In pharmaceutical manufacturing the mutagenic impurities are among the most critical safety concerns. These impurities are responsible for the damage of DNAs, even at trace levels.
For multinational pharmaceutical companies, CDMOs, biotech innovators, and API manufacturers operating across multiple jurisdictions, regulatory alignment is now a strategic priority
Green chemistry is no longer optional in pharmaceutical research. It is essential because the regulatory agencies expect safer processes for chemical development. Also, the companies demand cost efficiency and cleaner reactions.
If you work in pharmaceuticals, chemistry, biotech, or regulatory affairs, you will hear two terms again and again: drug substance and drug product.
They sound similar, but they mean very different things.
Impurity analysis in pharmaceuticals is a critical quality control measure. Impurities, arising during synthesis, storage, or handling, can significantly affect a drug's safety, efficacy, and stability...
The Nitrosamine (NA) issue, often termed the "Saga," has been a focal point of attention for both the pharmaceutical sector and regulatory entities over the past half-decade...
Impurity standard materials are critical tools in pharmaceutical analysis, enabling the accurate identification, quantification, and control of impurities in drug substances and drug products...
High-Performance Liquid Chromatography (HPLC) is a widely used analytical technique for impurity identification and quantification in the pharmaceutical industry...
