Pharmaceuticals
Services
Extractables and leachables testing
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
- Specialised tests including Nitrosamines, PAH’s
and MBT
- Trace metals
- Synthesis of reference standards
- End-product compliance testing.
For further information, contact us:
Email: pharmaInfo@lgc.co.uk
LGC, The Heath Business Park, Runcorn,
Cheshire WA7 4QX, UK
Tel: +44 (0)1928 515163
Fax: +44 (0)1928 500125
To receive more
information about our services please register your details
here