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Analysis of Contamination in Pharmaceutical Products

LGC

Contamination can occur at any stage of product manufacture and can arise from the raw materials, cleaning materials, chemicals or equipment used in production, packaging or from degradation during storage. It can be inorganic or organic in nature andin solid or liquid form.

In many cases, the contamination can be due to visible or sub-visible particulate matter, and we are able to identify and count such particles.

For further information on particulate contamination, please see our data sheet:

Foreign Particulate Matter Analysis in Pharmaceutical Products

We have many years experience in solving contamination problems in the pharmaceutical and healthcare sector. Typical examples include:

  • Degradation of API or excipients
  • Matter coming out of solution
  • Change of polymorphic form or presence of other polymorphic forms
  • Residual solvents
  • Discoloration of tablets
  • Discoloration or films on production equipment

LGC has in-depth technical expertise and a wide range of technologies including:

  • Optical microscopy with image analysis
  • Scanning electron microscope fitted with EDX for qualitative elemental analysis
  • High Resolution SEM with Field Emission Gun
  • FTIR and FTIR microscopy
  • NMR
  • X-ray diffraction
  • GC/MS
  • HPLC
  • Thermal analysis
  • Inorganic analysis techniques such as ICP/OES, ICP-MS and AA
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