Applications
API impurities are used for analytical testing and quality control to ensure the safety and efficacy of pharmaceutical products.
 
Description
An impurity in a ‘drug substance/API’ may be defined as an unwanted chemical substance which differs from the chemical composition of the drug substance. It may differ in chemistry, structure, enantiomer etc.
 
Preparation
API impurities are prepared through controlled chemical reactions, degradation studies, or isolation processes to mimic or obtain degradation products, intermediates, or related substances that aid in analytical testing and quality assessment of pharmaceuticals.
 
Chemical Properties
API impurities encompass a range of chemical entities, including related substances, degradation products, and intermediates, providing critical insights into the chemical composition and purity of the active pharmaceutical ingredient.
 
Definition
An impurity in a ‘drug substance/API’ may be defined as an unwanted chemical substance which differs from the chemical composition of the drug substance. It may differ in chemistry, structure, enantiomer etc.
Chemical formula C11H12N2O2
Molar mass 204.229 g·mol−1
Melting point 280-285°C
Boiling point 447.9°C at 760 mmHg
Other name 2-Amino-3-(1H-indol-3-yl)propanoic acid
HS Code 29224990
Technical AnalysisSpecification Typical Values
CAS NO. 73-22-3
IUPAC (2S)-2-amino-3-(1H-indol-3-yl)propanoic acid
Solubility Soluble: 0.23 g/L at 0 °C,
Impurities in active pharmaceutical ingredients (APIs) are unwanted chemicals that can affect the safety and efficacy of pharmaceutical products.