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Eurofins Scientific — AOAC 2018
28 slides from Eurofins Scientific's conference presentation, 2018
Slide 1: Eurofins
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Slide 2: Eurofins Supplement Analysis Center
Eurofins Supplement Analysis Center Bailey Ireland, Hong You, Ph.D
Slide 3: Company History
Company History Celebrating 30 Years 2004 2001 Infrastructure Eurofins Founded 2005 Global 1997 Growth Building purchase and 2017 Start Up lab expansion 1987 Infrastructure Eurofins Start Expansion Growth thru Acquisitions and up lab with 10 Expansion thru Investment in IPO in Paris. New Labs 2015 s
Slide 4: FDA Requirements
FDA Requirements Dietary Supplement Supplier/Manufacturing • Responsible for making sure their products are safe BEFORE they go to the market • Follow current Good Manufacturing Practice • Notify FDA of new ingredients • Report adverse events
Slide 5: Case Study #1 - Upgrade
Case Study #1 - Upgrade • Caffeine Reference Material to ISO 17034 Certified Reference Material
Slide 6: Case Study #1 - Upgrade
Case Study #1 - Upgrade • Caffeine – Upgraded RM – Reagent grade RM to CRM – Potential for higher quality RM • Improved measuring equipment and techniques • Reference Material Providers issue more information
Slide 7: Case Study #1 - Upgrade
Case Study #1 - Upgrade • Caffeine – Upgraded RM – Reagent grade RM to CRM – Potential for higher quality RM • Improved measuring equipment and techniques • Reference Material Providers issue more information
Slide 8: Case Study #1 - Upgrade
Case Study #1 - Upgrade • Reference Material – General Term – Can by quantitative or qualitative
Slide 9: Case Study #1 - Upgrade
Case Study #1 - Upgrade • Certified Reference Material – Characterized by valid procedures – Reference material certificate: specified properties, uncertainty, traceability – Relevant uncertainties reported
Slide 10: Case Study #2 – Checks and Balances
Case Study #2 – Checks and Balances • Hesperidin In-House Reference Material
Slide 11: Case Study #2 – Checks and Balances
Case Study #2 – Checks and Balances Bioflavonoids - HPLC-UV • Control Reference Material – Selection – Preparation • Issue: Hesperidin control results failing low
Slide 12: Case Study #2 – Checks and Balances
Case Study #2 – Checks and Balances RM Calculation Mode • Purity % calculated as HPLC Area % • Purity % calculated as HPLC % • HPLC % calculated based on calibration curve • RM inflated results in control chart • New control chart created with CRM • Consider RM quality and assay method
Slide 13: Case Study #3 – Reliable Sources
Case Study #3 – Reliable Sources • Troxerutin Investigation
Slide 14: Case Study #3 – Reliable Sources
Case Study #3 – Reliable Sources Troxerutin • High result bias in sample • Out of Specification (OOS) investigation – RM had high purity and low moisture content compared to other RM – Contacted Supplier • Samples re-tested before reporting • Vendor Evaluation for All Suppliers
Slide 15: Case Study #3 – Reliable Sources
Case Study #3 – Reliable Sources Vendor Evaluation • Quality Assurance – ISO Certification • Support – Expiration Dates – Certificate of Analysis – Assay Method – Phone and onsite support
Slide 16: Document and Report Systems
Document and Report Systems eLIMS ComLIMS Master sample workflow tool Global test catalog SharePoint Internal log tracking and alert system eJIRA Updated D4 Customer complaint and Electronic document management System Investigation System
Slide 17: Documentation
Documentation Beurofins | HPLC Multiple Reference Material Preparation Sheet FRM-474.02 Replace: FRM-474.01 [Effective date: 03/06/2017 QA Approval: ascaseaaur2 teat AOE SAS ‘Other Chemicals or Notes OMICS Exp. Gah Prop Solvent | MsOH ACN Guu) | Love rep Solvent = a Reference Material Preparation* “
Slide 18: Organizing and Storing RM
Organizing and Storing RM • Storage information located on Certificate of Analysis • Label lab performance/R&D RM • Organize by assay method/use – Subcategories: Chemical name, Method, Method Test Family
Slide 19: Case Study #4 – R&D
Case Study #4 – R&D • B12 Method Development
Slide 20: Case Study #4 – R&D
Case Study #4 – R&D Vitamin B12 • Method Development • Issue: Co-eluting peaks • Analyte Identification – RT – Spectrum
Slide 21: Case Study #4 – R&D
Case Study #4 – R&D Optimization of HPLC condition – standard mixture Seems to be the best…
Slide 22: Methylcobalamine Water extraction Phosphate buffer extraction
Methylcobalamine Water extraction Phosphate buffer extraction Methylcobalamine *
Slide 23: Reduce flow rate for better separation
Reduce flow rate for better separation * * * *
Slide 24: Case Study #5 – Solubility
Case Study #5 – Solubility • Hyaluronic Acid Method Validation
Slide 25: Case Study #5 – Reliable Sources
Case Study #5 – Reliable Sources Hyaluronic Acid-CE • Solubility Difference: – Hyaluronic acid sodium salt from rooster comb – Hyaluronic acid sodium salt from Streptococcus equi • Method validated RM • RM Changes – equivalent RM need to be evaluated
Slide 26: Case Study #6 – Calibration
Case Study #6 – Calibration • Ginger Label Claim Recovery
Slide 27: Case Study #6 – Calibration
Case Study #6 – Calibration ID Repeatability Claim Matrixces Sample form Estimated level Recovery code test result met? Ginger-HPLC-UV 251 099 Rhizome powder Rhizome dry extract Raw material Raw material 1% Total nonvolatile ginger constituents* 5% Total nonvolatile ginger 1.10% 5.18% 110% 104% Yes
Slide 28: Conclusion
Conclusion • Improving Reference Materials Quality • Quality Control • Correct RM Storage and Organization • Use RM to Identify • Source of RM Matters • Quantification Method