Identification and Characterization of a New Process Related Impurity in Terbutaline Sulfate by Accurate-Mass Q-TOF LC/MS/MS and NMR

Patil, Santosh; Kantikar, Gajanan; Koppula, Santhosh; Koppula, Poonam

doi:10.1007/s10337-021-04021-2

Cited by 2 publications

(1 citation statement)

References 18 publications

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“…NMR is required to further characterize the impurities. 72 Mass spectroscopy fragment information can be clarified through many databases, 73 but there is no comprehensive mass spectroscopy fragment database for impurity research.…”

Section: Mass Spectroscopymentioning

confidence: 99%

Research progress on the impurities identification and determination in pharmaceuticals

Chen

Zhang

et al. 2023

Preprint

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Rationale: Impurities refer to any substances that affect the purity of pharmaceuticals. Controlling impurities has always been a significant concern during drug development. Impurities impact the drug’s purity, diminish the efficacy of pharmaceuticals, and alter their appearance, physical, and chemical properties. Additionally, impurities can compromise the stability of pharmaceuticals and elevate their toxic and side effects. Methods: Impurity source analysis is the basis of drug impurity control. To clarify the source of impurity can optimize the synthesis process, prescription process, packaging and storage conditions of the pharmaceuticals, and control the impurity within a reasonable limit to achieve the ultimate goal of impurity research. Results: Analysis method is a means to obtain impurity information, and diversified analysis methods are also possible for effective control of different types of impurities. At present, there are relatively many quantitative studies on impurities, but there are still some challenges for the structure analysis of impurities, especially trace impurities. Conclusion: The research progress of drug impurity control and evaluation from the sources of various drug impurities and impurity analysis techniques was reviewed in this article, with the aim of providing references for the related research.

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Section: Mass Spectroscopymentioning

confidence: 99%

Research progress on the impurities identification and determination in pharmaceuticals

Chen

Zhang

et al. 2023

Preprint

View full text Add to dashboard Cite

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Significance of Chromatographic Techniques in Pharmaceutical Analysis

2022

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This work presents an overview of the modern approaches embracing advanced equipment and validation parameters of both liquid and gas chromatography techniques, including thin-layer chromatography (TLC), column liquid chromatography (CLC), and gas chromatography (GC), suitable for the identification and quantitative determination of various bioactive compounds occurring in pharmaceutical products and medicinal plants in the time from 2020 to 2021 (November). This review confirmed that HPLC is an incredibly universal tool, especially when combined with different detectors, such as UV-Visible spectroscopy, mass spectrometry (MS), and fluorescence detection for numerous active ingredients in different pharmaceutical formulations without interferences from other excipients. TLC, in combination with densitometry, is a very efficient tool for the determination of biologically active substances present in pharmaceutical preparations. In addition, TLC coupled to densitometry and mass spectrometry could be suitable for preliminary screening and determination of the biological activity (e.g., antioxidant properties, thin layer chromatography (TLC) by 2,2-diphenyl-1-picrylhydrazyl (DPPH) method) of plant materials. Gas chromatography, coupled with a mass spectrometer (GC-MS, GC-MS/MS), is of particular importance in the testing of any volatile substances, such as essential oils. LC, coupled to NMR and MS, is the best solution for identifying and studying the structure of unknown components from plant extracts, as well as degradation products (DPs). Thanks to size-exclusion chromatography, coupled to multi-angle light scattering, the quality control of biological pharmaceuticals is possible.

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Identification and Characterization of a New Process Related Impurity in Terbutaline Sulfate by Accurate-Mass Q-TOF LC/MS/MS and NMR

Cited by 2 publications

References 18 publications

Research progress on the impurities identification and determination in pharmaceuticals

Research progress on the impurities identification and determination in pharmaceuticals

Significance of Chromatographic Techniques in Pharmaceutical Analysis

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