Raw Materials and Excipients Testing

Raw Materials and Excipients Testing

Simplify testing of raw materials and excipients with Waters' compliance-ready solutions and expert support. Identify contamination risks, detect degradation, and confidently verify material quality to help ensure product safety and effectiveness.

Simplify testing of raw materials and excipients with Waters' compliance-ready solutions and expert support. Identify contamination risks, detect degradation, and confidently verify material quality to help ensure product safety and effectiveness.

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Overview

Excipients are inactive ingredients included in pharmaceutical formulations to enhance the drug’s stability and performance and are part of the final drug product. Their quality assessment and control are crucial. If excipients or raw materials lack quality or are contaminated, drug safety and effectiveness can be compromised, resulting in patient harm.

From characterization, impurity analysis, and release testing to stability analysis and more, Waters integrated systems, software, columns, and expert support help overcome detection limitations in excipients and raw materials analysis. Through every stage of testing— assay and composition analysis, stability and impurity analysis, and release testing— Waters solutions help you identify contamination risks and understand degradation sources, ensuring the highest standards in product quality control and safety.


Applications

Nucleic acid-based therapeutics and vaccines are rapidly emerging as powerful new modalities in modern medicine. Lipid nanoparticles (LNP) have been used with high efficacy as delivery vehicles for these advanced therapies. Waters provides comprehensive solutions from early discovery and characterization to final manufacturing quality control including raw materials analysis, composition analysis, impurities identification, and routine monitoring and testing of lipid nanoparticles.

Nucleic acid-based therapeutics and vaccines are rapidly emerging as powerful new modalities in modern medicine. Lipid nanoparticles (LNP) have been used with high efficacy as delivery vehicles for these advanced therapies. Waters provides comprehensive solutions from early discovery and characterization to final manufacturing quality control including raw materials analysis, composition analysis, impurities identification, and routine monitoring and testing of lipid nanoparticles.


Application Notes

Application Notes

Polysorbates are non-ionic surfactants widely used as excipients or inactive ingredients in both pharmaceutical and food products. Ensuring the quality and purity of excipients is essential to the safety and efficacy of the final products. Waters provides comprehensive solutions for routine analysis, quality control, and composition analysis, as well as the testing of degradants and impurities of polysorbates.

Polysorbates are non-ionic surfactants widely used as excipients or inactive ingredients in both pharmaceutical and food products. Ensuring the quality and purity of excipients is essential to the safety and efficacy of the final products. Waters provides comprehensive solutions for routine analysis, quality control, and composition analysis, as well as the testing of degradants and impurities of polysorbates.


Application Notes

Application Notes

The molecular weight distribution (MWD) of polymeric excipients critically affects their physicochemical properties and drug delivery performance. Waters integrated solutions include advanced separation systems, refractive index (RI) detection, a strong solvent compatibility kit, and Empower 3 Software with the GPC option that enables precise MWD analysis and degradation monitoring to ensure product consistency, performance, and regulatory compliance.

The molecular weight distribution (MWD) of polymeric excipients critically affects their physicochemical properties and drug delivery performance. Waters integrated solutions include advanced separation systems, refractive index (RI) detection, a strong solvent compatibility kit, and Empower 3 Software with the GPC option that enables precise MWD analysis and degradation monitoring to ensure product consistency, performance, and regulatory compliance.


Application Notes

Application Notes

Sorbitan monooleate, sorbitan sesquioleate, and sorbitan monostearate are non-ionic surfactants commonly used as excipients in pharmaceuticals, cosmetics, food, and household products to stabilize oil-in-water emulsions, enhance product texture, appearance, and spreadability.

The Waters Arc HPLC System, equipped with a strong solvent compatibility kit and refractive index (RI) detector, was successfully used to implement the proposed USP monographs for these compounds. The system demonstrated compliance with all USP requirements for system suitability and acceptance criteria for assay and organic impurities testing.

Sorbitan monooleate, sorbitan sesquioleate, and sorbitan monostearate are non-ionic surfactants commonly used as excipients in pharmaceuticals, cosmetics, food, and household products to stabilize oil-in-water emulsions, enhance product texture, appearance, and spreadability.

The Waters Arc HPLC System, equipped with a strong solvent compatibility kit and refractive index (RI) detector, was successfully used to implement the proposed USP monographs for these compounds. The system demonstrated compliance with all USP requirements for system suitability and acceptance criteria for assay and organic impurities testing.



Application Notes

Application Notes


Video: Analytical Solutions for Cosmetics and Personal Care

Cosmetics and personal care manufacturers face increasing pressure to validate product performance claims and ensure their authenticity, quality, and safety. Waters differentiated technologies are designed to address the key steps in the cosmetics and personal care analytical workflow, including counterfeit detection, raw materials testing, formulations, safety testing, and quality control. Manufacturers have tools to protect their revenues, consumer health, and brand integrity, giving them the edge to successfully compete.

Cosmetics and personal care manufacturers face increasing pressure to validate product performance claims and ensure their authenticity, quality, and safety. Waters differentiated technologies are designed to address the key steps in the cosmetics and personal care analytical workflow, including counterfeit detection, raw materials testing, formulations, safety testing, and quality control. Manufacturers have tools to protect their revenues, consumer health, and brand integrity, giving them the edge to successfully compete.


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Solutions


With Waters systems, characterize excipients and raw materials in product samples in less time and with greater confidence.

With Waters systems, characterize excipients and raw materials in product samples in less time and with greater confidence.

See clearly and consistently, with confidence

See clearly and consistently, with confidence

Produce reliable, and reproducible data from the first injection with the Arc Premier System featuring MaxPeak High Performance Surfaces (HPS) Technology to reduce non-specific adsorption due to metal interaction — without complicated mobile phases or laborious methods.

  • Polysorbates, Related Impurities, and Degradants

The next evolution in separation science is here

The next evolution in separation science is here

Minimize metal-sensitive analyte loss and improve recovery with the ACQUITY Premier System for a step change in chromatographic performance, lab efficiency, and risk control.

  • Lipid Nanoparticles Components and Impurities
  • Polysorbates, Related Impurities, and Degradants

Highly reliable, low complexity, accurate routine analysis for all

Highly reliable, low complexity, accurate routine analysis for all

Achieve high-efficiency separations and reliable data to meet regulatory requirements with the Arc HPLC System. When combined with Waters strong solvent compatibility kit, the Arc HPLC System is ideal for GPC applications.

  • Polysorbates, Related Impurities, and Degradants
  • GPC Testing for Sorbitan Esters (Non-Ionic Surfactant)

The highest performance for polymers and oligomers

The highest performance for polymers and oligomers

Perform polymer and oligomer analysis faster with the ACQUITY Advanced Polymer Chromatography (APC) System that overcomes ionic interaction and yields improved molecular weight information.

  • Molecular Weight Analysis of Polymeric Excipients

Waters high-performance LC-MS solutions for routine analysis are easy to use and maintain and can be deployed in both regulated and non-regulated environments.

Waters high-performance LC-MS solutions for routine analysis are easy to use and maintain and can be deployed in both regulated and non-regulated environments.

Compliant-ready routine monitoring in biopharmaceutical process and product development

Compliant-ready routine monitoring in biopharmaceutical process and product development

Simplify high-performance LC-MS analysis for every user using Waters BioAccord LC-MS System with ACQUITY Premier, an integrated, compliant-ready platform that can be deployed from discovery to GxP labs​.

  • Lipid Nanoparticles Components and Impurities

Waters UPLC/UHPLC and HPLC detectors, light scattering, and mass detectors allow you to analyze a wide variety of compounds to match your separation scale.

Waters UPLC/UHPLC and HPLC detectors, light scattering, and mass detectors allow you to analyze a wide variety of compounds to match your separation scale.

Putting confidence in your detection strategy

Putting confidence in your detection strategy

Detect semi- and non-volatile compounds with minimal UV absorbance with Waters 2424 Evaporative Light Scattering (ELS) Detector that offers a compact and innovative design and is compatible with both isocratic and gradient separations to increase peak detection confidence.

  • Lipid Nanoparticles Components and Impurities
  • Polysorbates, Related Impurities, and Degradants

Reliable, repeatable analysis of non-absorbing components

Reliable, repeatable analysis of non-absorbing components

Detect components without UV chromophores and achieve highly reproducible detection with a wide linear dynamic range with the 2414 RI Detector. Attain stable thermal control with temperature equilibration of incoming solvent and a thermally isolated optics bench.

  • Molecular Weight Analysis of Polymeric Excipients
  • GPC Testing for Sorbitan Esters (Non-Ionic Surfactant)

Separate beyond question with the power of mass detection

Separate beyond question with the power of mass detection

Take single quadrupole performance to the next level with the ACQUITY QDa II Mass Detector that is easy to use, remarkably robust, and complementary to optical detection to confirm and monitor raw materials and excipients.

  • Lipid Nanoparticles Components and Impurities
  • Polysorbates, Related Impurities, and Degradants

Optimize UV detection for UPLC/UHPLC separations

Optimize UV detection for UPLC/UHPLC separations

Optimize linearity, resolution, and sensitivity with ACQUITY Premier and ACQUITY UPLC Tunable UV Detectors, dual-wavelength ultraviolet/visible detectors for use with UPLC/UHPLC separations.

  • Polysorbates, Related Impurities, and Degradants

Waters software streamlines data acquisition, processing, and reporting excipients and raw materials testing results.

Waters software streamlines data acquisition, processing, and reporting excipients and raw materials testing results.

Simplify data acquisition, processing, and reporting

Simplify data acquisition, processing, and reporting

Equip your lab with Empower Chromatography Data System (CDS) and gain advanced laboratory data management for your excipients and raw materials analyses, including acquisition, processing, and reporting for liquid and gas chromatography instruments.

  • Polysorbates, Related Impurities, and Degradants
  • GPC Testing for Sorbitan Esters (Non-Ionic Surfactant)

Delivering connected science for your lab evolution

Delivering connected science for your lab evolution

Optimize workflows across a range of LC and LC-MS instruments and applications — quantitation, biopharmaceutical, and other accurate mass-based analyses, with waters_connect, a single platform to improve efficiency and reproducibility while reducing manual errors.

  • Lipid Nanoparticles Components and Impurities

Quality consumables to support your testing success.

Quality consumables to support your testing success.

Rugged, reproducible, and ultra-fast

Rugged, reproducible, and ultra-fast

Maximize selectivity and sensitivity with Oasis MAX Online Column for extracting acidic compounds with anion-exchange groups, designed to be used with the appropriate Waters narrow-bore analytical column such as the XSelect, XBridge, and SunFire columns.

  • Polysorbates, Related Impurities, and Degradants
  • Molecular Weight Analysis of Polymeric Excipients

Achieve unmatched reproducibility with a wide range of selectivity

Achieve unmatched reproducibility with a wide range of selectivity

ACQUITY Premier CSH Phenyl-Hexyl Columns are used to provide alternative analyte selectivity and are a valuable tool for method development. The trifunctionally bonded C6 phenyl ligand is a robust, low bleed sorbents that selectively retains polyaromatic compounds through pi-pi interactions. MaxPeak High Performance Surface hardware technology significantly reduces unwanted analyte/surface interactions that can lead to poor peak shape and losses in signal intensity.

  • Lipid Nanoparticles Components and Impurities

Achieve unmatched reproducibility with a wide range of selectivity

Achieve unmatched reproducibility with a wide range of selectivity

ACQUITY Premier CSH C18 Columns overcome peak shape asymmetry and poor loading capacity for basic compounds when using low ionic strength mobile phase. The surface charge enables fast column equilibration when switching from low to high pH mobile phases. MaxPeak High Performance Surface hardware technology significantly reduces unwanted analyte/surface interactions that can lead to poor peak shape and losses in signal intensity.

  • Lipid Nanoparticles Components and Impurities

Particle stability and performance for methods development

Particle stability and performance for methods development

This column comes equipped with an electronic eConnect column tag containing unique column-specific information. These NFC-enabled device-tagged columns were developed to automatically identify, track and digitally trace column use history. eConnect columns can be used on any HPLC, but its advantages are unlocked when used with the Waters Alliance iS System running Empower software.

  • Polysorbates, Related Impurities, and Degradants

Particle stability and performance for methods development

Particle stability and performance for methods development

The ACQUITY UPLC Protein BEH C4, 300 Å, 1.7 µm, 2.1 mm x 50 mm column is QC tested and optimized to separate proteins based on size, hydrophobicity and isoelectric point. If you compare to traditional C18 phases, the C4 ligand is less retentive and will minimize protein carryover, increase protein recovery, and improve peak capacity.

  • Polysorbates, Related Impurities, and Degradants

Achieve superior speed and resolution for polymer characterization

Achieve superior speed and resolution for polymer characterization

ACQUITY APC XT columns are optimized to provide highly efficient size-based separations for organic solvent soluble polymer characterization. The sorbent uses patented Ethylene Bridge Hybrid (BEH) technology to provide a mechanical strong packed bed that resists shinking and swelling for easy mobile phase solvent switching.The expected molecular weight range for this column is approximatley 1,000–30,000 g/mole.

  • Molecular Weight Analysis of Polymeric Excipients

Organic-and aqueous-based size separations

Organic-and aqueous-based size separations

Designed particularly for low molecular weight samples, where high resolution is critical. Packed with rigid 5 µm particles, these columns deliver unrivaled resolution and efficiency in the low-to-mid molecular weight range.Ideal for the analysis of oligomers, epoxies, polymer additives, phenolics, unsaturated polyester, urea/formaldehyde, polyethylene glycol, ethanolamines, and melamine resin.

  • Molecular Weight Analysis of Polymeric Excipients
  • GPC Testing for Sorbitan Esters (Non-Ionic Surfactant)

Meet your analytical challenges with the right vial

Meet your analytical challenges with the right vial

All Waters sample vials are held to the tightest dimensional tolerances. Manufactured via a 2-, 3-, or 4-step certification process, we ensure that Waters Certified Vials meet and maintain specified vial dimensions, levels of cleanliness and adsorption properties from batch to batch. Find the right vial for your application and autosampler below or use our Vial Selector to find your perfect match.

  • Lipid Nanoparticles Components and Impurities
  • Polysorbates, Related Impurities, and Degradants
  • Molecular Weight Analysis of Polymeric Excipients
  • GPC Testing for Sorbitan Esters (Non-Ionic Surfactant)

Achieve testing efficiencies and accurate results using streamlined Waters services and support.

Achieve testing efficiencies and accurate results using streamlined Waters services and support.

Your success is just a click away

Your success is just a click away

Optimize your laboratory's productivity and success with Waters Global Services. Maintain peak system performance, minimize down time, address application challenges, and support stringent compliance requirements.

  • Lipid Nanoparticles Components and Impurities
  • GPC Testing for Sorbitan Esters (Non-Ionic Surfactant)
  • Molecular Weight Analysis of Polymeric Excipients
  • Polysorbates, Related Impurities, and Degradants

Make science more accessible

Make science more accessible

Maximize resources and minimize risk with payment options from Waters Capital, including upgrading aging equipment, getting customized support, and bundling services into one monthly payment.

  • Lipid Nanoparticles Components and Impurities
  • GPC Testing for Sorbitan Esters (Non-Ionic Surfactant)
  • Molecular Weight Analysis of Polymeric Excipients
  • Polysorbates, Related Impurities, and Degradants

The data speaks for itself

The data speaks for itself

Linear dynamic range of ELSD and PS80 quantification of Infliximab drug products by ELSD and CAD. A) ELSD demonstrated a linear response within the range of 0.01 to 1 mg/mL. B) PS80 concentrations in four Infliximab drug products measured by ELSD and CAD.

Localization of oxidation on the Dlin-MC3-DMA molecule. Two structures are shown with possible locations for the oxidation, including (left) oxidation of the amine group of the polar head group and (right) epoxidation of one of the double bonds in the fatty acid chain. Below each structure are the low energy (parent ion) and high energy (fragment ion) spectra with matching fragment ions labeled based on in-silico prediction using each structure. Key fragment ions indicative of the location of the oxidation are labeled as A, B, and C. The fragment ion labeled D is the same peak as C but corresponds to an unlikely fragmentation in the epoxidated structure.

Hydrolyzed mAb oleic acid results. Oleic acid (OA) was detected in the infliximab sample at a concentration below 1% relative to the internal standard (IS) following base hydrolysis. Oleic acid was not detected in the trastuzumab sample. Results were confirmed using MS-based detection (inset).

RI overlay of all samples in 0.01 M NaH2PO4/0.2 M NaNO3 at pH 7 of all NaCMC samples.

Polysorbate 80 sample analysis by Arc HPLC System with an ACQUITY QDa Mass Detector, MS SIR data.

Chromatographic analysis of the polystyrene standards and PLGA samples using an Arc HPLC System with a strong solvent compatibility kit and RI detector.

GPC separation of the standard solution and sorbitan monooleate sample using an Arc HPLC System with a strong solvent compatibility kit and RI detector. Empower RT ratio: relative retention time (RRT).


Webinars and Resources



  • Journal Citations

Monitoring stability indicating impurities and aldehyde content in lipid nanoparticle raw material and formulated drugs

Monitoring stability indicating impurities and aldehyde content in lipid nanoparticle raw material and formulated drugs
  • Catálogos

BioAccord LC-MS System with ACQUITY Premier

BioAccord LC-MS System with ACQUITY Premier
  • Infográfico

Pharmaceutical QA/QC Infographic

Pharmaceutical QA/QC Infographic
  • User Manuals

Arc HPLC Strong Solvent Compatibility Guide

Arc HPLC Strong Solvent Compatibility Guide

Related

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Learn more about Raw Materials and Excipients Testing.

Learn more about Raw Materials and Excipients Testing.

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