Sources of Impurities in Pharmaceutical Substances


The impurities in pharmaceutical products can be attributed not only to the drug substance or inert ingredients used for formulating a drug product but they can also be brought into the drug product through the formulation process or by contact with the packaging of the various impurities that can be found in drug products. The … Read more

Types of Impurities in Pharmaceuticals


The impurities in pharmaceuticals are organic or inorganic material, or residual solvents other than the drug substances or ingredients that arise out of synthesis or unwanted chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon aging of both API and formulation. Pharmaceutical Impurities can be of three types: 1. … Read more

Effects of Impurities in Pharmaceuticals

Effects of Impurities in Pharmaceuticals

Impurities may bring about incompatibility with other substances. Impurities may lower the shelf life of the substances. Impurities may cause difficulties during formulations and the use of the substances. Sometimes Impurities change the physical and chemical properties of the substances. Impurities present in a solid organic compound tend to have 2 effects on the melting point. First, they tend to lower the overall melting point of the compound versus … Read more