Issue 5 • 2015 Riedel-de Haën® Kromega® Certified Reference Materials by Jaytee® pg. 3 HPLC Instrument Calibration Phytochemical Standards Marine Biotoxin CRMs Carotenoid Standards Glucuronide Drug Testing BAM-Certified Reference Materials High-Quality HPLC Buffers Water Monitoring in Cosmetics Feature Article Sigma-Aldrich®’s Collaboration – Quality and Trust 3 Kromega® Certified Reference Materials by Jaytee® Now Available at Sigma-Aldrich® Dr. Magdalena Ulman Standards 5 Phytochemical Standards New Products and New Brochure Available Dear Reader, 6 Marine Biotoxin CRMs Products from the National Research Council of Canada (NRC) Sigma-Aldrich® works continually to develop long-term Now Available through Sigma-Aldrich® relationships with suppliers who demonstrate excellent and consistent product quality. This includes not only reagents 8 Isomeric Distribution of Astaxanthin and standards, but also consumables needed for different analytical techniques. New Standards for all-trans, 9-cis and 13-cis Astaxanthin Our partners, such as Hellma® or Specac®, have already proven their outstanding 12 Traceability Means Reliability performance level and consulting experience in the areas of UV/VIS, fluorescence New Organic TraceCERT® CRMs for Chromatography and IR spectroscopy. This issue presents one of our newest important partners, who 14 Glucuronide Drug Testing Applications deliver innovative products and dependable service. by Mass Spectrometry Jaytee® is well respected among the UK’s largest pharmaceutical and chemical companies Certified Spiking Solutions® of Glucuronides as a quality lead supplier and service provider. The kromega range of Qualification Labware Standards for HPLC and UV Spectrophotometers is designed to provide you with a solid foundation for your HPLC and UV spectrophotometer instrumentation qualification. 16 New Hellma® TrayCell™ – Photometric Micro Volume Analysis in the Nanoliter Range The feature article in this issue focuses on Jaytee’s kromega standards and gives insight DNA/RNA – Simply Analyzed into this high-quality product group. 17 Timestrip® – The Smart Way to Measure Time and Temperature Kind regards, Chromatography 19 Reversed-phase HPLC Buffers High-quality Buffers (Solutions, Solids or Concentrates) Titration Dr. Magdalena Ulman Product Manager Analytical Reagents 21 Water Determination in Cosmetic Products [email protected] Karl Fischer Titration with Hydranal® Reagents Analytix is published five times per year by Sigma-Aldrich Chemie GmbH, Industriestrasse 25, CH-9471 Buchs SG, Switzerland Publisher: Sigma-Aldrich Marketing Operations Europe Publication Manager: Michael Jeitziner Editor: Daniel Vogler sigma-aldrich.com/analytix 2 Back to Table of Contents Feature Article 3 Kromega® Certified Reference Materials by Jaytee® Now Available at Sigma-Aldrich® Paul Boother, Operations Manager Regulatory [email protected] Any laboratory using analytical instrumentation is required to provide Magdalena Ulman, Product Manager Analytical Reagents [email protected] a form of instrument calibration as proof the hardware is operating correctly. The USP has a monograph [1] which defines how the equipment qualification process can be managed. The EDQM has published guidelines [2] on the suitable qualification tests for both HPLC and GC, while the EP has a monograph [3] devoted to the qualification of UV-visible spectrophotometers. In addition, the FDA requires that any instrument qualification should be based upon the needs of the user, not on the claims of the manufacturer. This suggests that it is wise to periodically check the performance of the instrument. Jaytee’s experience in supporting highly regulated customers has resulted in countless audits of our qualification services by inspectors from the FDA and MHRA, as well as by the quality departments of numerous blue chip pharmaceutical companies. This has allowed us to fine-tune the kromega CRMs to be a repeatable, reliable product which is quickly becoming the industry standard for qualification. In addition, analysts can be assured that their Introduction instrumentation is operating correctly when it successfully passes user-defined acceptance criteria using the kromega CRMs. This Reliable measurement is the basis for all analytical techniques. is because the kromega range is independently produced and Analysts spend a vast amount of time validating methods, running therefore gives a valuable “second opinion” rather than relying on system suitability tests and performing QC checks. All this is based on using the manufacturer’s non-accredited standard, analyzed with the the rationale that the instrument must be working correctly because manufacturer’s software and passing the manufacturer’s criteria. all of the above was successful, but what if the instrument itself was faulty? The truth is that many methods are developed using instrumentation which has not been proven to work correctly since the time it was installed in the laboratory. Jaytee has almost 30 years of experience supporting analytical science and has grown along with the highly regulated industries, such as pharmaceuticals and biotechnology, to deliver high quality instrument qualification services. Jaytee is now the only company in the world accredited by UKAS to IEC – ISO 17025 for the calibration of HPLC, GC and UV/visible spectrophotometers. In order to achieve this, Jaytee developed the kromega Certified Reference Material (CRM) range which provides the CRMs required to measure critical instrument parameters, thereby demonstrating that the instruments are operating to the level required by the laboratory. This range is accredited to ISO Guide 34 by UKAS, and is therefore the “Gold Standard” of Certified Reference Materials, being of the same standing as the renowned Sigma-Aldrich TraceCERT® range of CRMs. Not only do the kromega CRMs have a higher level of accreditation than any of the instrument manufacturers, but they are also suitable for cross-platform use, allowing a baseline of testing between the various OEMs. This means analysts can be assured of the level of accuracy of both their new UHPLC and the 15 year old HPLC residing in the same laboratory. 3 Back to Table of Contents 4 Analytix | 5: 2015 Data Quality Triangle The Kromega Product Range The USP monograph [1] discusses the need for data quality to be The current product range covers a variety of HPLC (or UHPLC) CRMs underpinned at every level, as demonstrated in the Data Quality suitable for calibrating systems with any style of UV detection (e.g., Triangle. The concept is simple in that lower levels of the triangle must MWD, DAD, PDA, etc.) and a range of UV/Visible Spectroscopy CRMs, be complete, otherwise anything above is questionable. To explain, which meet the European Pharmacopeia’s requirements for the if the HPLC detector wavelength is inaccurate or the autosampler calibration of UV/Vis spectrophotometers. is injecting half the expected volume, then any method validation Future additions to the range will include GC FID and other will be flawed as the conclusions will be based on inaccurate results. HPLC detectors. It follows that the system suitability will also be inaccurate and any quality control samples worthless. Unfortunately, it is also likely that Kromega CRMs for HPLC: any subsequent method transfer will then be problematic even when trying to move to an instrument of identical configuration. Part Number Description Z803898 HPLC Autosampler If the instrument were then serviced and the issue inadvertently fixed, Z804002 UV Absorbance Linearity the method may no longer perform as it did previously because the results would then be accurate. It may exhibit increased or decreased Z804126 UV Low Wavelength absorbance values which may well be outside the validated range of Z804223 UV Multi Wavelength the method. Z804339 HPLC Qualification Kit Kromega CRMs for UV/Visible Spectrophotometers: Part Number Description Z804452 UV Photometric Accuracy Z804568 UV Resolution (EP) Z804665 UV Stray Light (EP) Z804789 UV Spec Qualification Kit If you would like to obtain further information about kromega CRMs available at Sigma-Aldrich, please visit sigma-aldrich.com/jaytee References [1] USP <1058> Analytical Instrument Qualification. [2] EDQM PA/PH/OMCL (11) 04, Qualification of Equipment, Annex 1: Qualification of HPLC Equipment. [3] European Pharmacopeia 2.2.25 Absorption Spectrophotometry, Ultraviolet and Visible. sigma-aldrich.com/analytixsigma-aldrich.com/jaytee 4 Back to Table of Contents FeatureStandards Article 5 Phytochemical Standards New Products and New Brochure Available Matthias Nold, Product Manager Analytical Standards Cat. No. Description Package Size [email protected] 44787 Aconitine 10 mg 55659 Aspidinol 10 mg 72795 Butein 10 mg 61221 Castalagin 10 mg 40820 Chebulinic acid 10 mg 39273 Coptisin chloride 10 mg 43046 Cyanidin 3-sambubioside chloride 5 mg 42739 Cyanidin 3-sophoroside chloride 5mg 56523 Cycloolivil 10 mg 42575 Dehydrocostus lactone 10 mg 42883 Delphinidin 3-sambubioside chloride 5 mg 52559 Eupatorin 10 mg 94334 Formononetin 50 mg 42924 Germacrone 10 mg 89960 Ginkgotoxin 10 mg 94381 Ginsenoside R0 10 mg 44987 Ginsenoside Rc 5 mg 43019 Ginsenoside Rg6 5 mg Pharmaceutical products of plant origin, so called herbal medicinal 43084 Ginsenoside Rh3 5 mg products, enjoy great popularity as an alternative or complement to 42754 Ginsenoside Rk1 5 mg synthetic drugs. 43534 Glycitein 10 mg As the composition of a plant may vary depending on the time and 94821 Guaiaverin