Analytical Services

One focus of our work is the development and validation of specific analytical methods for testing finished medicinal products and raw materials for the determination of assay, analysis of known and unknown impurities, as well as dissolutions from solid and semi-Solid dosage forms using various measurement techniques. If required, we can also optimize existing methods for you.
The method development is based on Pharmacopoeia and/ or suitable literature-methods and requires qualified specialists with many years of experience. In close cooperation with our customers, we adjust the chosen method to the requirements of their product.
Subsequently, these methods can be validated according to the European guideline ICH Q2 (R1) and according to customer requirements. 

Validation parameters are defined individually. Characteristic parameters of methods are, for example:

• Specificity/ Selectivity
• Linearity
• Limit of quantification (LOQ) and Limit of detection (LOD)
• Working range
• Accuracy/ Recovery
• Precision/ Intermediate Precision
• Stabilities of solutions
• Robustness (influence of critical parameters, stability of solutions)
• Degradation study as part of the robustness for a purity method (stress conditions: photolytic, thermal, oxidative, acidic and alkaline stress as well as the influence of metal ions)

In addition to the analytical part, we also create a validation plan based on the specifications of the customer and/or the authorities. Our experience of regulatory requirements covers not only the European market, but also the Japanese and Brazilian markets. After the plan has been approved by both parties, the analysis is carried out and finally we create the validation report.

A comprehensive validation report with all validation data in German or English rounds off our offer. This means that the results can be tracked at any time.

If developed and validated analysis methods are to be used for routine analysis, a method transfer is usually required in advance.

Existing methods can be established on site or transferred to another laboratory. We not only offer analytical support, but are also happy to draw up a method transfer plan and report. When defining the scope, acceptance criteria and schedule, we closely follow the customer's specifications. Open communication is essential to ensure a rapid introduction of the method into the routine.


Method verification

Before testing customer-specific products/raw materials with already established and validated methods (e.g. pharmacopoeia methods), a method verification is usually carried out. We support our customers in the implementation of the verification and determine the scope in cooperation with them. This usually includes a reduced scope of validation and is defined in accordance with pharmacopoeia specifications or internal customer requirements. In addition to the verification plan, a method verification also includes a comprehensive verification report, which we provide with all the necessary data upon completion. The customer is involved at every step to ensure complete traceability and transparency.

Our customers receive complete stability studies in accordance with ICH specifications, from the storage of samples in our in-house climatic chambers to on-time analysis and careful documentation, all from a single source. This saves time, resources and money.
Of course, we also test stability samples that are not stored at our premises and offer the same high standard.
A comprehensive quotation is drawn up before the start of a stability study, so that our customers always have full cost control over the entire duration.

• Preparation of testing plans/ Stability plans according to customer requirements
• Storage of samples in computer-controlled climate chambers in accordance with ICH guidelines at:
  • 5°C
  • 25°C / 60% rh
  • 30°C / 65% rh
  • 30°C / 75% rh
  • 40°C / 75% rh

Alternative climatic conditions available on request

• Continuous electronic recording of the climatic conditions and alarm systems
• Monitoring testing points and timely removal from storage
• Analysing test samples, for example:
  • Appearance, Dimensions
  • Mass, Disintegration, Resistance to crushing
  • Visible and non-visible particles
  • Water determination according to Karl Fisher or Loss on drying
  • Assay and test on impurities
  • Dissolutions as profile or limit test
• Documentation of test results according to costumer wishes
• Archiving of samples and documents

A complete stability study includes further test points such as transport stability studies (freeze-thaw), in-use stability studies or compatibility studies, which we can also carry out.

Routine pharmaceutical analysis includes testing the release of solid dosage forms such as tablets and capsules in both fast-release and sustained-release form, as well as liquid preparations in the form of suspensions.

Basket and paddle devices are available. Sampling can be carried out manually or automatically, as a release profile or endpoint measurement.

The release values are measured using HPLC-UV or UV/VIS spectrometers, according to the requirements of the method.