Application Notes: General

Often, method development activities are performed “on the fly” with tight timelines to achieve the goal of developing robust methods quickly. Unfortunately, the approach to method development is an often-overlooked aspect of the process. In this app note, we talk about employing a systematic screening protocol, which utilizes a structured decision-making process, alleviates the pressure on the analyst to select the best set of conditions, and streamlines the method development process.

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Quantitative ethylene oxide analysis in Polysorbate 80 excipient is greatly simplified using SIFT-MS, with a time to first test result that is eight-fold faster than the current compendial method and a daily sample throughput that is 9- to 14-fold higher. In this application note, a simplified EtO method is presented that uses a much smaller quantity of PS80 for analysis than headspace GC-FID.

This application note describes head-to-head comparison of GC-FID and SIFT-MS analyses of Class 2A and 2B residual solvents. The techniques perform similarly for linearity and repeatability, but SIFT-MS provides superior performance for accuracy and recovery. Furthermore, SIFT-MS provides greater than 11-fold increase in sample throughput and significantly reduces the time taken to report quantitative results (over six times faster for a full calibration set).

This application note describes how SIFT-MS greatly simplifies formaldehyde detection and quantitation through direct, instantaneous, and sensitive (sub-ppbV) sample ionization. Sample throughputs of up to 250+ samples/day are possible using the method detailed in this study.

Learn how PFAS, microplastics, and chromium detection in environmental samples can be greatly enhanced with the latest LC-MS, laser directed IR spectroscopy, and IC-ICP-MS technologies

Application Note 048

Application Note 030

Application Note 047

Quantitative analysis of volatile nitrosamine impurities in drug products is greatly simplified using SIFT-MS and has a three-fold throughput advantage (excluding sample prep benefits) over chromatographic methods. This application note describes the headspace-SIFT-MS analysis of ranitidine products which achieves a limit of quantitation of 2 ng g-1 for NDMA in 500 mg of drug product.

The ability of SIFT-MS to monitor critical volatile organic compounds (VOCs) produced by a bioreactor in real-time at low parts-per-billion by volume (ppbV) concentrations is demonstrated. This application note presents the results of a pilot-scale feasibility study conducted over several weeks, demonstrating the utility of SIFT-MS for maximizing production outcomes.

Crucial phosphorylated compounds can be analyzed via polymeric iHILIC-(P) Classic HILIC columns and MS. This is applicable for targeted and non-targeted metabolomics.

This application note describes a scenario in which Syft Tracer replaces five chromatography systems and still has significant available sample capacity. Next gen SIFT-MS provides rapid, chromatography-free workflows which revolutionize volatile compound analysis.

The increased demand for AAV therapies can be met by using LC-MALS to efficiently assess AAV purity without the financial burden.

This application note demonstrates the speed of headspace-SIFT-MS methods for the analysis of benzene in personal care products (PCPs). In less than three hours, seven-point calibration curves can be generated and accurate quantification of benzene in PCPs achieved. SIFT-MS provides rapid, sensitive, and robust analysis of benzene and other contaminants in a variety of commercial products. Integration with a headspace autosampler enables rapid screening of hundreds of samples per day.

In this application note, the charge variant characterisation of IgG4-based mAbs was performed using a BioPro IEX QF anion exchange column coupled to an MS detector.

Cannabinoid separation can be difficult with the presence of coeluting isomers. This application shows how a combination of LabSolutions MD (Method Development) software and powerful i-PDeA technology can help determine the optimal method for cannabinoid separation and deconvolute remaining co-eluting peaks after optimization.

This application showcases how a compact, affordable single quad LCMS can be easily integrated into existing laboratories for measurement of PFAS in diverse samples where adherence to regulated methods (e.g., EPA 533, 537.1, and 1633) is not required, or samples where expected concentrations are larger than sub ppb levels.

This application news presents instrument operating conditions and instrument method performance statistics, including method linearity, accuracy, and precision, for priority pollutant pesticides and PCB congeners. The method validated in this application acted as guidance in developing ASTM D8543 Test Method for Determination of OCPs and PCBs in Aqueous Solution by a GC/MS/MS which is intended for proposal to EPA as an alternative test procedure (ATP) for EPA 608.3

PFAS concerns demand sensitive testing. EPA Method 1621 screens for adsorbable organic fluorine (AOF). The Profiler-F Analyzer boasts sensitivity, recovery & precision.

This application note describes the evaluated quantification performance of eight nitrosamine impurities using an Agilent 6495D triple quadrupole LC/MS (6495D LC/TQ) system coupled with an Agilent 1290 Infinity II bio LC system and Agilent APCI source.

Recently, attention has been drawn to the use of microdroplet reactions for antibody analysis. The NIST IgG1 mAb was used to optimize microdroplet reaction conditions on two reactions, IdeS cleavage and disulfide bond reduction, using the Agilent Jet Stream ESI source.

In this app note you will learn how to develop a highly specific, sensitive, and reproducible method for the quantitation of N-nitroso dabigatran etexilate impurity in dabigatran etexilate mesylate drug substance using an Agilent 6495C triple quadrupole LC/MS (LC/TQ) coupled to an Agilent 1290 Infinity II LC.

This application note presents an alternative method using time-of-flight liquid chromatography/mass spectrometry (TOF LC/MS) and hydrophilic interaction chromatography (HILIC) that enables accurate and repeatable analysis of diverse oligonucleotides without using ion-pairing reagents.

Earlier assessment of molecules provides valuable insights into the manufacturing developability of molecules, reducing the need for unnecessary experimentation. The Intabio ZT system has the potential to make in-depth characterization of biopharmaceutical product charge variants quicker and more efficient to meet demanding timelines during early-phase clinical development.