Testing of Active Ingredients

Stability testing of pharmaceuticals according to the European Pharmacopoeia · Studies on metabolites, method development and validation · Physical/chemical testing of chemicals · Analyses for approval of plant protection agents

Testing is done according to GLP
(Good laboratory practice)

Our expertise includes stability testing of pharmaceutical products, characterization of chemicals and the analysis of chemical residues. Further important activities include validation as well as metabolism studies. All testing done is performed under strict GLP regulations and standards.

We take pride in delivering results within agreed deadlines, assuring absolute confidentiality. In addition, we provide a comprehensive consulting service and respond with high flexibility to customer requirements. Adaption of existing working procedures supplied by our clients or development of new methods, is done according to customers requests.

Stability testing

Stability testing of pharmaceuticals is accomplished in accordance with relevant EU and ICH-Guidelines and the European Pharmacopoeia.

Three storage conditions as required by ICH requirements, (±2°C and ±5% relative humidity) in the temperature range from 5 to 45°C and in 40 to 95% relative humidity can be provided simultaneously.

Test parameters

• Content of active components using HPLC, LC/MS, GC or GC/MS
• Purity control (determination of degradation and/or byproducts)
• Dissolution using a spectral photometer or HPLC
• Pressure stability
• Resistance to abrasion
• Water content by Karl Fischer-titration
• Decomposition time
• Degree of dispersion (grain size)
• Equilibrium humidity
• Mass uniformity
• Total germ count
• Organoleptic tests

Residue analysis

Special tests are devised for herbicides and pesticides. Regulatory requirements demand investigations into the active ingredients and potential metabolites. In cooperation with the division Environmental research, environmental field testing of biocidal compounds can be carried out.