Products and services
Analytical 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 considerable 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>.
Our Sectors
More about our work in the Pharmaceuticals sector
Contact details
For more information, contact
Madhu Mittra
+44 (0)20 8943 7580
pharmaceutical@lgcgroup.com
General:
+44 (0) 208 943 7000
info@lgc.co.uk