Impurities can arise during the synthesis, manufacturing, or storage of drugs, and their presence can impact the stability, bioavailability, and overall safety, efficacy and quality of the drug product and thus can lead to adverse effects on patients. Therefore, it is vital to conduct thorough impurity research to understand the nature of impurities present. Impurity preparation, impurity synthesis and impurity structure identification play a crucial role in this regard, which streamline the process of impurity research. At our company, we have established an impurity preparation and structure identification platform, offering comprehensive service to pharmaceutical companies and research institutions.
Our Impurity Preparation and Structure Identification Platform
Our impurity preparation and structure identification platform offers one stop services to pharmaceutical companies and research institutions. These services include:
Impurity Directed Synthesis
Providing services for the directed synthesis of impurities found in raw materials, intermediates, drug substances, and formulations. It helps in understanding the impurity profile and optimizing synthetic routes.
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Impurity Structure Identification
Providing structural identification and analysis services for process-related impurities, degradation impurities, and other impurities present in pharmaceutical products. This helps in determining the root cause of impurity formation.
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Degradation Impurity Studies
Offering services for the degradation pathways of impurities, separation and preparation of degraded impurities in drug substances and formulations. This is crucial for ensuring product stability and shelf life.
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Impurity Preparation and Separation
Offering services for the preparation and isolation of impurities in raw materials, intermediates, drug substances, and formulations. This aids in the accurate identification and quantification of impurities.
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Impurity Qualitative Analysis
Conducting qualitative studies on impurities present in raw materials, intermediates, drug substances, and formulations. This allows for the identification of unknown impurities and potential risks associated with them.
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Instruments and Equipment
The impurity preparation and structure identification platform is equipped with state-of-the-art instruments and equipment for impurity analysis. These include:
- High-performance Liquid Chromatography (HPLC) systems for separation and quantification of impurities.
- Gas Chromatography-Mass Spectrometry (GC-MS) systems for identification of volatile impurities.
- Nuclear Magnetic Resonance (NMR) spectrometers for structural elucidation of impurities.
- Infrared (IR) and Ultraviolet-visible (UV-Vis) spectrophotometers for spectroscopic analysis of impurities.
- Liquid Chromatography-Mass Spectrometry (LC-MS) systems for comprehensive analysis of impurities in complex pharmaceutical matrices.
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Process at Our Platform
The service process at the impurity preparation and structure identification platform involves the following steps:
- Consultation and Project Planning: Clients discuss their requirements and objectives with our platform experts, who then develop a customized project plan.
- Signing the Contract: Once the proposal is finalized, a formal contract is drafted by our company, detailing all the agreed-upon terms and conditions. And then, it is signed by our client and our company.
- Laboratory Experiment: Depending on the customer's needs, this may include a range of different experiments such as impurity synthesis, impurity separation and purification, impurity structure identification and qualitative analysis, etc.
- Reporting and Documentation: A comprehensive report detailing the impurity profile, structures, and content is provided to the client for regulatory submissions and internal records.
Impurity preparation and structure identification is essential for ensuring the quality, safety, and efficacy of pharmaceutical products. By effectively identifying and characterizing impurities, pharmaceutical companies can enhance their product development processes, meet regulatory expectations, and ultimately safeguard public health. Contact us today to learn more about how our platform and services can benefit your projects.
Related Services
It should be noted that our service is only used for research, not for clinical use.
