Impurity Identification, Made Clear.
Setting the Standard
At Gateway, we are setting the standard in impurity identification, working with regulatory authorities like the FDA and EMA to navigate stringent guidelines for the control of pharmaceutical impurities. These guidelines mandate drug manufacturers to both identify and quantify impurities, and implement measures to reduce them to permissible levels.
Impurity Identification
Analytical methods such as high-performance liquid chromatography (HPLC) and gas chromatography (GC) are used to identify impurities. These methods allow for separating, identifying, and quantifying impurities in a drug product. Once identified, steps can be taken to remove or reduce the impurities to acceptable levels.
Pure Solutions at Gateway Analytical
Impurities in pharmaceuticals refer to any unwanted substance in a drug product. These impurities can arise from various sources, including the raw materials used to manufacture the drug, the manufacturing process, or packaging materials. Regulatory bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established guidelines for pharmaceutical impurity control. These guidelines require that drug manufacturers identify and quantify impurities in their products and take steps to minimize their levels. The policies also establish limits for acceptable levels of impurities, which must be met before a drug can be approved for use.
In the world of extractables and leachables (E&L) studies within the pharmaceutical and medical device sectors, the identification of impurities stands as a critical requirement. Rely on Gateway Analytical for expert guidance in impurity identification, ensuring your products not only meet but exceed the highest safety standards.
Identify with Precision, Deliver with Confidence
Identifying impurities is essential to ensure the drug product or medical device is safe and effective. Impurity identification testing includes multiple parameters such as chromatography, mass spectrometry, and spectroscopy. The results obtained from impurity identification testing are used to make informed decisions about the quality of the product and to ensure that the product meets the required safety standards.
