Pharmacopoeial Impurity Standards
“Any component of the drug product that is not the chemical entity defined as the drug substance or an excipient in the drug product.” (ICH Q6A: Specifications). It is important to give greater consideration to these detrimental impurities.
Impurities in drug substance (i.e., active pharmaceutical ingredient) or drug product can arise due to synthetic/manufacturing processes, degradation, storage conditions, container, excipients, or contamination. They can be identified or unidentified, volatile or nonvolatile, organic or inorganic species.
Synthesis of Pharmacopoeial & Non-Pharmacopoeial Impurities is a major part of Subtle Pharma.