CHROMATOGRAPHIC SYSTEM SUITABILITY TESTING: INFLUENCE OF CORRECTION FACTORS AND LATE ELUTING PEAKS OF IMPURITIES ON THE REQUIREMENT FOR THE SIGNAL-TO-NOISE RATIO (REVIEW)
Introduction. In case of methods of impurities determination quite often there are problems connected both with establishment and with check of implementation of the requirement to necessary sensitivity of a chromatographic system.Text. Influence of correction factors and late eluting peaks of impur...
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| Format: | Article |
| Language: | Russian |
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LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2019-02-01
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| Series: | Разработка и регистрация лекарственных средств |
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| Online Access: | https://www.pharmjournal.ru/jour/article/view/656 |
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| _version_ | 1850047057156374528 |
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| author | N. A. Epshtein |
| author_facet | N. A. Epshtein |
| author_sort | N. A. Epshtein |
| collection | DOAJ |
| description | Introduction. In case of methods of impurities determination quite often there are problems connected both with establishment and with check of implementation of the requirement to necessary sensitivity of a chromatographic system.Text. Influence of correction factors and late eluting peaks of impurities on the requirement for the signal-to-noise ratio (S/N) for chromatographic system suitability testing is considered.Conclusion. The recommendations are provided how to detect situations at which the requirement of S/N≥10 is insufficient for reliable detecting peaks of all impurities (related substances) and therewith how to correct concentration of test solution and/or the requirement to S/N for system suitability testing. |
| format | Article |
| id | doaj-art-6e9adf92ca3a4746bc7b42d6d4e03b09 |
| institution | DOAJ |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| publishDate | 2019-02-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj-art-6e9adf92ca3a4746bc7b42d6d4e03b092025-08-20T02:54:18ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492019-02-018110811210.33380/2305-2066-2019-8-1-108-112656CHROMATOGRAPHIC SYSTEM SUITABILITY TESTING: INFLUENCE OF CORRECTION FACTORS AND LATE ELUTING PEAKS OF IMPURITIES ON THE REQUIREMENT FOR THE SIGNAL-TO-NOISE RATIO (REVIEW)N. A. Epshtein0Center of registration and development of medicines LLC «IRVIN 2»Introduction. In case of methods of impurities determination quite often there are problems connected both with establishment and with check of implementation of the requirement to necessary sensitivity of a chromatographic system.Text. Influence of correction factors and late eluting peaks of impurities on the requirement for the signal-to-noise ratio (S/N) for chromatographic system suitability testing is considered.Conclusion. The recommendations are provided how to detect situations at which the requirement of S/N≥10 is insufficient for reliable detecting peaks of all impurities (related substances) and therewith how to correct concentration of test solution and/or the requirement to S/N for system suitability testing.https://www.pharmjournal.ru/jour/article/view/656signal-to-noise ratiosystem suitabilitycorrection factorslate eluting peaksimpuritiesrelated substances |
| spellingShingle | N. A. Epshtein CHROMATOGRAPHIC SYSTEM SUITABILITY TESTING: INFLUENCE OF CORRECTION FACTORS AND LATE ELUTING PEAKS OF IMPURITIES ON THE REQUIREMENT FOR THE SIGNAL-TO-NOISE RATIO (REVIEW) Разработка и регистрация лекарственных средств signal-to-noise ratio system suitability correction factors late eluting peaks impurities related substances |
| title | CHROMATOGRAPHIC SYSTEM SUITABILITY TESTING: INFLUENCE OF CORRECTION FACTORS AND LATE ELUTING PEAKS OF IMPURITIES ON THE REQUIREMENT FOR THE SIGNAL-TO-NOISE RATIO (REVIEW) |
| title_full | CHROMATOGRAPHIC SYSTEM SUITABILITY TESTING: INFLUENCE OF CORRECTION FACTORS AND LATE ELUTING PEAKS OF IMPURITIES ON THE REQUIREMENT FOR THE SIGNAL-TO-NOISE RATIO (REVIEW) |
| title_fullStr | CHROMATOGRAPHIC SYSTEM SUITABILITY TESTING: INFLUENCE OF CORRECTION FACTORS AND LATE ELUTING PEAKS OF IMPURITIES ON THE REQUIREMENT FOR THE SIGNAL-TO-NOISE RATIO (REVIEW) |
| title_full_unstemmed | CHROMATOGRAPHIC SYSTEM SUITABILITY TESTING: INFLUENCE OF CORRECTION FACTORS AND LATE ELUTING PEAKS OF IMPURITIES ON THE REQUIREMENT FOR THE SIGNAL-TO-NOISE RATIO (REVIEW) |
| title_short | CHROMATOGRAPHIC SYSTEM SUITABILITY TESTING: INFLUENCE OF CORRECTION FACTORS AND LATE ELUTING PEAKS OF IMPURITIES ON THE REQUIREMENT FOR THE SIGNAL-TO-NOISE RATIO (REVIEW) |
| title_sort | chromatographic system suitability testing influence of correction factors and late eluting peaks of impurities on the requirement for the signal to noise ratio review |
| topic | signal-to-noise ratio system suitability correction factors late eluting peaks impurities related substances |
| url | https://www.pharmjournal.ru/jour/article/view/656 |
| work_keys_str_mv | AT naepshtein chromatographicsystemsuitabilitytestinginfluenceofcorrectionfactorsandlateelutingpeaksofimpuritiesontherequirementforthesignaltonoiseratioreview |