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Development and validation of gas chromatography–mass spectrometry method for identification and quantification of selected non-intentionally added substances IN pharmaceutical formulations.

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Bibliographic Details
Title: Development and validation of gas chromatography–mass spectrometry method for identification and quantification of selected non-intentionally added substances IN pharmaceutical formulations.
Authors: Pandya, Stuti1 (AUTHOR), Vadia, Nasir2 (AUTHOR), Sheth, Navin1 (AUTHOR)
Source: Journal of Chromatographic Science. May/Jun2026, Vol. 64 Issue 5, p1-7. 7p.
Subjects: Gas chromatography/Mass spectrometry (GC-MS), Plastics in packaging, Pollutants, Scientific method, Model validation, Excipients
Abstract: In recent years, the government of India has banned single-use plastic, as it is more customer-friendly but poses major disadvantages, such as leaching. As impurities can be present in any source, from the raw material to the end product, and so on, these are scientifically termed extractables and leachables. To identify these types of impurities from the pharmaceutical formulation, predominantly parenteral and ophthalmic or any other products available in plastic packaging, a rapid, selective, and simultaneous method for four different analytes has been developed with the help of gas chromatography–mass spectrometry and validated completely according to International Council for Harmonization Q2(R1) guidelines. Selected extractables and leachables, namely cyclohexanone, 2,4,7,9-tetramethyl-5-decyne-4,7-diol, bis(2-ethylhexyl) sulfosuccinate sodium salt, and benzophenone, were detected by mass spectrometry and identified using the NIST17 library of the instrument. The developed method was within the range. [ABSTRACT FROM AUTHOR]
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Database: Engineering Source
Description
Abstract:In recent years, the government of India has banned single-use plastic, as it is more customer-friendly but poses major disadvantages, such as leaching. As impurities can be present in any source, from the raw material to the end product, and so on, these are scientifically termed extractables and leachables. To identify these types of impurities from the pharmaceutical formulation, predominantly parenteral and ophthalmic or any other products available in plastic packaging, a rapid, selective, and simultaneous method for four different analytes has been developed with the help of gas chromatography–mass spectrometry and validated completely according to International Council for Harmonization Q2(R1) guidelines. Selected extractables and leachables, namely cyclohexanone, 2,4,7,9-tetramethyl-5-decyne-4,7-diol, bis(2-ethylhexyl) sulfosuccinate sodium salt, and benzophenone, were detected by mass spectrometry and identified using the NIST17 library of the instrument. The developed method was within the range. [ABSTRACT FROM AUTHOR]
ISSN:00219665
DOI:10.1093/chromsci/bmag019