β-lactam antibiotics are among the most crucial classes of antimicrobial drugs used in clinical settings. However, a significant concern surrounding these antibiotics is their potential to cause allergic reactions. The mechanisms behind these allergic responses have attracted widespread attention. Studies have found that polymer impurities are key contributors to triggering allergic reactions. These impurities refer to various impurities formed from the covalent bonding of antibiotic molecules with each other and manifest as dimers, trimers, and higher-order polymers. Polymer impurities presence can directly influence the therapeutic efficacy and safety profile of these drugs. As a result, the analysis and control of polymer impurities have become essential components of impurity profiling in β-lactam antibiotics. Our company has established a complete β-lactam antibiotic polymer impurity research platform, aiming to provide thorough, accurate analysis and control of impurities for β-lactam antibiotics, minimizing risks and maximizing efficacy.
Our Polymer Impurity Research Platform
Our platform, equipped with cutting-edge technology and spearheaded by a team of skilled researchers, offers a wide range of capabilities to address the challenges of polymer impurities. Concretely speaking, we utilize a meticulously structured research strategies and processes to study and analysis the polymer impurities. The strategies and processes entail several phases:
1Representative Sample Collection
We can perform systematic and moderate degradation tests, and combine samples at the end of their shelf life, samples at the end stage of accelerated stability tests and compatibility tests, to obtain samples rich in impurities.
2Polymer Impurity Identification
For the identification of polymer impurities, we develop and utilize a robust reversed-phase liquid chromatography-high resolution mass spectrometry (RP-LC-HRMS) method with features of gradient elution and strong eluting capabilities, and combine both primary and secondary mass spectrometry data to identify and categorize polymer impurities.
3Method Development
Following the impurities identification phase, we focus on method development. We design and optimize analytical methods specifically tailored to detect and quantify polymer impurities. This involves selecting the appropriate chromatographic conditions, detection systems, and sample preparation techniques to achieve high sensitivity and specificity for the impurities.
4Method Validation
Method validation is a critical step in our process, ensuring the reliability and accuracy of our analytical techniques. We will rigorously test for specificity, limits of detection (LOD) and quantitation (LOQ), linear dynamic range, accuracy, precision, solution stability, and method robustness.
5Establishment of Limits
To establish acceptable limits for polymer impurities, we take a comprehensive approach. We will assess multiple batches of reference samples and in-house developed products to determine polymer impurity levels. Incorporating pharmacopeial standards (where applicable) and ICH Q3 guidelines, we rationally formulate impurity limits.
By following these systematically developed research strategies and processes, our platform ensures the accurate identification, analysis, and control of polymer impurities, safeguarding the quality and safety of β-lactam antibiotics.
Platform Instruments and Equipment
Our platform boasts a plethora of advanced instruments and equipment:
- High-performance liquid chromatography (HPLC)
- Mass spectrometry (MS)
- Nuclear magnetic resonance (NMR) spectroscopy
- Gas chromatography (GC)
- Fourier transform infrared (FTIR) spectroscopy
- Liquid chromatography-mass spectrometry(LC-MS)
- …
Platform Advantages
- Comprehensive Approach: From identification to analysis, we offer a holistic solution to impurity control.
- Expertise: At our company, the polymer impurity research works are performed by a team of seasoned scientists and experts in the field of β-lactam antibiotics.
- Precision and Accuracy: Our platform utilizes the latest tools and technologies to ensure precise and accurate analysis of polymer impurities.
- Innovation Driven: We constantly innovate, integrating new scientific insights and technological advancements to stay ahead in impurity research.
Related Services
It should be noted that our service is only used for research, not for clinical use.
