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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| Title: | 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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| 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] |
| Copyright of Journal of Chromatographic Science is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Engineering Source |
| FullText | Text: Availability: 0 |
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| Header | DbId: egs DbLabel: Engineering Source An: 194431458 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Development and validation of gas chromatography–mass spectrometry method for identification and quantification of selected non-intentionally added substances IN pharmaceutical formulations. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Pandya%2C+Stuti%22">Pandya, Stuti</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Vadia%2C+Nasir%22">Vadia, Nasir</searchLink><relatesTo>2</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Sheth%2C+Navin%22">Sheth, Navin</searchLink><relatesTo>1</relatesTo> (AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Journal+of+Chromatographic+Science%22">Journal of Chromatographic Science</searchLink>. May/Jun2026, Vol. 64 Issue 5, p1-7. 7p. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Gas+chromatography%2FMass+spectrometry+%28GC-MS%29%22">Gas chromatography/Mass spectrometry (GC-MS)</searchLink><br /><searchLink fieldCode="DE" term="%22Plastics+in+packaging%22">Plastics in packaging</searchLink><br /><searchLink fieldCode="DE" term="%22Pollutants%22">Pollutants</searchLink><br /><searchLink fieldCode="DE" term="%22Scientific+method%22">Scientific method</searchLink><br /><searchLink fieldCode="DE" term="%22Model+validation%22">Model validation</searchLink><br /><searchLink fieldCode="DE" term="%22Excipients%22">Excipients</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: 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] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Journal of Chromatographic Science is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1093/chromsci/bmag019 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 7 StartPage: 1 Subjects: – SubjectFull: Gas chromatography/Mass spectrometry (GC-MS) Type: general – SubjectFull: Plastics in packaging Type: general – SubjectFull: Pollutants Type: general – SubjectFull: Scientific method Type: general – SubjectFull: Model validation Type: general – SubjectFull: Excipients Type: general Titles: – TitleFull: Development and validation of gas chromatography–mass spectrometry method for identification and quantification of selected non-intentionally added substances IN pharmaceutical formulations. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Pandya, Stuti – PersonEntity: Name: NameFull: Vadia, Nasir – PersonEntity: Name: NameFull: Sheth, Navin IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 05 Text: May/Jun2026 Type: published Y: 2026 Identifiers: – Type: issn-print Value: 00219665 Numbering: – Type: volume Value: 64 – Type: issue Value: 5 Titles: – TitleFull: Journal of Chromatographic Science Type: main |
| ResultId | 1 |
