Organic Impurity Test

Organic Impurity Test

Protheragen-ING Lab specializes in providing comprehensive pharmaceutical organic impurity testing services. With our expertise and state-of-the-art laboratory facilities, we help pharmaceutical companies ensure the safety and efficacy of their products by accurately detecting and analyzing a wide range of organic impurities.

Understanding organic impurities

Impurities can occur in active pharmaceutical ingredients (APIs) or pharmaceutical formulations throughout the manufacturing and storage. These impurities can take many forms, including known or unknown compounds, and volatile or non-volatile substances, and can originate from a variety of sources, such as starting materials, intermediates, by-products, and degradation products. They may also be caused by racemization or contamination between enantiomers. In either case, these impurities have the potential to adversely affect the biological activity of the drug.

Protheragen-ING Lab's specialized testing services

Our laboratory experts have the experience and expertise to provide you with comprehensive organic impurity testing services. We have extensive experience in identifying known and unidentified impurities, whether they are volatile or non-volatile, and whether they originate from raw materials, by-products, intermediates, degradation products, reagents, ligands, or catalysts.

  • For new APIs

We can help you understand the actual and potential impurities that are most likely to be present during synthesis, purification, and storage. Our experts will design and perform a series of rigorous laboratory tests to determine the types and levels of impurities that may be present, based on the characteristics of the drug and the manufacturing process. Through these tests, we can provide advice on how to control and minimize impurities to ensure that your API meets quality standards.

  • For new medicines

We can help you evaluate degradation products observed during manufacturing and/or stability studies, as well as impurities resulting from interactions with excipients and/or direct container closure systems. Our state-of-the-art laboratories are equipped to accurately analyze and characterize trace impurities in pharmaceuticals. We will meticulously analyze drug samples by international standards and regulations to ensure that your drug product meets requirements in terms of safety and quality.

Advantages of our organic impurities testing services

  • Professional team: We have an experienced team of professionals with extensive knowledge and technical expertise to accurately determine and characterize a wide range of organic impurities.
  • State-of-the-art equipment: Our laboratory is equipped with state-of-the-art instruments and equipment for highly sensitive analysis and detection of organic impurities.
  • Customized solutions: For each drug's characteristics and needs, we provide personalized testing solutions and recommendations to meet your specific requirements.
  • High-quality standards: Our testing processes are performed in strict accordance with international standards and regulations to ensure the accuracy and reliability of test results.
  • Timely delivery: We are committed to providing efficient services to ensure that test results are delivered in a timely manner to help you make quick decisions.

If you need organic impurities testing services, we will be happy to provide you with professional support and assistance. Please contact us and we look forward to working with you to ensure the quality and safety of your pharmaceutical products.