Chemical testing and analysis is vital for regulatory compliance as well as to understand the quality and composition of chemical substances and materials in products, industrial processes and manufacturing. Specialist industry knowledge and expertise in applying the most relevant methodology are key to successful chemical testing. Advanced analytical instrumentation or a combination of techniques is needed to solve problems or determine composition.
Synergy Bioscience offers an array of approaches and techniques to characterize drug structures and analyze their purity at every step of the development process. In addition, Synergy's integrated team approach unites our structural chemists with scientists from other departments to provide a comprehensive set of capabilities and expertise that will efficiently accelerate and strengthen the process of characterizing and identifying complex chemical and protein compounds.
Synergy has the expertise that goes beyond chemical characterizations to include a deep understanding of all facets of drug development that can impact the successful development and launch of a product. This includes experience analyzing different routes of administration, meeting regulatory requirements, solving packaging issues, and identifying potential problems in manufacturing. With in-depth academic history, diverse industry experience, and influential industry involvement, Irvine's structural chemists are unsurpassed.
Expertise with an Array of Chemical Structures
Trace metals and organics
Industry-Leading Structural Chemistry Services
• Extractables/leachables studies
• Reference standard/drug substance characterization
• Structural elucidation of target/lead compounds, and unknowns
• Synthesis and purification of impurities and degradation products
• Elemental analysis
• Amino acid analysis
• Peptide mapping
• Glycan analysis
• Enantiomeric studies
• Full NMR data interpretation
• Residual analysis in support of biotechnology-derived products
• Residual Solvent Screening by GC/MS
• Melamine analysis by GC/MS and LC/MS
• Structural characterization of protein variants and isoforms
• LC/MS/MS: Quadrupole, triple quadrupole of mass spectrometers with APCI & ESI
• GC/MS (EI and CIionization)
• GC (multiple detectors)
• HPLC (multiple detectors)
• Flame AA
We provide advanced research and testing expertise, and test to ISO 17025, Good Laboratory Practice (GLP), Good Manufacturing Practice (cGMP), REACh and other standards. We perform testing protocols according to standard methodologies (ISO, EN, BS, ASTM, DIN, etc.) and are experts in developing tailored analytical methods and performing method validation for specific testing applications.