It’s been over a year since the ICH Q3D guidelines were updated to include cutaneous and transcutaneous limits.
This crucial change allows the evaluation of topical products with risk-appropriate permitted daily exposures, rather than adopting more stringent parenteral limits.
Topical products, ranging from complex multicomponent patches and wound dressings to creams containing inorganic salts and polymers, require a tailored approach to sample preparation and analysis to ensure all the elements of concern are quantitatively determined.
To ensure comprehensive digestion and achieve the low limits of detection needed for these often high-dose materials, we’ve leveraged our extensive experience in elemental impurities analysis by developing bespoke digestion regimes, utilising HF if required.
For insights into ICH Q3D and its implementation, read the EMA guidelines.
