Genotoxicity is a property of some substances that can cause damage to genetic information contained in an organism and ultimately cause cancer, induce mutation or deformity. For example, carcinogens in tobacco, as well as carcinogenic events such as food packaging plasticizers that have been raging in the past, are the culprits of being genetically toxic.
But do you know? As a weapon against disease, drugs may also produce genotoxic impurities (GTI) during synthesis, preparation, and storage. If we can't detect these impurities in time, then the good medicine is a poison.
As a result, regulators around the world (including the European Medicines Agency EMEA, the US FDA, and the International Coordinating Meeting ICH M7) have published numerous standards and specifications for genotoxic impurities to ensure drug safety. In the consistency evaluation of generic drugs carried out in China in recent years, more detailed industry norms have been proposed regarding the impurities of drugs.
In the traditional detection of genotoxic impurities, we usually use LC-MS or GC-MS methods for detection. Although these two methods are effective and the detection accuracy is high, they require very complicated operations or need A pre-column derivatization step to increase the detectability of the analyte. This means that the traditional method cannot be applied to daily tests with large detection and short detection time.
In this regard, Waters has introduced a method of UPLC combined with mass spectrometer QDa. This approach eliminates the need for pre-column derivatization and provides the selectivity and sensitivity needed to rapidly analyze low concentrations of potential genotoxic impurities in pharmaceuticals. At the same time, if the method is combined with UV, it can achieve fast and accurate confirmation and quantification of genotoxic impurities, thus meeting the daily testing needs.
In "genotoxic lipid acid detection" for example, methyl benzenesulfonate, ethyl ester and isopropyl ester chemical structure shown in the following table. The UV and MS chromatographic data obtained by isolating these compounds are shown in Figure 1. The UV spectrum below indicates that the benzenesulfonic acid elutes before its methyl ester, ethyl ester and isopropyl ester. The ACQUITY QDa MS data collected over the mass range (100 to 250 Da) is called the total ion chromatogram (TIC), indicating that the alkyl ester can be detected in the ESI+ mode and the benzenesulfonate can be detected in the ESI-mode. acid. Mass spectral data indicated that the ester formed the ammonium adduct [M+NH4] + .
In addition to the above cases, multiple cases demonstrate that ACQUITY QDa is able to quickly and accurately confirm peaks by mass. The use of mass spectrometry and single ion scanning (SIR) increases the specificity and sensitivity of low concentrations of impurities in the analytical sample. The good reproducibility and accuracy of the MS method at the limit of quantitation indicates that the mass spectrometer is suitable for routine monitoring of genotoxic impurities in pharmaceuticals. In addition, the results of the UPLC combined with the mass spectrometer showed that the corresponding limit of quantitation for the 1 to 5 mg/mL API met the regulatory requirements for genotoxic impurity analysis.
Overall, the ACQUITY QDa Detector is a stable and easy-to-use detector that complements UV detection as a quadrature detection technology. It provides accurate and reliable results and is the ideal technology for routine drug testing in QC laboratories.
For detailed application details, please visit the Waters official website search "720005875" to download the "ACQUITY QDa Mass Detector QC Application Collection".
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In one sunny morning, a sweet corn or glutinous corn is a good choice for breakfast to kick-start the day. Corn has a richer taste than other staple food. Glutinous corn has a sweet and waxy taste. It's also a filling food to fill up for the day, supplement the nutrition that the human body needs.
Fruit corn. The outer leaves are pale green, and the inner grains are white or yellow.The sweetness is higher than sweet corn, but the starch content is low, rich in vitamin E and cellulose, can fight aging and help digestion.Ideal for raw food, mixed with vegetables into salad;It can also be steamed, but don't cook it for too long, about five minutes.
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