CMC analytical 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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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. 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.