Detection, synthesis and analysis of pharmaceutical impurities
Detection, synthesis and analysis of pharmaceutical impurities
Identifying impurities is the first step in preventing them. By elucidating the structure of impurities, it is possible to understand their formation mechanism, which can then inform industry practice around prevention or control.
For impurity identification, the components of the drug must be separated to isolate any process contaminants, degradants, or leachables alongside the active pharmaceutical ingredients (APIs).
This can be achieved using high-performance liquid chromatography-mass spectrometry (LC-MS), which provides mass information for less volatile impurities, enabling structural identification. For more volatile impurities, gas chromatography-mass spectrometry (GC-MS) is required. Following separation, nuclear magnetic resonance (NMR) spectroscopy and Fourier-transform infrared (FTIR) spectroscopy can be used to identify any impurities in the sample.
Different combinations of techniques are used on a case-by-case basis, considering the complexity of the compound and the purity requirements of the customer. ISP Standards has state-of-the-art instrumentation and highly qualified teams to ensure the highest standards throughout impurity analysis, in addition to its catalogue of fully compliant impurity standards.
ISP Standards also offers extensive analytical services for impurity identification, including quantitative and qualitative analysis, IR and NMR analysis, mass spectrometry (MS) analysis, and purity determination.
All pharmaceutical impurities/related compounds are provided with a Certificate of Analysis (CoA) along with complete characterization data like 1H-NMR, IR, MASS, HPLC Purity, etc. On request, we also provide additional data such as 13C-NMR, 13C-DEPT, HMBC-NMR, HMQC-NMR, COSY-NMR, NOESY-NMR, NOE-NMR, CHN, TGA, Water Content, Volatile Content, Potency, Assay, etc.
ISP Standards’ expertise can help ensure accurate data for even the most complex impurities.
Synthesis of impurities is a useful tool in impurity studies. By matching the spectral and chromatographic profiles for the impurity with that of the synthesized compound, its structure can be verified. The synthesized impurity can then be studied further to understand its toxicological effect, as well as its formation mechanism. This knowledge can inform regulations and be used to optimize the synthetic process and drug formulation, ensuring safe purity levels are maintained.
ISP Standards combines a highly experienced team and superior problem-solving skills with state-of-the-art analytical instrumentation to support impurity analysis. Our custom synthesis service can provide complex or commercially unavailable impurities for analysis or internal standards, and our labeled isotopes can facilitate further studies into metabolites in biological systems.
While techniques and regulations for impurity control are continually updated, impurity screening and analysis will always have a place in safeguarding therapeutics for patients around the globe. Through our products and services, we can support research into impurities to help ensure that only safe medicines reach the marketplace.
