In the complex world of drug development, ensuring the safety and quality of pharmaceutical products is of utmost importance. A crucial part of this process is identifying, quantifying, and controlling pharmaceutical impurities at every stage. The presence of unwanted compounds can greatly affect the safety and efficacy of the final pharmaceutical product. Regulatory bodies such as USP, EP, BP, JP, and ChP impose strict limits on impurity content in active pharmaceutical ingredients (APIs) and drug formulations, making impurity management essential for compliance and product quality.

Why Impurity Detection Matters

The quantity of impurities in pharmaceutical compounds determines not only the safety but also the viability of the drug product. The generic HPLC-UV method developed, should be validated for the impurity (ICH Q2R1), which would allow a subsequent determination of concentration in the drug product. The accurate concentration of the impurity in the drug product is very important to perform a toxicological assessment. To adhere to these ICH guidelines, it is important to identify, characterize and quantify the impurities that are above the prescribed threshold.

For drug developers, the challenge lies in detecting and controlling these impurities early in the process to avoid costly regulatory setbacks and delays in production. Traditional methods often overlook the detection of previously unidentified impurities, which can have serious consequences.

Axios Research – Expertise You Can Trust

At Axios Research, we combine a wealth of scientific expertise in organic synthesis and analytical chemistry, empowering us to identify and synthesize and/or isolate previously unknown impurities. With a strong foundation in NMR, HPLC/MS, and GC/MS methods, we provide highly accurate and reliable impurity reference materials that meet the strictest regulatory standards.

Our catalog includes a wide range of impurity reference standards, each backed by a comprehensive certificate of analysis. These documents provide un-ambiguous identity and purity data, validated using advanced methods specific to the impurity to ensure accurate representation.

With Axios Research as your partner, you can avoid surprises and ensure that your pharmaceutical products meet the rigorous safety and quality requirements.

Finding reliable suppliers of impurity reference materials is a common challenge in drug development. The lack of available impurity standards can severely hinder the development of robust analytical methods, which are crucial for regulatory approval. The delay in obtaining these materials can lead to costly setbacks and increase the risk of failure during product approval or release.

With Axios Research as a trusted source, you gain access to a wide range of impurity standards. Our experience in providing pharmaceutical impurity standards empowers your team to develop accurate, reliable, and compliant analytical methods. Whether you're working on identifying impurities for a new API or validating formulations, Axios Research ensures that you have the right materials to meet your needs efficiently and on time.

Let Axios Research help you streamline your drug development process by providing the reliable impurity standards you need to succeed.