Chemical compounds are scarcely one hundred percent pure in nature. When undergoing separation or chemical reactions for analysis in the laboratory, compounds may also become contaminated by other groupings of molecules or adulterations. For this reason, purification is a critical and necessary step to ensure superior purity standards, especially for the new drug discovery and development process.
Purification is essential in the pharmaceutical industry to minimize any undesired materials that could cause harm to a human being—or compromise the efficacy of a drug. As compound impurities can exist in radiolabeled active pharmaceutical ingredients, facilities should follow the appropriate practices to achieve chemical purity. Let’s closely examine the importance of purification for radiolabeling compounds.
Why Purification Processes Matter
In an analytical chemical context, purification is a process of physically isolating, separating, or removing substances considered to be foreign or contaminating. The ability to effectively separate chemical mixture quantities into purer forms reaps advantages for people worldwide.
Due to the broad efforts of chemists to characterize complex systems by their purest forms, greater opportunities are available to deepen understanding in scientific research. Not to mention innovatively engineering and safely developing new advancements within the pharmaceutical field.
Radiochemical Purity Standards
The importance of purification for radiolabeled compounds lies mainly in quality, safety, and efficacy. Chemical purity is a term that refers to the quantity of the desired chemical in a radiopharmaceutical. Properly identifying the chemical purity of an isotopically labeled compound determines if any undesired solvents or substances are present that shouldn’t be used in a study. If so, these impurities could influence the characteristics of the final product.
Testing for purification with the latest tools and qualified instrumentation provides key insight into whether or not a compound is suitable for use in a development project. Some of the most reliable analytical equipment used in the industry for purification techniques are liquid chromatography (HPLC) and nuclear magnetic resonance (NMR) analysis.
Completing Radiosynthesis Correctly
A high-purity radiolabeled test substance is the foundation of modern clinical studies. Along with the correct choice of radioisotopes and label positions for tracking metabolites, assuring purity is fundamental for keeping time and money expenses at a minimum.
Moravek has the skilled ability to completecustom radiolabeled synthesisand purification services.With facilities equipped with state-of-the-art analytical instrumentation, we prepare active pharmaceutical ingredients to support clinical research. Our team expertly handles radiolabeled compounds to ensure the production of quality materials. Learn more about Moravek’s synthesis methods and services to meet project specifications on our website.