Analytical Capabilities

Over the years, Bachem has gathered an extensive know-how not only in the synthesis of active pharmaceutical ingredients, peptides as well as small molecules, but also in the analysis of these compounds. The implementation of suitable analytical methods, an experienced, well-trained staff, and state-of-the-art equipment are important prerequisites for Bachem to maintain the superior quality of its products and to meet the expectations of even the most demanding customer. Besides performing all analytical tests demanded by the regulatory authorities for the respective API we also conduct stability studies and test for interactions with packaging materials or other materials that might come into contact with the active. Our high analytical standards apply not only to our APIs but to all of our products.
 
We constantly develop and validate new analytical methods, aiming at setting industrial standards in the analysis of peptides. Currently, our products are analyzed by the following methods on a routine basis:
 

Chromatographic Techniques

• High Performance Liquid Chromatography (HPLC)
• High Performance Liquid Chromatography coupled with Mass Spectrometry (HPLC-MS)
• Ultra-High Performance Liquid Chromatography (UHPLC - available detectors: UV, CAD, RI, MALS)
• Ultra-High Performance Liquid Chromatography coupled with Mass Spectrometry (UHPLC-MS)
• 2D Ultra-High Performance Liquide Chromatography (2D-LC)
• Thin Layer Chromatography (TLC)
• Gas Chromatography (GC)
• Ion Chromatography (IC)

Spectroscopic Methods

• Electrospray Mass Spectrometry (ESI-MS Iontrap & TOF)
• Matrix Assisted Laser Desorption/Ionization Mass Spectrometry (MALDI-TOF-MS)
• Sequencing (ESI-& MALDI-MS/MS)
• Infrared Spectroscopy (IR)
• UV/VIS Spectroscopy
• Tm (UV melting curve)
• Circular Dichroism Spectroscopy (CD)
• Nuclear Magnetic Resonance Spectroscopy (1H, 13C, 31P & 19F - NMR)
• Fluorescence Spectroscopy

Other Techniques

• Amino Acid Analysis (AAA)
• Elemental Analysis (CHN)
• Enantiomer Content
• Polarimetry
• Refractometry
• Titration
• Turbidimetry
• Osmolality
• Total Organic Carbon (TOC)
• Total Viable Aerobic Counts
• Endotoxins (LAL-test)
• Heavy Metals
• Sulfated Ash
• Residue on Ignition
• Micro Flow Imaging (MFI)
• Gel Electrophoresis (Native & SDS-Page