Article: Nitrosamine Impurities Deadline: Are Your Products Compliant?

The FDA recently released its guidance on nitrosamine contamination and set deadlines for risk assessment updates and full compliance. This is an issue that affects no small portion of the industry: about 30% of approved active pharmaceutical ingredients (APIs) are susceptible to nitrosamine formation. In this article, we discuss the guidance in detail, look at various approaches for reducing the presence of impurities, and demonstrate how Adare's unique nitrosamine mitigation process can help products achieve compliance.

Download the Document

    * denotes a required field

    Please fill out the information below. If you are already registered, and this information will be filled out for you.


  • Please enter your first and last name.

  • Please enter the name of the company or institution you work at.

  • Please enter your mailing address.

  • Please enter the phone number you would like to be contacted at.

  • Please enter the e-mail address you would like to be contacted at.


    • By submitting this form, you consent to Pharmaceutical Outsourcing storing your email address and contact information and transmitting your contact information to the content sponsor. You may request to be removed at any time.