We offer a wide range of mass spectrometry services, including characterization of small and large molecule active pharmaceutical ingredients, degradation products, in-process impurities, extractables/leachables, and other contaminants. Our Agilent 7700 ICP-MS represents the latest advances in ICP-MS technology, as this fully redesigned for 2009 model can achieve outstanding sensitivity and specificity by substantially reducing sample matrix interference. Characterization of proteins and other large molecules and polymers can be accurately assessed with our state-of-the-art high resolution Q-ToF MS-MS equipment. Quantitative and qualitative QA/QC testing using LC/MS-MS can be performed using our triple quadrupole mass spectrometers. Our mass spectrometry instrumentation is complemented by a variety of isolation and sample preparation techniques such as microwave digestion and prep scale LC and SFC.

ADVANTAGES

• Experienced Mass Spectrometry scientists assure reliable project execution
• Seamless support of your Product Development and Manufacturing activities from integrated Physical Chemistry, Method Development and Validation, and Biotechnology teams
• Strict GMP compliance including 21 CFR Part 11 requirements

APPLICATIONS

Large molecules

• Accurate mass measurement and characterization of proteins and peptides
• Identification of proteins and analysis of protein mixtures
• Characterization of disulfide bonds/protein oxidation
• Characterization of end capping, phosphorylation, glycosylation sites and other post-translational modifications
• Protein sequencing
• Structural analysis of carbohydrates and glycolipids
• Peptide mapping of small and large proteins
• Characterization of pegylated proteins
• Detection of non-covalent protein-ligand and protein-protein complexes
• Oligonucleotide and oligosaccharide characterization
• Antibody characterization
• Identification of impurities in biomolecules

Organic Compounds

• Characterization of in-process impurities in small molecule APIs and dosage forms
• Characterization of degradation products/degradation pathways
• Characterization of small pegylated molecules
• Characterization of extractable and leachable compounds
• Identification and quantification of residual contaminants (i.e. melamines, pluronic acid, etc.)

Semi-volatiles and Volatiles

• Impurities and degradation products
• Residual solvents
• Characterization of extractable and leachable compounds

Trace Metal Analysis

• Heavy metals
• Extractables and leachables
• Arsenic, lead, mercury and other specific metal analysis
• Speck characterization, discolorations