Competence and Progress

Analytical quality control must conform to the present and future requirements of our clients and of national and international autorithies. With exellent technical and human resources, we cover the whole spectrum of analytical services for the pharmaceutical, chemical, medical and cosmetics industries.

 

BioChem is an independent company located in Karlsruhe. Founded in 1973 and subsequently organized as an LLC in 1981, BioChem GmbH is a contract laborytory with a well established tradition of service and competence in all areas of analysis. The analytical laboratory routionely performs analytica on:

 

  • pharmaceutical products
  • chemical products
  • medical devices
  • cosmetic products
  • cytostatics

  • narcotics, etc.

 

The Complete Spectrum

BioChem`s analytical laboratory offers:

 

  • complete analytical testing
  • quality control
  • release testing
  • EU reanalysis
  • stability testing
  • storage of stability sambles
  • photostability testing
  • stress testing
  • water analyses
  • complaint investigation
  • analytical method development
  • analytical method optimization
  • analytical method validation
  • pharmacokinetics
  • literature research
  • support in registration activitied, etc.

 

All analytical activities are performed according to current GMP and GLP regulations. Non-GMP analytics for research purposes are available on request.

 

We provide analyses  according to DAB / EP, USP, BP, JP, AMG, MPG, ChemG, OECD and EC directives as well as other specific national, international or customer requirements. The analytical techniques include testing of identity, content (assay), purity,impurity, related substances and residue
using:

 

  • HPLC (High-Performance Liquid
  • Chromatography)
  • GC (Gas Chromatography)
  • AAS (Atomic Absorption Spectroscopy)
  • Dissolution
  • Titrations (visual or physical-chemical endpoint determination)
  • Karl-Fischer titration
  • UVNIS photometry
  • IR
  • thin-Iayer chromatography
  • pH, conductivity, density, viscosity,osmolality, refractive index, specific rotation
  • hardness, friability, disintegration
  • micropenetration
  • microscopic examinations
  • x-ray fluorescence analysis
  • TOC, water analyses, etc.

 

We are continually establishing new methods and frequently update our analytical equipment. Please contact us if the method you require is not listed above.

Certified Safety

Our laboratory is GMP- and GLP-certified and frequently inspected by the ofticial certifying authorities. All laboratory activities
are controlled by a dedicated quality assurance unit stafted with experienced and highly qualified laboratory specialists.

Stability Testing

We ofter long-term, intermediate, accelerated and follow-up stability studies. Storage chambers and cabinets include ICH conditions:

• 25°C / 60% r.H.
• 30°C/ 65% r.H .
• 40°C / 75% r.H.
• refrigeration conditions
• special climatic conditions on request

The storage conditions are monitored by:

• computer-controlled online systems
• SMS-connected alarm system
• daily personal controls
• 7 x 24-hour service contracts

We offer full service with complete stability management. Storage with delivery date control is possible.

Potential for Outsourcing

The analytical laboratory provides the complete range of analytical services for oll types of pharmaceutical, chemieal, medical and cosmetic sampies. In cooperation with BioChem's microbiology and experimental biology departments, we oner comprehensive and reliable services even for very complex projects. We can guarantee state-of-the-art analytical procedures, a competent client advisory service, together with prompt attention to orders at competitive
prices. If time is short, we support our clients overnight and weekends.

Competence through Experience

Our know-how and practical experience is greatly complemented by our close contacts to research communities and to the industry in Europe, the USA and Asia. Due to the ever-changing demands experienced in these collaborations, our expertise is continuously expanding. The knowledge accumulated in all areas of analytics, allows BioChem to oner competent solutions even for complex projects.