Impurity Analysis and Research Platform
Impurity Analysis and Research Platform

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Impurity Analysis and Research Platform

In the pharmaceutical industry, ensuring the safety and efficacy of drug products is of paramount importance. One critical aspect of this process is the analysis and research of impurities present in drug substances. These impurities can arise from various sources, including the manufacturing process, raw materials, and degradation of the drug substance over time. While some impurities may be harmless, others can pose serious risks to patient safety, including toxicity, carcinogenicity, and decreased efficacy of the drug product. Therefore, it is crucial to identify, quantify and analyze these impurities to ensure the quality and safety of drug products. To address this need, our company has developed a state-of-the-art impurity analysis and research platform, which provides impurity preparation and structure identification, trace impurity analysis and genotoxic impurities analysis services.

Please click the links below for details:

Impurity Preparation and Structure Identification Platform

Our impurity preparation and structure identification platform offers impurity directed synthesis, impurity preparation and separation, impurity structure identification, impurity qualitative analysis and degradation impurity studies.

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Trace Impurity Analysis Platform

Our state-of-the-art trace impurity analysis platform provides cation and anion residue analysis, elemental impurity analysis, and residual solvents analysis.

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Genotoxic Impurities Analysis Platform

Our genotoxic impurities analysis platform offers comprehensive, state-of-the-art services and support to help pharmaceutical companies navigate the complexities of GI analysis, method development and verification, genotoxicity prediction and many others.

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Polymer Impurity Research Platform

Our polymer impurity research platform provides thorough, accurate analysis and control of impurities specifically tailored for β-lactam antibiotics, minimizing risks and maximizing efficacy.

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Residual Protein Analysis Platform

Our residual protein analysis platform offers method development and validation as well as analytical testing servicesto address the challenges of residual protein detection and quantification in the pharmaceutical industry.

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Platform Advantages

  • Experienced Team of Professionals: Our team of scientists and researchers have extensive experience in impurity analysis and are dedicated to delivering high-quality results for our clients.
  • Rapid Turnaround Time: Our platform is equipped with state-of-the-art instruments and software that enable fast and efficient impurity analysis, allowing us to provide quick turnaround times for our clients.
  • Regulatory Compliance: We follow strict quality control measures and adhere to regulatory guidelines to ensure that our impurity analysis meets industry standards and requirements.
  • Cost-effective Solutions: We offer competitive pricing options for our impurity analysis services, making them accessible to a wide range of clients, from academic researchers to pharmaceutical companies.

It should be noted that our service is only used for research, not for clinical use.

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