We're committed to delivering the critical nitrosamine impurity data you need to achieve regulatory approval and stay on market
Starting August 2023, approved, marketed, and under review drugs must follow the FDA's risk-based safety assessment guidance for nitrosamine drug substance-related impurities (NDSRIs).
We're here to help you assess and control nitrosamine impurities in your drug products. When you partner with Element, you'll get the personalized attention and support you deserve from leading scientific experts at the forefront of evolving regulations.
Together, we'll ensure your products are safe and effective - and meet FDA and industry expectations.
Explore a partnership with Element for testing to FDA guidance
Let us know how we can support you in meeting FDA requirements for nitrosamine drug substance-related impurities - click the orange "Get more information" button and fill out a short form. A member of our team will be in touch with you. Keep scrolling to learn more about the FDA's new guidance for nitrosamine impurities, and scroll further down for more information about how Element can help you meet FDA expectations.
Helping you navigate FDA guidance for nitrosamine drug substance-related impurities (NDSRIs)
3 key things to know about the guidance:
- Applies to manufacturers and anyone submitting drug applications, including OTC products; excludes NDSRIs found in products for patients with advanced cancers
- Manufacturers and applicants who haven't previously considered NDSRIs must evaluate risk within 3 months of the new guidance (FDA recommends by November 1, 2023)
- Element can help you develop and validate methods for the analysis of NDSRIs
By August 1, 2025, the FDA recommends manufacturers and applicants submit data if they fall under 3 specific scenarios:
- Evaluated NDSRI risk previously - perform confirmatory NDSRI testing and submit required drug application changes
- Have drug products with NDSRIs - ensure NDSRIs meet FDA's recommended acceptable intake (AI) limit
- Looking to deviate from the AI limit set by the FDA - scientifically justified rationale must be provided and application changes submitted
Let us know how we can support you in meeting FDA requirements
If you're interested in connecting with our team to discuss how Element can help you meet FDA expectations, click the orange "Start the conversation" button and fill out a short form. Looking for more information? Keep scrolling to learn more about how we can help you navigate the evolving regulatory landscape and comply with FDA guidance.
We'll help you control and evaluate the risk of nitrosamine impurities
Robust QC testing of chemically synthesized APIs, raw materials, and process reagents is critical to evaluating and assessing the risk of nitrosamine impurities - and controlling and preventing nitrosamine contamination. With a demonstrated history of success testing for nitrosamine impurities, we’ll help you satisfy regulators with robust method development, validation, and testing to detect nitrosamines at low parts per billion (ppb) levels of detection in both drug products and drug substances.
You’ll experience seamless integration with your team - Element's experienced scientists with a wealth of knowledge will provide dedicated support. Together, we'll assess the risk of nitrosamine contamination to pharmaceuticals and OTC medications, delivering accurate, high-quality data on your timeline.
Whether your drug product is approved, marketed, or under review, we'll deliver the data you need to achieve regulatory approval, support application changes, and stay on market. Let us know how we can help you comply with FDA regulations for nitrosamine impurities - just fill out a short form and a member of our team will be in touch with you.
Get to know Element
Scroll down to explore a handful of our many services to help you achieve regulatory approval and ensure compliance.
Your global partner from discovery to market
Still researching? Here are a handful of our many services to help achieve regulatory approval quickly and efficiently.
Pharmaceutical and Biopharmaceutical Unknown Identification and Impurity Testing
Our experts work closely with customers at every stage of the product lifecycle to identify unwanted compounds and ensure products are pure, safe, and quality.
Compendial Testing
ICH, USP, EP, BP and JP monograph tests of raw material, drug substance/product, starting material, cell banks, vectors, bulk harvest and control cells.
Excipient Raw Materials and Container Testing
Find out how we make certain that quality and safety of your excipient raw materials and containers are maintained.
Extractables and Leachables Studies
Our extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
Analytical Chemistry Testing
We offer our clients full product and analytical chemistry solutions. Our GLP and cGMP chemistry offerings include chemical characterization of active ingredients, testing of product-specific impurities, physical chemistry analysis and storage stability testing.
Chemistry, Manufacturing, and Controls (CMC) Consulting Services
We provide consulting services for Chemistry, Manufacturing, and Controls (CMC) product development in the pharmaceutical and biotechnological industries.
Environmental Monitoring
Our Environmental Monitoring programs allow pharmaceutical manufacturers and compounders to measure and monitor cleanliness and contamination levels within their facilities.
CMC Product Development Services
Find out how our CMC development services support clinical trials and accelerate the overall drug development process for our customers