[ COSMETICS & PERSONAL CARE ] ANALYTICAL SOLUTIONS FOR COSMETICS & PERSONAL CARE A clear path to greater product innovation, safety, and compliance

[ COSMETICS & PERSONAL CARE ] ANALYTICAL SOLUTIONS FOR COSMETICS & PERSONAL CARE A clear path to greater product innovation, safety, and compliance

2 A NEW FORMULA FOR SUCCESS

[ COSMETICS & PERSONAL CARE ] Driven by fast-moving trends and consumers unending search for novel beauty products, the personal care and cosmetics business is in constant motion. In an industry where fewer than 40% of new products succeed, the product pipeline can never be too full. To meet your growth and profitability goals, you need to continuously pursue accelerated innovation and ever-shorter product development cycles. However, there are more than a few obstacles in your way, including: Growing regulatory requirements Increased pressure to validate product performance claims Consumer demand for more natural and organic products The constant threat of competitive pressure and counterfeiting. The answer to many of these challenges can be found in the analytical laboratory and Waters solutions can provide them, every step of the way. COUNTERFEIT DETECTION 4 RAW MATERIALS TESTING 6 FORMULATION 8 SAFETY AND REGULATORY TESTING 10 QUALITY CONTROL 12 3

COUNTERFEIT DETECTION: PROTECTING YOUR BRAND INTEGRITY According to a recent European Union study, 1 counterfeiting costs the cosmetics and personal care industry $5.25 billion annually, tens of thousands of jobs, and deprives governments of $1.9 billion in tax revenues. For consumers, it s not just a matter of getting swindled. Counterfeit products may even cause physical harm, as many have been found to contain toxins and carcinogens. While luxury brands are the most frequent targets of counterfeiters, no personal care manufacturer is immune to the problem. For all of these reasons, companies need to be able to test samples to identify counterfeits quickly and confidently, but catching them requires a high volume of painstaking analytical work. Identify Counterfeit Cosmetics with Multivariate Analysis What s needed is a way to swiftly compare a suspect sample to the authentic product and determine if there are differences and if necessary, provide a more detailed analysis in order to identify the individual components. Waters fulfills this need with an approach based on fast and simple multivariate analysis combining Liquid Chromatography (LC) or Atmospheric Pressure Gas Chromatography (APGC) with advanced time-of-flight Mass Spectrometry (MS). Counterfeit Testing Solutions: ACQUITY UPLC I-Class System UNIFI Scientific Information System Xevo G2-XS QTof Mass Spectrometer Atmospheric Pressure GC (APGC) ACQUITY UPLC Columns CORTECS 1.6 µm Columns ACQUITY I-Class System with Xevo G2-XS QTof. 4 1. https://oami.europa.eu/ohimportal/en/web/observatory/quantification-of-ipr-infringement

[ COSMETICS & PERSONAL CARE ] SOLUTION KEY FEATURES & BENEFITS: The key to any Waters counterfeit testing solution is the UNIFI Scientific Information System, which includes multivariate analysis tools. These tools enable you to reduce the multivariate dimensionality of large data sets by using statistical modeling and principle components analysis (PCA). An initial summary provides guidance for any further analysis that may be required, and the resulting marker sets can be labeled as authentic or counterfeit and saved. Subsequent samples of suspected counterfeit products can then be analyzed and compared to the authentic marker set and quickly identified. -200 1400 1200 1000 800 600 400 200 0-200 -400-600 -800-1000 -1200-1400 1600-1800 -1600-1400 -1200-1000 -800-600 -400-200 0 200 400 600 800 1000 =1200 1400 1600 1800 Fake Cream Fake Lotion Fake Serum Real Cream Real Lotion Real Serum Xevo G2-XS QTof and UNIFI Scientific Information System multivariate analysis tools used for the identification of counterfeit cosmetics. With Waters, cosmetics and personal care product manufacturers now have the tools to protect their revenues, their consumers health, and their brand s integrity. ACQUITY UPLC I-Class System The most powerful binary UPLC system, engineered for the lowest dispersion. Provides rapid, high-resolution separations to help resolve components of interest from complex matrix interference peaks. Maximizes peak capacity to enhance MS sensitivity. Provides the lowest carryover, complementing MS sensitivity and extending MS linear dynamic range. Atmospheric Pressure GC (APGC) Adds GC capability to Waters most advanced MS technologies. Soft ionization means less fragmentation compared to techniques such as EI, resulting in higher sensitivity and specificity. Maximizes uptime and asset utilization changeover from UPLC to GC is quick and simple. Xevo G2-XS QTof Analyze the broadest range of compounds in the most complex samples. Combines StepWave ion optics with the XS Collision Cell, providing a significant increase in sensitivity with no reduction in selectivity. Delivers superior UPLC-compatible mass resolution, matrix-tolerant dynamic range, quantitative performance, mass accuracy, and speed of analysis simultaneously. UNIFI Scientific Information System Merges LC and high performance MS data both quadrupole and time-of-flight into a single solution. Encompasses data acquisition, processing, visualization, reporting, and configurable compliance tools within a networked laboratory environment. 5

RAW MATERIALS TESTING: ESTABLISHING ACTION AND SAFETY While the marketing department often directs the path of new cosmetic and personal care product development, it is the responsibility of analytical laboratories to source the best raw materials and active ingredients and determine their efficacy and safety. The challenge is to swiftly and thoroughly characterize each ingredient and ensure product safety. That s particularly difficult when dealing with complex botanicals and other naturally-occurring compounds. From an analytical perspective, it means identifying all components in a sample, developing its chemical fingerprint, pinpointing toxins and allergens, and verifying the presence of the active ingredient in the final product. Waters provides a wide range of technologies for screening, isolating and quantifying raw materials and active ingredients. Raw Material Testing Solutions: Prep 100q SFC System ACQUITY UPLC I-Class and H-Class Systems Atmospheric Solids Analysis Probe (ASAP) Xevo TQD Mass Spectrometer Xevo G2-XS QTof Mass Spectrometer Viridis, XBridge XP, XSelect XP, and ACQUITY UPLC Columns TruView Vials Prep 100q SFC System. Mass directed (m/z = 273, in source dimer) recovery of geraniol from orange oil with the Prep 100q SFC System. Sample recovery can be challenging by traditional preparative LC techniques due to the volatility of the compound. The use of supercritical fluid chromatography (SFC), which utilizes carbon dioxide as the primary mobile phase, enables up to 90% recovery for volatile compounds. 6

[ COSMETICS & PERSONAL CARE ] SOLUTION KEY FEATURES & BENEFITS: Case Study: Advancing the Characterization and Quality Control of Botanical Extracts with Mass Spectrometry Bio-Botanica is a leading manufacturer of 500+ quality botanical extracts. To better identify extract constituents and meet the constant demands of a fast-paced laboratory environment, the company implemented the ACQUITY UPLC H-Class System with the Xevo TQD Mass Spectrometer. Scientific and business benefits included trace-level contaminant detection, method consolidation, reducing separation times by approximately 75%, and the ability to identify novel compounds that may have unique cosmetic applications. Comprehensive characterization of botanicals with UPLC-MS/MS Prep 100q SFC System Provides high-throughput, semipreparative to preparative scale purification for higher productivity, greater flexibility, and lower costs per sample. Utilizes environmentally-friendly carbon dioxide (CO 2 ) as the primary mobile phase. Purification applications include chiral and achiral separations, impurity isolation, and natural products. Gas Liquid Separator (GLS) technology allows for more efficient fraction collection resulting in higher recovery of valuable compounds. Fully automated open-bed sample injection and fraction collection allows for the processing of hundreds of samples, or just a few. Atmospheric Solids Analysis Probe (ASAP) Streamlines workflow by enabling rapid, direct analysis of volatile and semi-volatile solid and liquid samples in seconds. Simply dip a glass capillary into the sample, place the probe into the source, and the heated nitrogen desolvation gas will vaporize the sample, with corona discharge for sample ionization. Applications include the analysis of active components, such as UV absorbers in personal care products 7

FORMULATION: ENSURING PERFORMANCE AND CHARACTERIZATION New formulations are the lifeblood of the beauty industry. To keep the product pipeline full and moving steadily, laboratory chemists need to develop formulations that consistently deliver the desired efficacy, performance, safety, texture, fragrance, appearance, and stability while also ensuring that the product packaging protects those attributes over time under a broad range of environmental conditions. To a large extent, the success of your business depends on how swiftly and efficiently you can master this process. But there are many challenges that stand in your way, including high analytical throughput, the need to validate label claims, regulatory limits, and the complexity of product samples. Waters addresses these challenges with unique liquid chromatography and mass detection technologies designed to enhance the effectiveness of your formulations laboratory. Formulation Testing Solutions: ACQUITY Arc ACQUITY QDa Detector Viridis, XBridge XP, XSelect XP, and ACQUITY UPLC Columns TruView Vials ACQUITY Arc with ACQUITY QDa Detector. 8

[ COSMETICS & PERSONAL CARE ] SOLUTION KEY FEATURES & BENEFITS: Helping to Streamline Formulations Testing With Waters ACQUITY Arc System, significant productivity gains can be realized in formulation testing by deploying a single LC platform that allows the efficient transfer, adjustment, or improvement of methods from any LC platform - while the ACQUITY QDa Detector provides valuable mass spectral data within your existing workflows. HPLC compatible: X Bridge BEH Shield RP C 18 130 A 5 µm 4.6 x 150 mm UHPLC compatible: CORTECS C 18 +, 130 A, 2.7 mm 4.6 x 150 mm A mixture of six commercial biocides used in formulated shampoo and hand creams were analyzed using the ACQUITY Arc System to evaluate the impact of both conventional HPLC and UHPLC based chromatographic separations. ACQUITY Arc offers method compatibility for HPLC and UHPLC separations to aid organizations transitioning their methods from HPLC to UHPLC. ACQUITY Arc System Quaternary-based LC system with the versatility and robustness required to bridge the gap between HPLC and UPLC while continuing to support validated assays. Delivers true plug-and-play method compatibility and the ability to switch between HPLC and UHPLC separations. ACQUITY QDa Detector Provides mass detection data at the push of a button. Pre-optimized to work with your samples, without sample-specific or user adjustments typical of traditional mass spectrometers. Quantify compounds with no UV response at levels not accessible to optical detection. Generate high-quality mass spectral data routinely and consistently with no special training or expertise. Whether you re testing for performance or characterization, Waters provides more ways to cut time and labor-intensive steps out of the process, without sacrificing scientific rigor. 9

SAFETY AND REGULATORY TESTING: MAKING COMPLIANCE ROUTINE Ensuring product safety is much more than a matter of fulfilling regulatory requirements. Your investments in product quality demonstrate a commitment to consumers health, environmental protection, and good corporate citizenship. Safety and regulatory testing also provide vital data to support label claims. The continuing success of your business depends on your ability to protect your reputation as a quality brand. At the same time, as more stringent regulations require more testing, you re under pressure to increase laboratory throughput. With the compliance burden only expected to grow you need a sure strategy to drive more efficient analyses. Having served the demanding criteria of the pharmaceutical, food, and environmental industries for decades, Waters is constantly developing innovative technologies to detect a diverse range of compounds and address ever-changing regulatory environments. Safety and Regulatory Testing Solutions: ACQUITY UPC 2 System Xevo TQD ACQUITY UPLC I-Class System Xevo G2-XS QTof Mass Spectrometer UNIFI Scientific Information System ACQUITY UPC 2 Trefoil Columns ACQUITY UPC 2 Torus Columns UPC 2 QC Reference Material ACQUITY UPC 2. With Waters, regulatory compliance becomes a checklist item, not a resource-intensive obstacle. 10

[ COSMETICS & PERSONAL CARE ] SOLUTION KEY FEATURES & BENEFITS: Faster, More Cost Effective Allergen Detection For the analysis of allergens, our solution is the UltraPerformance Convergence Chromatography (UPC 2 ) System and Xevo TQD Mass Spectrometer. The world s first Convergence Chromatography system, ACQUITY UPC 2 delivers a technology based on the principles of normal-phase LC that offers the ease-ofuse of reversed-phase LC. The Xevo TQD was created to reduce the complexity of tandem (triple) quadrupole mass spectrometry helping to ensure maximum productivity with minimal effort. ACQUITY UPC 2 System Combines the performance of UPLC with SFC to deliver faster separations and superior resolution for chiral and achiral applications. Utilizes supercritical carbon dioxide (CO 2 ) as the primary mobile phase to provide a more cost-effective and greener technology by reducing the use of organic solvents. Streamlines sample preparation workflow by eliminating evaporation and reconstitution steps. Precisely varies mobile phase strength, pressure, and temperature to fine-tune resolving power and selectivity. Allows the use of gradients across the widest polarity range. MRM chromatograms for 26 regulated cosmetic allergens in a mixed 5-ppm calibration standard using ACQUITY UPC 2 coupled with Xevo TQD. Rapidly Characterize Packaging Material Extracts Likewise, the combination of the ACQUITY UPLC I-Class System, Xevo G2-XS QTof Mass Spectrometer, and UNIFI Scientific Information System is an effective solution for the non-targeted screening of packaging extracts. This LC-MS methodology streamlines the structural elucidation process by utilizing MS E, an MS/MS technique that alternates between collecting accurate mass precursor and fragment ion information during a single analysis. This enables users to rapidly evaluate information for an unknown component (m/z) by ranking the possible elemental compositions and performing database searches for likely structures ranked based on fragmentation matching. Xevo TQD Mass Spectrometer Enables simultaneous acquisition of high quality quantitative and qualitative data from the widest range of experiments. IntelliStart Technology simplifies MS setup and routine operation with automated quantification workflow tools. Observe MRM (multiple reaction monitoring) data and full scan background data simultaneously for faster, more robust method development. RADAR Technology provides the sensitivity and selectivity to monitor for sample matrix interferences, impurities, and degradants. 11

QUALITY CONTROL: DELIVERING OPTIMAL PRODUCTION VOLUME Product success can be made or broken in production. For example, delivering a product to market can be negatively affected by poor process control or an inability to confirm label claims. With the US Food & Drug Administration and other regulatory bodies exerting greater influence on manufacturing best practices (e.g., cgmp), you need tools that enable you to continuously monitor production quality and back it up with the appropriate reports. Waters supports Quality Control needs with systems and software that are robust enough to handle high-volume production at all your facilities, from in-process monitoring to final product QC. Quality Control Testing Solutions: Empower 3 Chromatography Software ACQUITY UPLC H-Class System ACQUITY UPLC PDA Detector ACQUITY UPLC H-Class System with Photodiode Array (PDA) Detector. 12

[ COSMETICS & PERSONAL CARE ] SOLUTION KEY FEATURES & BENEFITS: Process Monitoring Make Faster Decisions Process monitoring of cosmetic and personal care additives during manufacturing requires accurate and rapid decision-making information to ensure product quality and consistency. Waters ACQUITY H-Class System, along with the ACQUITY UPLC PDA Detector, and Empower 3 Software provides a solution. The system can separate multiple structurally similar biocides and UV filter agents simultaneously in a fraction of time required for traditional HPLC and with PDA library matching and built-in advanced mathematical algorithms, each compound in the mixture can be identified and quantified. In addition, Empower 3 s Custom Calculation functionality allows the comparison of results to user/qc defined Pass/Fail criteria. The results can be automatically flagged in a standardized report helping to accelerate production workflow, as well as benefiting new product development and troubleshooting. Empower 3 Custom Field Formula. The QC Pass/Fail criteria are based on biocide content. ACQUITY UPLC H-Class System Highest resolution of any quaternary LC system. Improves laboratory efficiency by scaling methods to UPLC Technology. Simplifies and streamlines method development workflow. Future-proof labs by running existing HPLC and UHPLC methods today and transitioning to UPLC when you are ready. Empower 3 Chromatography Data Software Comprehensive control of LC, GC, MS, SFC, IC, and CE systems from a wide variety of vendors standardize on a single platform to reduce maintenance, training, and validation costs. Compliance-ready data management automates data capture and retrieval over a networked environment. Empower s QuickStart interface makes it easy to conduct targeted tasks and workflows. Empower 3 s ApexTrack provides effective detection of poorly-resolved or low-level peaks on noisy or sloping baselines. Empower Laboratory Analytics assembles and displays chromatography performance data in easy-to-view, graphical dashboards determine which improvements are needed to increase efficiency. Empower Mobile provides wireless access to Empower Software from a tablet or smart phone monitor system status, perform routine system administration tasks, and review reports. Systems and software to support high volume production, from in-process monitoring to final product QC. 13

DATA MANAGEMENT: LEVERAGING THE POWER OF INFORMATION Many of the biggest challenges facing personal care and cosmetics laboratories revolve around data capturing it, analyzing it, managing it, and reporting it accurately. Analytical data gathered from the product development process can also provide insights to guide future product development. Waters fulfills these needs with an array of software solutions that allow organizations to manage increasingly large volumes of data from a broad range of analytical techniques and make sample management and the regulatory process as efficient and error-free as possible. LIMS CAPABILITIES WITHOUT THE COMPLEXITIES NuGenesis Lab Management System Waters NuGenesis Lab Management System is a user-centric platform that uniquely combines synergistic data, workflow, and sample management capabilities to support the entire product lifecycle from development through manufacturing. KEY FEATURES/BENEFITS: NuGenesis SDMS automatically captures and catalogs data generated by instruments, scientists, and outside sources into a centralized data repository. REGULATORY COMPLIANCE SAMPLE MANAGEMENT & STABILITY TESTING WORKFLOW MANAGEMENT NuGenesis ELN allows laboratories to document observations, control procedures, and exchange information with other software solutions. NuGenesis SampleShare is a web client that automates the submission of samples to NuGenesis-based laboratories for analysis. NuGenesis Stability is a stability protocol management and testing solution that delivers productivity improvements at every step of the process. NuGenesis Connectors provide a bi-directional link between the NuGenesis Lab Management System and business systems such as SAP supporting more accurate and rapid decision-making. SCIENTIFIC SEARCH SCIENTIFIC DATA MANAGEMENT SYSTEM ELECTRONIC LABORATORY NOTEBOOK LABORATORY INVENTORIES SOFTWARE INTEGRATION 14

[ COSMETICS & PERSONAL CARE ] CONSUMABLES: DRIVING PRODUCTIVITY FROM THE START Given the diversity and complexity of cosmetic and personal care product samples, ensuring the most effective separations requires highly innovative column chemistries. Since the formation of the company in 1958, Waters has been developing leading-edge separation media designed for chromatography. Our wide range of analytical columns can simplify method development, validation, and transfer throughout your organization. LC/UPC 2 Column Technologies: ACQUITY UPLC BEH and XBridge BEH HPLC Columns are based on Waters patented organic/inorganic Hybrid Particle Technology (HPT). The second generation HPT, known as BEH Technology, combines the high-ph dissolution resistance of a polymer with the efficiency and mechanical stability of silica. The extreme ph, temperature, and mechanical stability of BEH Technology allows you to harness the full power of ph in UPLC, UHPLC, and HPLC methods development. BE ASSURED. CHOOSE WATERS GLOBAL SERVICES. Waters Global Services focuses on optimizing Waters products with superior service, support, upgrades, training, and WatersQualityParts. PROVEN SATISFACTION For 14 consecutive years, an independent quality auditing firm has ranked Waters Global Services best-in-class in providing expert technical knowledge, quick resolution of system issues, and process support. 1 1. Achievement in Customer Excellence Award, Comfirmit/CustomerSat, Inc., 2007-2014; NorthFace ScoreBoard Awards șm Omega Management Group Corporation, 2001-2006. XSelect HPLC Columns have alternate selectivities to the conventional C 18 or C 8 phases. These chemistries are also available for UPLC under the ACQUITY CSH and ACQUITY HSS product names. CORTECS Columns were developed to fulfill the promise of core-shell based chromatography phases: CORTECS 1.6 μm for maximum efficiency of UPLC separations, and CORTECS 2.7 μm for improved speed of analysis and flexibility for UHPLC and HPLC. ACQUITY UPC 2 Trefoil and Torus Column chemistries, combined with the ACQUITY UPC 2 Platform, enable separation scientists to better access normal-phase chromatography, with the ease and reliability of reversedphase chromatography. They provide the ability to handle both chiral and achiral separations with unequaled speed and unparalleled confidence. Waters Analytical Standards and Reagents A portfolio of differentiated and enabling standards, reference materials, and application solutions that provide simplified and faster workflows, along with a higher level of confidence, quality, and repeatability in your results. 15

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