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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).