Pure substances are made up of a singular type of atom or a singular grouping of molecules. Within the context of chemistry, the means by which a substance is measured for this standard is known as purity. Pure substances have well-defined physical properties that establish their classification of purity. The importance of purity in chemistry lies in effective research and the safety of consumer usage. Purity standards relate directly to quality control in pharmaceutical production.
Qualitative Detection: Grades of Purity
From a systematic standpoint, purity is detectable in chemical substances with skilled scientific examination. Qualitative detection of purity grades is a useful scientific tool for quality evaluation. The use of purity analysis within pharmaceuticals is imperative to pinpoint the presence or identity of any impurities within a sample. Impurities are any components not defined as active substances or excipients of a particular product.
Impurities arise from the sources of starting materials and their contaminants. While the guarantee of one hundred percent purity within a pharmaceutical product is not obtainable, complex synthesis through analytical methods can determine the presence of unwanted organic or inorganic chemicals and residual solvents. Ninety-nine percent purity is the minimum standard. An appropriately graded chemical or molecule is necessary for the complete manufacturing of quality compounds.
The Chemical Nature of Products: Synthetic Analysis
The importance of purity in chemistry is to bring assured quality to life. Products of a chemical nature containspecific substance characteristics. The vital scrutiny and analytical testing of purity composition will address the safety and efficacy of new drug substances. A higher purity level within manufactured compounds is necessary to meet regulatory quality control standards and complete a development project.
For custom radiolabeled synthesis, reach out to Moravek. Our expert team of chemists and biologists have an amplitude of synthetic experience in a wide array of pharmaceutical settings. Moravek’s GMP-compliant facility can verify the quality of your product through techniques that assess purity standards. To prepare the highest quality radioactive products, we use qualified analytical equipment to employ liquid chromatography and NMR analysis methods. Contact us with any questions regarding our purification and testing processes.