35 Reagents, Reference Materials & Laboratory Chemicals


New reagents for Karl Fischer titration


On many occasions it is essential to know the amount of water present in a sample. Water can influence the reactivity, stability, and shelf life, etc, of products. Karl Fischer titration, established in the early 20th century, remains the widely accepted method globally. This technique relies on the Bunsen reaction, featuring a rapid two-phase process correlating the consumed I2 with the sample’s water content.


The first KF reagents developed contained pyridine in their formulation, supposedly essential for the reaction, but later experiments showed that pyridine only acts as a buffer substance and could be replaced by other basic compounds capable of carrying out the same function. For this reason, the new Karl Fischer Aquagent® reagents contain imidazoles instead of pyridine, alternative bases with good buffering capacity that allow stable titration end points to be quickly obtained.


The newly developed manufacturing and control method allows us to launch a new Aquagent® with multiple advantages for the user.


Scharlau’s new Aquagent® formulations achieve a more stable and robust Karl Fischer factor, faster stabilisation, a greater reaction speed and a more stable endpoint. Leading manufacturers of Karl Fischer titration equipment, including Metrohm, Mettler-Toledo and Hanna, recommend Scharlau’s Aquagent® reagents. More information online: ilmt.co/PL/LoXD


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New multicomponent standard streamlines nitrosamines testing


Restek introduces the Nitrosamines 7 Standard, a novel multicomponent solution designed to streamline pharmaceutical impurities testing. This innovative product consolidates seven key nitrosamines into a single ampul, alleviating the complexity and challenges associated with sourcing individual compounds. By offering a comprehensive selection of frequently targeted nitrosamine compounds, Restek aims to enhance the efficiency and accuracy of laboratory testing procedures.


The Nitrosamines 7 Standard serves as a certified reference standard (CRM), providing laboratories with a reliable internal standard for nitrosamine analysis. With its formulation optimised for stability, each analyte is present at a concentration of 100 µg/mL, facilitating the construction of calibration curves and ensuring consistent and accurate results. This standardised formulation not only simplifies sourcing but also minimises the need for time-consuming standard preparation procedures.


Furthermore, the Nitrosamines 7 Standard is available in two independently manufactured lots, each accompanied by verified lot-to-lot agreement. This ensures consistency and reliability across different batches, enabling laboratories to maintain high standards of quality control and data integrity. Additionally, an internal standard is included at a concentration of 1000 µg/mL, further enhancing the accuracy and reproducibility of analytical measurements.


More information online: ilmt.co/PL/kAw8 62422pr@reply-direct.com


Achieving superior instrument precision with fl uorescent calibration standards


Starna Scientific Ltd, with 50 years experience in developing and manufacturing fluorescence reference materials, proudly highlights its enhanced polymer fluorescent references. These advanced materials, featuring proprietary dyes, offer improved calibration accuracy and longevity for fluorimetry systems.


Calibration is crucial for precision in fluorescence-based analytical methods, especially in sectors like life sciences where regulatory compliance is essential. Starna’s innovative references ensure more accurate measurements and instrument control.


These materials are versatile, applicable across fluorometers, point-of-care devices, PCR & diagnostic devices, and microscopy systems. Their robustness ensures traceability and ease of comparison between instruments and measurements, vital for long-term performance.


Starna’s ISO 17034 accreditation guarantees stability and homogeneity, critical for reference material production. In addition, all fluorescent references undergo rigorous individual quality control processes to ensure they meet specific custom requirements. This meticulous attention to detail ensures that these fluorescent references consistently deliver accurate and reliable results for customers. The US Pharmacopeia General Chapter <853> endorses these references for fluorescence instrument qualification.


These references enable precise spectral corrections, essential for inter-instrument comparisons and consistent performance. Available in various formats and concentrations, they ensure optimal performance across different systems.


Starna’s dedication to accuracy and innovation drives the development of these advanced materials, pushing calibration boundaries while maintaining high quality standards. More information online: ilmt.co/PL/QmwD


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GMP-compliant cell culture medium optimises API manufacture


AMSBIO has unveiled an upgraded GMP-compliant version of its animal-origin-free, chemically defined StemFit™ iPSC expansion medium. StemFit™ Basic04 CT is engineered to enhance the growth and pluripotency of induced pluripotent stem cells (iPSC) while meeting the stringent Good Manufacturing Practice (GMP) standards for Active Pharmaceutical Ingredients (API).


With its superior iPSC performance, StemFit™ Basic04 CT facilitates expansion and sustains long-term genetic stability, optimising single-cell passaging for large-scale stem cell production. This medium is meticulously manufactured and quality-controlled in strict accordance with GMP guidelines within a certified ISO 13485 facility.


Each bottle of StemFit™ Basic04 CT is accompanied by a certificate of analysis and all necessary documentation, ensuring a seamless transition to clinical applications. Aisha Amari, Business Development specialist at AMSBIO, emphasised the significance of iPSCs in revolutionising cellular medicines and highlighted the pivotal role of GMP-compliant StemFit™ Basic04 CT in iPSC manufacturing for cell therapy.


Amari stated: “Using StemFit™, we hope researchers can further advance translational research, drug discovery and development and help bring high-quality iPSC based- therapies from bench to bedside.”


More information online: ilmt.co/PL/XOq8 62569pr@reply-direct.com


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