Assessment of Volatile Component Stability in Guanxin Jieyu Granules through Gas Chromatography in Accordance with Q14 Guidelines

Assessment of Volatile Component Stability in Guanxin Jieyu Granules through Gas Chromatography in Accordance with Q14 Guidelines | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Assessment of Volatile Component Stability in Guanxin Jieyu Granules through Gas Chromatography in Accordance with Q14 Guidelines Liquan Chen, Ting Zhang, Ningji Fang, Haofang Wan, Yu He, Haitong Wan This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7318985/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 25 Dec, 2025 Read the published version in Scientific Reports → Version 1 posted 16 You are reading this latest preprint version Abstract Guanxin Jieyu Granules, a novel traditional Chinese medicine (TCM) in development, targets depression following myocardial infarction. To improve stability, its volatile oil components—including borneol—are stabilized via β-cyclodextrin inclusion. In compliance with ICH Q14 guidelines, a gas chromatography (GC) analytical method was developed, incorporating knowledge management, risk management, experimental design, and results analysis, as well as performance evaluation of the analytical method. Accelerated Destructive Degradation Tests (ADDTs) using this method revealed a dramatic stability enhancement from β-cyclodextrin encapsulation. At 25°C over 730 days, the inclusion complex showed only a 1.10% probability of failure (defined as ≥ 5% content loss), compared to 88.50% for the physical mixture. These results underscore the critical role of cyclodextrin inclusion in preserving volatile TCM constituents. Biological sciences/Drug discovery Health sciences/Medical research Experimental Design Borneol Gas Chromatography Development of Analytical Methods Accelerated Destructive Degradation Tests Full Text Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 25 Dec, 2025 Read the published version in Scientific Reports → Version 1 posted Editorial decision: Revision requested 15 Oct, 2025 Reviewers agreed at journal 08 Oct, 2025 Reviews received at journal 08 Oct, 2025 Reviews received at journal 08 Oct, 2025 Reviewers agreed at journal 06 Oct, 2025 Reviewers agreed at journal 06 Oct, 2025 Reviewers agreed at journal 05 Oct, 2025 Reviews received at journal 22 Sep, 2025 Reviewers agreed at journal 18 Sep, 2025 Reviewers agreed at journal 18 Sep, 2025 Reviewers agreed at journal 09 Sep, 2025 Reviewers invited by journal 07 Sep, 2025 Editor assigned by journal 07 Sep, 2025 Editor invited by journal 13 Aug, 2025 Submission checks completed at journal 11 Aug, 2025 First submitted to journal 11 Aug, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7318985","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":512427407,"identity":"ff5b0dba-0965-4089-92b5-2d2bc9d26297","order_by":0,"name":"Liquan Chen","email":"","orcid":"","institution":"Zhejiang Chinese Medical University","correspondingAuthor":false,"prefix":"","firstName":"Liquan","middleName":"","lastName":"Chen","suffix":""},{"id":512427408,"identity":"70bffcfa-ca3f-43b2-be3a-03819df52964","order_by":1,"name":"Ting Zhang","email":"","orcid":"","institution":"Zhejiang Chinese Medical 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To improve stability, its volatile oil components\u0026mdash;including borneol\u0026mdash;are stabilized via β-cyclodextrin inclusion. In compliance with ICH Q14 guidelines, a gas chromatography (GC) analytical method was developed, incorporating knowledge management, risk management, experimental design, and results analysis, as well as performance evaluation of the analytical method. Accelerated Destructive Degradation Tests (ADDTs) using this method revealed a dramatic stability enhancement from β-cyclodextrin encapsulation. At 25\u0026deg;C over 730 days, the inclusion complex showed only a 1.10% probability of failure (defined as \u0026ge;\u0026thinsp;5% content loss), compared to 88.50% for the physical mixture. 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