Analytical Chemistry Services
Your Global Drug Development Organization for Analytical Chemistry Testing
Delivering a product from discovery to the market is a long and often difficult process, filled with a great number of scientific, safety and regulatory challenges. From early discovery to final product release, SGS offers a broad portfolio of high quality, analytical chemistry services using advanced methods and instrumentation.
SGS provides a conveniently located network of laboratories in North America, Europe and Asia-Pacific to deliver harmonized solutions to local markets and international pharmaceutical and biotechnology firms. Our recognized experts provide effective and efficient solutions for R&D, analytical development and quality control testing, helping to expedite the molecule to market.
Reduce Costs, Increase Efficiencies and Improve Development Pipelines
Discover the full range of our analytical chemistry services.
Download brochureAnalytical Chemistry Capabilities
Method Development & Validation
- Method development for identity, assay and purity of drug products, APIs and degradation products
- Phase appropriate method validation according to ICH guidelines and/or customer requirements
- Verification of accuracy and suitability of the developed method
- Development and validation of stability indicating methods
- Analytical method transfer
- Re-development and re-validation
- Cleaning validation studies
- Method development for identity, assay and purity of drug products, APIs, degradation products and leachables
Discovery
- Identification of unknowns
- Extractable investigations
- Structural characterization
- In-vitro metabolomics
- Bio-marker screening/identification
Routine Chemistry
- Assay and purity (e.g. chromatography, titration, limit tests)
- Identity (e.g. spectroscopy, chromatography, spectrometry)
- Dissolution test (on-line/off-line)
- Pharmaceutical water analysis (e.g. TOC)
- Water content (loss on drying, KF titration)
- Disintegration
- Appearance (e.g. clarity, opalescence)
- pH and conductivity
- Pharmacopeia testing
- Osmolality, osmolarity
- Melting point, boiling point, etc.
- Viscosity, rheology
- Uniformity of mass
- Leachable analysis
Comparability
- Biopolymer sequencing
- Primary to tertiary structure characterization
- Post-translational modifications
- Bio equivalence
- Impurity profiling
Stability Testing
- Long-term stability studies
- Short-term accelerated studies
- Follow-up stabilities
- Photostability testing
- All ICH conditions and specific conditions
- Fully controlled and monitored
- All systems with 24/7 monitoring and alert system
- Validated monitoring system, 21 CFR part 11 compliant
- Back-up chambers available
- Comprehensive documentation
Applications
The network of experts at SGS have a broad range of experience in the analysis of a wide range of APIs, excipients, ancillary products, extractables, and many other chemical types used in the development of bio/pharmaceutical therapeutics.
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Why Choose SGS?
SGS is the world’s leading inspection, verification, testing and certification company. We help bio/pharmaceutical and medical device companies by providing services along the entire drug development pathway. We offer a comprehensive range of integrated solutions, including preclinical activities, Phase I-IV clinical trials, bioanalytical, pharmaceutical development, biologics characterization, biosafety, and quality control testing of small and large molecules, raw materials, containers, and finished products.
