Pharmaceuticals
Services
Foreign particulate matter analysis in pharmaceutical
products
There is an increasing requirement in
pharmaceutical development to characterise, as well as count,
visible and sub-visible particles in pharmaceutical products. LGC
has significant expertise and is able to carry out both routine
measurements and method development in this area.
We have a proven track record in this field,
having investigated numerous problems covering active
pharmaceutical ingredients, excipients, final dosage forms, process
and packaging materials.
Our facilities include:
- ISO14644 Class 5 standard (FS 209 Class 100) laminar flow
cabinets to minimize contamination of samples
- Extensive methods for the isolation of particulate matter eg
manipulation of small particles, filtration and centrifugation
- Optical microscopy (compound and stereo
microscopes) with image analysis
- Scanning electron microscope fitted with EDX
for qualitative elemental analysis of particles
- High Resolution SEM with Field Emission
Gun
- FT-IR microscopy
- Raman microscopy .
Using one or more of the above techniques, we
are able to count numbers of particles present in samples, measure
their size, record photographic images and also determine the
chemical nature of the particulate matter.
In addition, we are able to carry out the
following specific tests:
- Particulate Matter in Injections USP <788> (Ph.Eur.
2.9.19, Particulate Contamination: Sub-Visible Particles, ICH
Guidelines Q4B)
- Particulate Matter in Ophthalmic Solutions USP <789>
.
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
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