An impurity caused by a chemical change in the drug ingredient during manufacturing and/or storage of the drug product due to, for example, light, temperature, pH, water, or reactivity with an excipient and/or the immediate container-closure system.
A chromophore is a group of atoms and electrons in organic compounds which communicate with light to produce color. Chromophores exist within the molecule as a short conjugated system or a chain of atoms linked by alternating single and double bonds.
A buffer is a solution that can maintain its pH after the addition of acidic or basic components. It can neutralize modest amounts of additional acid or base, keeping the pH of the solution reasonably constant. This is critical for procedures and/or reactions that require precise and consistent pH levels. Buffer solutions have a functional pH range and capacity that determine how much acid/base can be neutralized before the pH changes, as well as how much it changes.
The European Medicines Agency (EMA) is an agency of the European Union (EU) that evaluates and regulates pharmaceutical goods. Prior to 2004, it was called the European Agency for the Evaluation of Medicinal Products (EMEA).The primary goal of the European Pharmaceuticals Agency (EMA) is to preserve and promote human and animal health by analyzing and monitoring pharmaceuticals across the European Union (EU) and the European Economic Area.
An abbreviated new drug application (ANDA) contains information submitted to the FDA for examination and possible approval of a generic drug product. Once approved, an application may produce and promote the generic drug product as a safe, effective, and less expensive alternative to the brand-name drug it references. It must prove that a proposed generic medicine is equivalent to an existing approved reference-listed drug (RLD) in terms of safety, efficacy, and quality.