Drug Product Testing

 
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Drug Product Testing

Providing full support for finished product testing on tablets, capsules, injectables, oral medications and medical devices

We are regarded as the high quality and low risk analytical service provider of choice for the release testing of clinical and commercial drug product supplies. Our proven expertise supports an extensive range of dosage forms and our services cover all typical drug product release tests. A license to hold controlled drugs means we can look after your whole range of products.

Utilizing our extensive library of in-house methods, statistical exploration tools, USP apparatus I & II, and emerging analytical technologies, such as UPLC and Empower 3, we can reduce your method development, validation time and associated costs while generating accurate and reliable data.

Drug product services include:

  • Assay and impurities by HPLC/UPLC
  • Dissolution testing
  • Elemental impurities (USP<232> and <233>)
  • Moisture content
  • Physical testing (XRPD, NMR, Mass Spectroscopy, TGA, DSC, DVS, PSD, Microscopy)
  • Stability studies

Impurities such as N-Nitrosodimethylamine (NDMA) have been highlighted by the US FDA, EMA and other regulatory authorities as an area for concern as they are probable human carcinogens. We have responded to regulatory guidance and offer laboratory drug testing to detect levels of NDMA and related impurities within our mass spectrometry laboratory. Our expert team have successfully performed testing on a number of APIs and Finished Products as per FDA method FY20-006-DPA-S_LCMSMS 10/17/2019 to establish levels of NDMA. Read our paper to find out more.

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