How to deal with Nitrosamine standards?

Dear, all

@Ariadna_Martinez gave me a question about how to deal with Nitrosamine standards. Please see the following.

Hi! My name is Ariadna and i am located at Mexico City in a quality control laboratory. We are new in this, since in Mexico the inclussion of nitrosamines control in our pharmacopoeia was recently added.

We just aquired a HPLC MS triple Cuadrupole for nitrosamines analysis and few days ago the usp standars arrived for starting the project.

I see that you have lot of experience (due to your publications). My question is… How do you manage the nitrosamines standards? do you use especial protectiv equipment (EPP)? Do you prepare the solutions in a biosafety cabinet?

Thank you.

And I’m very sorry I have no experience in dealing with nitrosamine standards for impurity analysis because we will ask our contract lab for the assay of nitrosamine impurity. From the point of occupational safety and health, what do they need? I would appreciate it if you could share your thoughts.

Here are all I can think of. And I think they can select essentials from them depending on the potential risk.

  • Storage with key
  • Usage records
  • Labeling of carcinogens
  • Risk assessment report
  • Designated area for handling harmful compounds
  • Designated balance and fume hood for handling harmful compounds
  • Disposable lab coat and gloves
  • Protective eyewear
  • SOP with handling instructions including disposal methods and cleaning methods when contaminated
  • SOP training for employee
1 Like

Thanks @Yosukemino

@Ariadna_Martinez te recomiendo comenzar con la revision de las hojas de seguridad de los estandares de referencia. Es claro que el manejo en el laboratorio requiere un cuidado especial dado las concentraciones de impurezas potencialmente genotoxicas con las que vas a trabajar.
Tambien tiene a tu dispocision el correo de apoyo tecnico USP o (en español)

@Ricardo.sanchez es el gerente de USP con base en Mexico y con mucho gusto podra apoyarte con cualquier inquietud o pregunta que pueda surgir


Thank you for sharing information, @Naiffer_Host. I think it’s helpful for @Ariadna_Martinez and her coworkers. Anyway, it’s important to set appropriate rules and follow them when dealing with highly potent compounds.