Trace Impurity Analysis Platform

Trace impurities are a particular concern in the pharmaceutical industry because even small amounts of impurities can have significant consequences on the overall quality of the drug product. Trace impurities can impact the stability, shelf-life, and bioavailability of the drug, leading to potential health risks for patients. Regulatory authorities, such as the Food and Drug Administration (FDA) in the United States, have strict guidelines and limits on trace impurities in pharmaceuticals to ensure the safety and efficacy of drug products. Therefore, it is crucial for pharmaceutical companies to closely monitor and control trace impurities throughout the entire drug development and manufacturing process through rigorous testing. To address this need, our company has developed and established a advanced trace impurity analysis platform, which provides comprehensive and accurate analysis of trace impurities in pharmaceutical products.

Meet Our Trace Impurity Analysis Platform

At our trace impurity analysis platform, we offer cation and anion residue analysis, elemental impurity analysis, and residual solvents analysis. Our team of experienced scientists and analysts utilizes advanced analytical techniques and instrumentation to detect and quantify these impurities with high precision and accuracy. For more details, please check out the links below.

Residual Cation and Anion Analysis Platform

Our company has established a comprehensive cation and anion trace impurities analysis platform which has the ability to provide method development and validation, as well as testing services for a wide variety of trace anionic, cationic, organic acids and organic bases impurities.

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Elemental Impurity Analysis Platform

Our company has established a specialized elemental impurity analysis platform which has the ability to provide method development and validation, as well as testing services for a wide variety of metal elements with high toxicity, moderate toxicity or low toxicity.

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Residual Solvents Analysis Platform

Our company has established a specialized residual solvents analysis platform which has the ability to provide method development and validation, as well as testing services for all types of residual solvents listed in the ICH Q3C (R8) guidelines.

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Platform Advantages

• Cutting-edge Technology: We invest heavily in state-of-the-art equipment and technology to ensure that we can detect even the most minute impurities in drugs. With cutting-edge analytical instruments such as HPLC, GC, HS-GC, and ICP-MS, we can accurately identify impurities at trace levels, providing our clients with precise and reliable results.
• Experienced Team of Experts: Our team of highly skilled scientists and analysts possess extensive experience in trace impurity analysis. They are well-versed in the latest analytical techniques and methodologies, allowing them to tackle complex impurity profiling challenges with precision and efficiency.
• Comprehensive Services: At trace impurity analysis platform, we offer a wide range of services related to trace impurity analysis. From method development and validation to impurity quantification, we provide comprehensive solutions to meet our clients' diverse analytical needs.
• Quality and Compliance: We adhere to strict quality control measures and follow regulatory guidelines to ensure the accuracy and reliability of our analyses. Our laboratory facilities are equipped with state-of-the-art infrastructure that meets industry standards, and our processes are validated and documented to guarantee the integrity of our results.
• Customer Satisfaction: We understand the importance of timely communication, transparency, and collaboration in building strong client relationships. Our dedicated customer support team is always available to address any inquiries or concerns, and we strive to deliver results that exceed our clients' expectations.

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