Overview

pharm-analyt’s services cover quantitative analysis of drugs in various biological matrices, discovery and identification of metabolites and by-products and a wide range of specific applications such as protein binding, enantioselective separation or stability studies. Most of the analytical methods we use were developed in-house.

Furthermore we are used to working with sponsor-provided methods including adaption, and revision if required.

Sponsors receive full service and individual attention throughout the entire process.
All work is carried out in accordance with OECD / European Commission GLP guidelines and inspected by our Quality Assurance department.

Acquired and generated data are stored in an industry-standard, fully certified and validated electronic archive that meets European Commission and FDA (21 CFR Part 11) requirements.

Quantitative Analysis

• drugs, narcotic drugs, metabolites and endogenous substances in various biological matrices
  
• HPLC with tandem mass spectrometry-, UV- or fluorescence detection
  
• method development and validation
  
• GMP control analytics
  
• usual scale ranging from a few samples up to high throughput analysis of large studies with several hundred samples per day

Metabolite Identification

• searching for Phase I and II metabolites in biological samples (e.g. demethylation, glucuronisation or oxidation)
  
• synthesis of postulated metabolites by competent partners, comparison and confirmation using adequate techniques
  
• determination of metabolite concentration profiles

Protein Binding

• in vitro testing in human or animal plasma
  
• chiral separation methods for checking different protein binding behaviours of enantiomeric drugs
  
• dialysis as preferred method
  
• protein binding of in vivo samples

Analytical Consulting

• support in elaborating optimal solutions for analytical problems
  
• optimisation of existing analytical methods
  
• extensive experience with various different substance classes