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Analysis of Impurities in Sartan-Type Bulk Drug Substances
Angiotensin-receptor blockers (ARBs) or sartans are among the most widely used medicines for hypertension and heart failure. A lot of commotion has been raised over the problem of successive global recalls of several generic preparations of ARBs. Carcinogenic nitrosamine impurities namely NDMA, NDEA and NMBA, are detected initially in valsartan products by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) while other authorities followed closely with similar recalls.
The quality concern rises over valsartan crisis resulted in FDA scientists developing novel and sophisticated testing methods specifically designed to detect additional emerging nitrosamine impurities. One of the methods the Office of Testing and Research from FDA has developed is based on a gas chromatography-mass spectrometry (GC-MS) headspace method. The Thermo Scientific application note, Determination of Genotoxic Nitrosamines in Valsartan with Gas Chromatography and Mass Spectrometry, demonstrates the quantitative performance of Thermo Scientific™ GC-MS solutions in combination with liquid and headspace sampling techniques to determine genotoxic nitrosamines in valsartan. The results presented are compliant with the FDA standard methods for nitrosamines detection and quantification in valsartan, providing excellent flexibility and analytical performance for routine laboratory use.
Another FDA method is based on a single HRAM LC-MS method using either the Thermo ScientificTM Q ExactiveTM Hybrid Quadrupole-OrbitrapTM Mass Spectrometer or the Q ExactiveTM HF-X hybrid Quadrupole-OrbitrapTM Mass Spectrometer, which is capable of quantifying all of the six nitrosamine impurities namely NDMA, NDEA, NEIPA, NDIPA, NDBA and NMBA simultaneously.
Thermo Fisher Scientific is one of the leading manufacturers of mass spectrometry instruments and has optimized and validated these FDA methods on Thermo Scientific GCMS and LCMS systems. These analyses meet all the requirements of current regulations, sensitivity and repeatability exceeding the expected requirements of the control limits.
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The gold standard for the sensitive and specific quantitation of target compounds in high-throughput analytical laboratories. This system features multiple monitoring and scan modes as well as the triple off-axis Thermo Scientific DynaMax XR detection system. The system is equipped with either the Thermo Scientific TRACE 1300 or TRACE 1310 gas chromatograph.
- TSQ 9000 Triple Quadrupole GC-MS/MS System
Experience an unprecedented level of quantitative and qualitative GC-MS performance easily and routinely with Thermo Scientific Orbitrap GC-MS systems. Go beyond what’s possible in your lab and redefine the frontiers of GC-MS analysis.
The determination of residual solvents (organic volatile impurities) by GC headspace is an important quality control procedure in the pharmaceutical industry. Residual solvent testing is defined in accordance with the ICH1 and required by USP and Ph. Eur. ICH guidelines include maximum concentration limits for Class 1, Class 2, and Class 3 residual solvents (most to least toxic, respectively). Fisher Chemical’s GC Headspace solvents are performance tested to ensure absence of trace level ICH residual solvents.
Key Features of Fisher Chemical GC Headspace Solvents
| Residual Solvent Class | GC Headspace Solvent Suitability Specification | ICH Residual Solvent Concentration Limit |
|---|---|---|
| 1 | 1 ppm max. | 2 ppm (Benzene) |
| 2 | 10 ppm max. | 50 ppm (Methylbutyl-ketone) |
| 3 | 50 ppm max. | NA |
| Part No | Product Description | Pack Size |
|---|---|---|
| FSBW10-1 | Water, GC Headspace | 1L |
| FSBD139-1 | DMSO, Dimethyl Sulfoxide, GC Headspace | 1L |
| FSBD133-1 | DMF, N,N-Dimethylformamide, GC Headspace | 1L |
| FSBD160-1 | DMAC, N,N-Dimethylacetamide, GC Headspace | 1L |
| FSBN140-1 | NMP, N-Methyl-2-Pyrrolidone, GC Headspace | 1L |
The gold standard for the sensitive and specific quantitation of target compounds in high-throughput analytical laboratories. This system features multiple monitoring and scan modes as well as the triple off-axis Thermo Scientific DynaMax XR detection system. The system is equipped with either the Thermo Scientific TRACE 1300 or TRACE 1310 gas chromatograph.
- TSQ 9000 Triple Quadrupole GC-MS/MS System
Experience an unprecedented level of quantitative and qualitative GC-MS performance easily and routinely with Thermo Scientific Orbitrap GC-MS systems. Go beyond what’s possible in your lab and redefine the frontiers of GC-MS analysis.
The determination of residual solvents (organic volatile impurities) by GC headspace is an important quality control procedure in the pharmaceutical industry. Residual solvent testing is defined in accordance with the ICH1 and required by USP and Ph. Eur. ICH guidelines include maximum concentration limits for Class 1, Class 2, and Class 3 residual solvents (most to least toxic, respectively). Fisher Chemical’s GC Headspace solvents are performance tested to ensure absence of trace level ICH residual solvents.
Key Features of Fisher Chemical GC Headspace Solvents
| Residual Solvent Class | GC Headspace Solvent Suitability Specification | ICH Residual Solvent Concentration Limit |
|---|---|---|
| 1 | 1 ppm max. | 2 ppm (Benzene) |
| 2 | 10 ppm max. | 50 ppm (Methylbutyl-ketone) |
| 3 | 50 ppm max. | NA |
| Part No | Product Description | Pack Size |
|---|---|---|
| FSBW10-1 | Water, GC Headspace | 1L |
| FSBD139-1 | DMSO, Dimethyl Sulfoxide, GC Headspace | 1L |
| FSBD133-1 | DMF, N,N-Dimethylformamide, GC Headspace | 1L |
| FSBD160-1 | DMAC, N,N-Dimethylacetamide, GC Headspace | 1L |
| FSBN140-1 | NMP, N-Methyl-2-Pyrrolidone, GC Headspace | 1L |
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