Contract Analytics

As a GMP-certified and FDA-registered contract laboratory, we offer a broad spectrum of analytical services in accordance with pharmaceutical standards.
Our service portfolio includes a wide range of methods for the testing of solid and liquid pharmaceuticals according to Ph. Eur. and USP-NF, as well as the development and validation of analytical methods for release testing and stability studies.

Current Focus: Generic Methods

What does commissioning the establishment of a generic method under GMP mean?

Generic methods are internally validated methods designed for a broad range of analytes and can be extended to your specific analyte. This means the generic method has already been fully validated according to ICH guidelines (see ICH.org – Validation of Analytical Procedures Q2 (R1)). This basic validation is supplemented by analyte-specific parameters (e.g., sample solution stability). Thus, a supplementary validation is performed for your analyte without modifying the core measurement method. As a result, your establishment costs for a GMP-compliant analysis are significantly reduced.

 ♦    Nitrite determination (Griess test) using HPLC (range: ppb)

 ♦    Residual solvent determination according to ICH Q3C

 ♦    Diethylene, propyl and ethylene glycol Determination

Excerpt from Our Service Portfolio

  • Support for formulation screening and compatibility testing during product development
  • Design and execution of stability studies
  • Development or optimization of analytical methods and transfer into the regulatory environment
  • Provision of QP services (internal Qualified Person for veterinary drug products and external QP for human drug products via partner network)
  • Preliminary investigations in accordance with Good Scientific Practice (GSP)
  • Method transfer under GMP conditions (including on-site training if required)
  • Preparation of all relevant GMP documents and SOPs

A list of our available analytical methods can be found under GMP analytics:

Learn more about GMP Analytics

Cooperation with ERWEKA

Comparative measurements and method transfer:

  • Performance comparison of dissolution apparatus from different manufacturers and models
  • Preliminary studies or formal method transfer under GMP conditions
  • Experienced laboratory team provides on-site support and training if required
  • Preparation of all relevant GMP documents and SOPs

Method development and validation:

  • Complete development of dissolution methods from solubility testing and selection of apparatus type to definition of method parameters and demonstration of discriminatory power
  • Development and validation of analytical methods for dissolution evaluation (e.g., U-HPLC, photometry), including full documentation
  • Revalidation of methods following changes to method parameters (e.g., filters, sinkers, media, concentration range, formulation, etc.)
  • Feasibility assessment for transitioning manual methods to automation (including validation)
  • Optimization of dissolution methods (duration, media, robustness, etc.)
  • Troubleshooting of dissolution methods
  • Creation of test specifications and SOPs

Dissolution studies:

  • Determination of dissolution behavior for quality control and stability studies under GMP (including CoA or result report)
  • Execution of profile dissolution studies in various media / pH values
  • Bioequivalence testing via dissolution comparison of originator and comparator products (including SUPAC studies)
  • Biopharmaceutical characterization of formulations
  • Special dissolution testing: gastric resistance, buffer transitions, enzyme addition, infinity test, intrinsic dissolution, simulation media, influence of food, alcohol, stress conditions, etc.

Device support:

  • Design of customized dissolution apparatus for special dosage forms
  • Design of specific adapters
  • Adjustment and extension of relevant device parameters (temperature, volume, rotation speed, etc.)
  • Provision and execution of qualification concepts
  • On-site support by an experienced technical team