Analytical Sciences

With cGMP labs in the UK, Germany and US we provide contract analytical sciences research and testing services, consultancy and quality control solutions to support Chemistry, Manufacturing and Control (CMC) requirements at all stages of the drug development pipeline from discovery through preclinical and clinical development to commercial manufacture.

Our comprehensive service offering covers both chemical analyses, including assay, impurity and identification, as well as physicochemical properties. Our expertise covers characterisation, regulatory submission, stability and release testing across raw materials, excipients, drug substance and formulated drug product.

Solid Form Screening & Selection
Nitrosamine impurity testing and analysis

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

****For more information click here****

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