Extractable and leachables testing

By: LGC Limited  22/07/2009
Keywords: Method Validation

 LGC offers a full extractables and leachables service to clients in accordance with current guidelines issued by the PQRI , and covering the specific tests outlined within the US Pharmacopeia, FDA and EMEA Guidelines.
These services include:
Controlled extraction studies of primary and secondary packaging systems
Toxicological assessment of extractables profile to determine leachables monitoring protocols 
Method development for QC testing of incoming materials and components
Method development for leachables testing in final drug products
Analysis of leachables in stability study samples
Identification of unknowns  

Keywords: Method Validation