Intra-Laboratory Validation of Alpha-Galactosidase Activity Measurement in Dietary Supplements
Introduction: Alpha-galactosidase (α-Gal) is an enzyme responsible for the hydrolyzation of glycolipids and glycoprotein commonly found in dietary sources. More than 20% of the general population suffers from abdominal pain or discomfort caused by intestinal gas and by indigested or partially digest...
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| Format: | Article |
| Language: | English |
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MDPI AG
2021-03-01
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| Series: | Molecules |
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| Online Access: | https://www.mdpi.com/1420-3049/26/6/1566 |
| _version_ | 1827697859610279936 |
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| author | Elena Fabris Michela Bulfoni Alessandro Nencioni Emanuele Nencioni |
| author_facet | Elena Fabris Michela Bulfoni Alessandro Nencioni Emanuele Nencioni |
| author_sort | Elena Fabris |
| collection | DOAJ |
| description | Introduction: Alpha-galactosidase (α-Gal) is an enzyme responsible for the hydrolyzation of glycolipids and glycoprotein commonly found in dietary sources. More than 20% of the general population suffers from abdominal pain or discomfort caused by intestinal gas and by indigested or partially digested food residuals. Therefore, α-Gal is used in dietary supplements to reduce intestinal gases and help complex food digestion. Marketed enzyme-containing dietary supplements must be produced in accordance with the Food and Drug Administration (FDA) regulations for Current Good Manufacturing Practice (cGMPs). Aim: in this work we illustrated the process used to develop and validate a spectrophotometric enzymatic assay for α-Gal activity quantification in dietary supplements. Methods: The validation workflow included an initial statistical-phase optimization of materials, reagents, and conditions, and subsequently a comparative study with another fluorimetric assay. A final validation of method performance in terms of specificity, linearity, accuracy, intermediate-precision repeatability, and system precision was then executed. Results and conclusions: The proven method achieved good performance in the quantitative determination of α-Gal activity in commercial food supplements in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals (ICH) guidelines and is suitable as a rapid in-house quality control test. |
| first_indexed | 2024-03-10T13:17:39Z |
| format | Article |
| id | doaj.art-b31556965bc341f699e8fc399152d082 |
| institution | Directory Open Access Journal |
| issn | 1420-3049 |
| language | English |
| last_indexed | 2024-03-10T13:17:39Z |
| publishDate | 2021-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Molecules |
| spelling | doaj.art-b31556965bc341f699e8fc399152d0822023-11-21T10:15:36ZengMDPI AGMolecules1420-30492021-03-01266156610.3390/molecules26061566Intra-Laboratory Validation of Alpha-Galactosidase Activity Measurement in Dietary SupplementsElena Fabris0Michela Bulfoni1Alessandro Nencioni2Emanuele Nencioni3Biofarma Group Srl, Via Castelliere 2, Mereto di Tomba, 33036 Udine, ItalyInstitute of Pathology Department of Medicine, University of Udine, 33100 Udine, ItalyIBSA Institut Biochimique SA, Via del Piano29, CH-6915 Pambio Noranco, SwitzerlandBiofarma Group Srl, Via Castelliere 2, Mereto di Tomba, 33036 Udine, ItalyIntroduction: Alpha-galactosidase (α-Gal) is an enzyme responsible for the hydrolyzation of glycolipids and glycoprotein commonly found in dietary sources. More than 20% of the general population suffers from abdominal pain or discomfort caused by intestinal gas and by indigested or partially digested food residuals. Therefore, α-Gal is used in dietary supplements to reduce intestinal gases and help complex food digestion. Marketed enzyme-containing dietary supplements must be produced in accordance with the Food and Drug Administration (FDA) regulations for Current Good Manufacturing Practice (cGMPs). Aim: in this work we illustrated the process used to develop and validate a spectrophotometric enzymatic assay for α-Gal activity quantification in dietary supplements. Methods: The validation workflow included an initial statistical-phase optimization of materials, reagents, and conditions, and subsequently a comparative study with another fluorimetric assay. A final validation of method performance in terms of specificity, linearity, accuracy, intermediate-precision repeatability, and system precision was then executed. Results and conclusions: The proven method achieved good performance in the quantitative determination of α-Gal activity in commercial food supplements in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals (ICH) guidelines and is suitable as a rapid in-house quality control test.https://www.mdpi.com/1420-3049/26/6/1566dietary supplementsalpha-galactosidasequality controlspectrophotometric assaymethod validation |
| spellingShingle | Elena Fabris Michela Bulfoni Alessandro Nencioni Emanuele Nencioni Intra-Laboratory Validation of Alpha-Galactosidase Activity Measurement in Dietary Supplements Molecules dietary supplements alpha-galactosidase quality control spectrophotometric assay method validation |
| title | Intra-Laboratory Validation of Alpha-Galactosidase Activity Measurement in Dietary Supplements |
| title_full | Intra-Laboratory Validation of Alpha-Galactosidase Activity Measurement in Dietary Supplements |
| title_fullStr | Intra-Laboratory Validation of Alpha-Galactosidase Activity Measurement in Dietary Supplements |
| title_full_unstemmed | Intra-Laboratory Validation of Alpha-Galactosidase Activity Measurement in Dietary Supplements |
| title_short | Intra-Laboratory Validation of Alpha-Galactosidase Activity Measurement in Dietary Supplements |
| title_sort | intra laboratory validation of alpha galactosidase activity measurement in dietary supplements |
| topic | dietary supplements alpha-galactosidase quality control spectrophotometric assay method validation |
| url | https://www.mdpi.com/1420-3049/26/6/1566 |
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