Extractable & Leachable
ACSD brand new laboratory for E&L and Analysis in trace, located c/o ACSD4 Vimercate (MB) Plant, avails of the most advanced equipment and expert technical staff to perform Extractables and Leachables analysis as well as Analysis in trace such as Mutagenic Impurities, Nitrosamines and Elemental Impurities.
The Laboratory is an important and strategic resource to support ACSD Group for Elemental Impurities for the compliance with the ICHQ3D guideline, as well as for identification and quantitation of Nitrosamine and Mutagenic Impurities.
Compounds to look for:
- Very volatile Organic Compounds.
HS-GC/MS: headspace injector, combined Gas Chromatography coupled with Mass detector
- Volatile and semi-volatile Organic Compounds.
GC/MS: Gas Chromatography coupled with Mass detector.
- Non-Volatile Organic Compounds.
LC/MS: Liquid Chromatography coupled with UV and Mass detector
- Metals
ICP/MS: Inductive Coupled Plasma with Mass detector
Our Laboratories are FDA, AIFA and ANVISA accredited.
Studies will be conducted in compliance with ISO 17025 and the requirements of GMP and GLP with respect to System validation (laboratory equipment and computerized systems).
E&L laboratory to respond to the challenges of existing (ICH Q3D/ICHM7) and future (ICHQ3E) regulations with good capability
