Analytical Sciences

With cGMP labs in the UK, Germany and US and a track record of success in regulatory audits, including the FDA, we have particular specialty in materials science and pharmaceutical analysis.

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. Our team has extensive experience in synthetic and medicinal chemistry and will work with you to tailor the screening protocols to maximise hit rate while minimising compound requirement.

Our Impurity and Contamination Centre of Excellence comprises two UK laboratories, which are regularly inspected by the UK MHRA for cGMP compliance.

• Detection of a full range of potential nitrosamine impurities
• Organic impurity characterisation and structural elucidation
• Inorganic trace analysis
• Extractable and leachable testing
• Contamination and foreign particulate analysis

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.

Extractable and leachable testing
Material science testing
Elemental assay and impurity testing
Structural elucidation
Foreign particulate matter testing
Process and product related impurity testing
Nitrosamine impurity testing and analysis
Organic assay and impurities testing
Solid Form Screening & Selection
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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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