Validation and
testing of

 Validation and testing of N-Nitrosamine

At GVK BIO, we have expertise to develop sensitive analytical methods for Nitrosamine impurity quantification using GCMS or LCMSMS for both finished products and APIs. The specifications of the analytical method will be in accordance to requirements all regulatory bodies across globe including USFDA.

We have proven track record in developing a single analytical method using LCMSMS for the below six Nitrosamine impurities:

1. N-Nitrosodimethylamine (NDMA)
2. N-Nitrosodiethylamine (NDEA)
3. N-Nitrosoethylisopropylamine (NEIPA)
4. N-Nitrosodiisopropylamine (NDIPA)
5. N-Nitrosodibutylamine (NDBA)
6. N-Nitrosomethyl-4-amino-butyric acid (NMBA)

We design protocols to drive method development, method validation and finished product samples which is suitable for regulatory filing requirements across the globe.

Solutions we offer

  • Quick turnaround time with comprehensive report
  • Dedicated project management team
  • Analytical validations in accordance with applicable GMP/PQRI/USP regulations 
  • Study of product contact material and safety risk assessment which includes metal testing
  • Extractable and leachable toxicological evaluation (in-silico) by VEGA software including risk assessment and validation
  • Quantitative and qualitative analysis of extractables and leachables
  • Analytical testing and validation of N-Nitrosamines


Formulation & Analytical Solutions

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Developability Assessment of Small Molecules

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