Analytical and Materials Science Solutions

A team of problem solvers ready to partner with you.

Supporting pharmaceutical and consumer healthcare with development, validation, and application of testing methods.

Over 20 years expertise in analytical and materials science solutions to help solve your most complex challenges.

Let us help you to discover, develop, and manufacture medicines and products to improve the quality of life.

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Our scientists partner with you to provide a consultative, flexible and dependable solution for the development, validation,
and application of testing methods.

  • Analytical Chemistry
  • Impurity ID
  • Extractables and Leachables
  • Elemental Impurities
  • Foreign Matter Analysis
  • Materials Characterisation
  • Solid Form Screening and Selection

We support the regulatory Chemistry, Manufacturing and Control (CMC) compliance of your drug substance and drug product through the complex challenges faced in drug development, solving issues at all stages of manufacture.

  • Method Development
  • Method Validation
  • Characterisation
  • Quality Control
  • Stability Testing
  • Troubleshooting

Specific Centres of Excellence, are focused on being at the forefront of scientific and industry developments, requirements and solutions.

DDS Solid Form Screening and Selection Centre of Excellence

Solid Form Screening and Selection Centre of Excellence

Our Solid Form Screening and Selection Centre of Excellence builds on our expertise in Materials Science analysis to offer discovery of high quality crystalline forms of small molecule development candidates.

The centre is supported by expert and experienced materials science analysis using a wide range of analytical techniques operating to the highest quality standards.

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DDS Impurity and Contamination Centre of Excellence

Impurity and Contamination Centre of Excellence

Our Impurity and Contamination Centre of Excellence are experts in the identification and quantification of trace impurities in a wide range of materials used throughout the global pharmaceutical and healthcare sectors.

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Analytical and Materials Science Solutions

Nitrosamines, such as N-nitrosodimethylamine (NDMA) are reported to be a probable human carcinogens. A recent FDA statement revealed that NDMA impurities were found in ranitidine medicines, leading to the recall of the blood pressure and heart medications losartan, valsartan and irbesartan.

The FDA is reported to have requested that drug companies conduct laboratory testing to examine levels of NDMA and related impurities in ranitidine, as well as other drug products.

Recent guidance issued by the FDA confirms a triple quadrupole LC-MS/MS method may be used as an alternative or confirmatory method for the LC-HRMS method.

LGC have developed and validated LC-MS/MS methodology, with improved specificity, suitable for the determination of a full range of drug product and process related Nitrosamines, including NDMA and NDELA:

  • N-Nitrosodibutylamine      
  • N-Nitrosodiphenylamine      
  • N-Nitrosodi-n-propylamine       
  • N-Nitrosomethylethylamine      
  • N-Nitrosomorpholine      
  • 1-Nitrosopiperidine      
  • 1-Nitrosopyrrolidine

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