News
Impurity Profiling: Characterization of unknown impurities in pharmaceuticals
Characterization of unknown impurities found in pharmaceutical substances and pharmaceutical products is a vital part of the regulatory approval process. According to ICH guidelines, if the estimation indicates an impurity content higher than 0.1%, it (...) Read more
U-Shape and Lean Lab: Improving productivity in the laboratory
The landscape of the life sciences ecosystem is ever-changing, and laboratory operations continually adapt to meet market demands, with efficiency and productivity crucial to the industry's evolution. Among the key drivers of this transformation are (...) Read more
FDA New Guidance: NDSRIs Recommended Acceptable Intake Limits
The US Food and Drug Administration (FDA) has taken a significant step to address the mutagenic and carcinogenic risk associated with Nitrosamine Drug Substance-Related Impurities (NDSRIs). This past August, the FDA introduced a final guidance (...) Read more
VICH GL18 (R2): Changes in Residual Solvents for Veterinary Products
As stated by the EMA (European Medicines Agency), residual solvents are organic volatile chemicals used or produced during the manufacture of active substances or excipients, as well as in the preparation of veterinary medicinal products. (...) Read more
