Product Highlight

BASF’s Holistic Approach to Nitrosamine Mitigation

Product Highlight

Pharmaceuticals

United for safety – why Nitrosamine control matters

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BASF’s Holistic Approach to Nitrosamine Mitigation
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Science‑driven excipient design, advanced digital tools, and transparent data

Why nitrosamine mitigation matters

Nitrosamines are a class of potentially mutagenic impurities that can form when nitrosating agents (e.g., nitrites) react with secondary or tertiary amines, often present in APIs or impurities. Since the first detection in valsartan in 2018, regulatory agencies have required a lifecycle‑based risk assessment and mitigation strategy for nitrosamines across pharmaceuticals.

As a leading excipient manufacturer, BASF Pharma Solutions supports customers by addressing nitrosamine risk at the source, focusing on:

Minimisation and control of nitrosating agents in excipients
Robust analytical methods and transparent data sharing
Digital tools for formulation‑specific risk assessment

BASF mitigation strategy: A holistic framework

Preventive excipient design

BASF’s approach starts with chemistry‑driven excipient design. Its povidone-based excipients (PVPs, copovidones, crospovidones) have been produced for more than 80 years using manufacturing processes that pose no intrinsic nitrite risk.

Key principles include:

Tight raw‑material control
Process conditions that avoid nitrite formation
High lot‑to‑lot consistency across global production sites (Germany, USA, China)

Analytical excellence and transparency

BASF has continuously invested in high-sensitivity nitrite test methods, including ion chromatography with defined LOQ/LOD values tailored to the excipient matrix.

Customers receive:

Risk assessment statements aligned with IPEC questionnaires
Historical nitrite trend data
Access to validated testing methodologies

Key BASF products supporting nitrosamine control

Kollidon® (standard) grades	Kollidon® NT (Nitrite Tested) grades
Kollidon® grades (PVP, VA, CL) are widely used binders, film formers, and disintegrants with no nitrites detected to date within the limits of validated analytical methods. Benefits: Very low or non‑detectable nitrite content High global supply reliability No need for reformulation or requalification	Introduced in 2025, Kollidon® NT grades expand BASF’s mitigation offering by adding batch‑specific nitrite testing with results reported on the Certificate of Analysis (CoA). Available grades include: Kollidon® 30 NT Kollidon® VA 64 NT Kollidon® CL NT Key benefits Enhanced documentation for regulatory filings Identical manufacturing process to standard grades No additional qualification required

Kollidon® (standard) grades

Kollidon® NT (Nitrite Tested) grades

Kollidon® grades (PVP, VA, CL) are widely used binders, film formers, and disintegrants with no nitrites detected to date within the limits of validated analytical methods.
Benefits:

Very low or non‑detectable nitrite content
High global supply reliability
No need for reformulation or requalification

Introduced in 2025, Kollidon® NT grades expand BASF’s mitigation offering by adding batch‑specific nitrite testing with results reported on the Certificate of Analysis (CoA).
Available grades include:

Kollidon® 30 NT
Kollidon® VA 64 NT
Kollidon® CL NT

Key benefits

Enhanced documentation for regulatory filings
Identical manufacturing process to standard grades
No additional qualification required

Digital tools for nitrosamine risk mitigation

ZoomLab® – nitrosamine risk assessment module	RegXcellence® – quality and regulatory documentation
ZoomLab®, BASF’s Virtual Pharma Assistant, includes dedicated apps for nitrosamine assessment and mitigation. Capabilities include: Identification of APIs susceptible to nitrosation Prediction of potential nitrosamine structures Application of the Carcinogenic Potency Categorization Approach (CPCA) Formulation‑specific contribution analysis (API dose, excipients, process type)	Through RegXcellence®, customers can retrieve: CoAs and quality statements Audit information Regulatory support documents Available 24/7 in a unified platform, supporting faster and more confident submissions.

BASF’s value in nitrosamine risk control

BASF’s nitrosamine mitigation approach combines:

Preventive excipient design
Documented low‑nitrite performance
Advanced analytical methods
Digital, formulation‑specific risk tools
Transparent data sharing and regulatory support

This integrated strategy enables pharmaceutical manufacturers to meet regulatory expectations without costly reformulation, while maintaining high product quality and patient safety.

Partner with IMCD for safer formulations

Nitrosamine mitigation isn’t just a compliance hurdle, - it’s a commitment to patient well-being. BASF’s robust portfolio of low-nitrite excipients, backed by rigorous analytical screening and regulatory insight, positions us as a trusted partner for pharmaceutical manufacturers striving to deliver high-quality, safe medicines worldwide.

Discover how our solutions can elevate your formulation strategy — request some of our nitrosamine mitigation products today.