corresponding regulatory conditions.

Pharmacopeial methods

Do you need the analysis to release a packaging material, additive or active ingredient in accordance with a pharmacopeia? 

With online access to the USP and EP and the availability of the latest English translations of the JP, we are able to provide you with quick feedback regarding the viability of the respective test. For current topics, such as the heavy metal tests of the USP and EP, we always have the latest information due to our participation in interest groups, such as the IPEC, so that we can offer you the best solution at short notice. As regards the subject of residual solvents, we offer a basic solution so that verification of your requirements only has to be examined for specific products. Our many years of experience in the area of amino acid analysis provide you with reliable data about the EP analysis of “ninhydrin-positive substances”. 

Other examples of pharmacopeial methods that we use are “concentration”, “identity” (IR, NMR), “purity”, "related substances" and "element determination". 

Of course, the first time we carry out an analysis for you under GMP conditions, we also carry out a separate verification of the pharmacopeial method to comply with the requirements of the authorities.

Characterization of solids

Our diverse portfolio means we can offer a wide array of options for analyzing your samples, using methods that include quality control, microscopic sample analysis, and determinations of characteristic physical parameters. 

You could, for instance, use x-ray powder diffractometry for qualitative and quantitative determination of phase purity and/or the presence of various crystal shapes of active pharmaceutical agents.

We can determine the following key powder characteristics for you: particle distribution (using laser diffraction or light scattering methods), specific surface area (BET method), melting point (capillary method or dynamic differential scanning calorimetry/DSC), loose and compact bulk density, and sieve analyses. 

And when it comes to the details, we’ll take a more precise look using ultramodern methods in electron microscopy and spectroscopy for characterizing surfaces and shapes/structures. Our experts are ready to answer your specific questions, applying methods such as light, scanning electron (SEM), transmission electron (TEM) with a variety of sample preparation techniques as well as infrared and raman microscopy.

Reference substances

With NMR, it is possible to determine the identity and also the concentration of your reference. This is especially useful when there are no substance-related reference standards in an early development phase or if another method is needed to cross-validate a chromatographic method.

We also have a solution if a reference substance is needed for a new, unknown secondary component or a decomposition product from storage experiments. As well as identification via high-resolution LC-MS, Analytics by Evonik also has an option for preparative isolation in the mg range.