TITLE:
A Detailed Review on Analytical Methods to Manage the Impurities in Drug Substances
AUTHORS:
Dharmpal Singh, Rekha Isharani
KEYWORDS:
Impurities, Drug Substances, Pharmaceutical Drug Products
JOURNAL NAME:
Open Access Library Journal,
Vol.10 No.8,
August
29,
2023
ABSTRACT: Impurities, particularly those associated with the API (active pharmaceutical ingredient) and causing deterioration or interaction, may lower a drug’s quality, safety, and efficacy. The successful reduction and control of impurities in pharmaceuticals rely on safety-based impurity limits. Many methods have been developed to define a practically safe dosage of impurities, with an emphasis on daily exposure limitations. They include permissible daily exposure (PDE), acceptable intake (AI), the threshold of toxicological control (TTC), and staged TTC. So, the less than lifetime (LTL) limits for mutagenic impurities were implemented, which are based on Haber’s law, which stipulates that concentration and exposure durations are both crucial for estimating potential safety risks to people. Before moving on to further processes like analytical techniques and acceptance criteria, sources of impurities must be properly characterized so that regulatory requirements and management plans may be defined and adhered to. Pharmaceutical impurities and the current worldwide regulatory requirements for their control were discussed. The main aim of the study is to examine analytical methods to manage the impurities in drug substances. The study also focuses on the quality by Design approach for the analysis of impurities in pharmaceutical drug products and drug substances. In addition to this, the study also analyses strategies for the identification, control, and determination of genotoxic impurities in drug substances. Genotoxic impurities can be quantified at the trace level by using analytical techniques like LC-MS/MS, and GC-HS-MS/MS. Lastly, the study examines the importance of impurity analysis in pharmaceutical products”.