Contract lab following GMP and ICH guidelines as well as current monographs (USP, Ph. Eur., etc.)
Chemical testing, quality control, release analysis and more...
Comprehensive, well-documented characterization and quality control is indispensable to develop, use, or sell GMP-compliant active pharmaceutical ingredients (APIs) as well as high-quality fine chemicals.
For more than two decades, ChemCon has been a reliable service partner for innovative development, manufacturing, and analytical solutions. The main focus lies on organic and inorganic small molecules and polymers for pharmaceutical applications. Our analytical chemists support you with routine testing as well as tailor-made solutions to your analytical challenges. The extent of analyses and documentation is individually adjusted to your requirements: From purity determinations for fine chemicals to fully GMP-compliant analysis and release documentation for pharmaceutical ingredients.
We strongly believe in the benefits of a close partnership with instant and transparent communication: In project-based evaluations we determine the most suitable methods for your project. Instant communication of results assures a transparent and efficient progress. You will receive a comprehensive report from ChemCon’s quality control team. Additional GMP release documentation and certificates for your sample are available from ChemCon’s in-house quality assurance team.
ChemCon ist GMP certified, both by German authorities (EU GMP, most recently Feb. 2019) as well as the US Food and Drug Administration (FDA cGMP, most recently Nov. 2018). Certificates can be viewed upon request.
ChemCon’s team supports you with routine analysis as well as individually adjusted methods for your project:
- Characterization (spectroscopy, chromatography, mass spectrometry)
- Determination of physical and chemical properties
- Structure elucidation
- Process control and monitoring
Reliable analysis following ICH and GMP guidelines:
- Identity and purity control
- Determination of impurities
- Analysis of elemental impurities
- Microbiological control
- Stability studies
Method development and validation
In close collaboration with you we develop and validate analytical methods to current ICH Q2R guidelines.
- Method transfer
- Method development
- Establishment of methods described by monographs
Qualification and release
Adjusted to your demand we issue the required certificates.
- Pharmaceutical ingredients to international monographs
- Pharmaceutical ingredients to quality control plans
- Raw materials and intermediates
- Key staring materials for GMP production
- Reference standards (qualified)
ChemCon combines the expertise of a synthesis and analytical service provider under one roof:
- Synthesis of reference standards in top quality
- Development of, isolation, purification or enrichment of side products or impurities as reference standards
- Comprehensive analysis and qualification
- Certificate of analysis (CoA)