Structural Chemistry

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

• Small and Large protein molecules
• Organic compounds
• Metabolites
• Macromolecules (Polymers)
• Elemental Impurities / Trace metals
• Volatiles / Semivolatiles

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, Identification, and Quantitation by GC/MS
• Melamine analysis by GC/MS and LC/MS
• Structural characterization of protein variants and isoforms

Leading-Edge Instrumentation

• LC-MS/MS: Orbitrap Exploris 480
• LC-MS/MS Triple Quad
• GC/MS
• UPLC
• GC (FID & TCD)
• HPLC (multiple detectors)
• ICP-OES Avio 550
• ICP-MS
• Total Organic Carbon (TOC)
• Dissolution Apparatus 708-DS & Sampling Station 850-DS
• EndoToxin
• Flow Cytometer
• Qd-PCR
• DNA Analyzer & Genome Sequencer
• Freeze-Dryer (Lyophilizer)
• and many others

We provide advanced pharmaceutical product R&D, analytical chemistry and microbiology testing. we provide our services according to ISO 17025, Good Laboratory Practice (GLP), Good Manufacturing Practice (cGMP), and other standards. We perform testing protocols according to standard methodologies (ISO, 21 CFR, EU, AOAC) and are experts in developing tailored analytical methods and performing method validation for specific testing applications.