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, itis possible to understand their formation mechanism, which can then inform industry practice aroundprevention or control.For impurity identification, the components of the drug must be separated to isolate any processcontaminants, 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. Formore volatile impurities, gas chromatography-mass spectrometry (GC-MS) is required. Followingseparation, 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 ofthe compound and the purity requirements of the customer. ISP Standards has state-of-the-artinstrumentation and highly qualified teams to ensure the highest standards throughout impurityanalysis, in addition to its catalogue of fully compliant impurity standards
ISP Standards also offers extensive analytical services for impurity identification, includingquantitative and qualitative analysis, IR and NMR analysis, mass spectrometry (MS) analysis, andpurity 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, COSYNMR, 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 andchromatographic profiles for the impurity with that of the synthesized compound, its structure can beverified. The synthesized impurity can then be studied further to understand its toxicological effect, aswell as its formation mechanism. This knowledge can inform regulations and be used to optimize thesynthetic process and drug formulation, ensuring safe purity levels are maintained.
ISP Standards combines a highly experienced team and superior problem-solving skills with stateof-the-art analytical instrumentation to support impurity analysis. Our custom synthesis service canprovide complex or commercially unavailable impurities for analysis or internal standards, and ourlabeled isotopes can facilitate further studies into metabolites in biological systems.While techniques and regulations for impurity control are continually updated, impurity screening andanalysis will always have a place in safeguarding therapeutics for patients around the globe. Throughour products and services, we can support research into impurities to help ensure that only safemedicines reach the marketplace
