Impurity Reference Standards
Impurity Reference Standards are highly characterized compounds which are used to ensure the identity, strength, quality, and purity of medicines (drugs, biologics, and excipients), dietary supplements, and food ingredients. Any component of the drug product that is not the drug substance or an excipient in the formulation, is an impurity. Impurities are critical quality attributes of drug substances and drug products because they have the potential to affect safety and efficacy of the medicine. Regulatory bodies such as the U.S. FDA and ICH require impurity testing and controls to ensure drug safety and efficacy. Process related impurities can arise during the synthesis or manufacturing of the API or during drug formulation. Degradation impurities can also be formed during the manufacturing process and formulation stability studies. Identification of impurities is based on sound scientific appraisal of potential degradation pathways in the drug substance and drug product, including those impurities that arise from interactions of the drug with the environment, excipients, or the primary container–closure system. Observed impurities must be identified when their levels reach above the identification threshold. Impurities present at a level below the identification threshold generally do not require identification.
Axios offers highly characterized drug reference standards and drug impurities. Every product offered by Axios is extensively tested for purity and structure confirmation and comes accompanied with a detailed certificate of analysis. Axios guarantees reliable and accurate testing, and products can be used for qualitative as well as quantitative analysis.