Product Highlight

Nitrosamine mitigation solutions from Roquette Health & Pharma

Product Highlight

Pharmaceuticals

United for safety – why Nitrosamine control matters

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DFE’s nitrosamine mitigation strategies
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Nitrosamine mitigation solutions from Roquette Health & Pharma
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United for safety - Navigating innovation with nitrosamine risks
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Webinar: United for safety - smarter excipients for nitrosamine risk mitigation
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Webinar: From lab to label - Analytical method advances in measuring nitrite in pharmaceutical excipients

Discover Roquette's low‑nitrite excipient technologies supporting regulatory compliance and safer oral solid dose formulations.

IMCD and its partner Roquette recognise nitrosamine risk management as a critical part of ensuring patient safety and regulatory compliance. IMCD can offer a range of excipient solutions and formulation support services designed to help drug manufacturers proactively reduce nitrosamine formation from the earliest stages of product development to market launch.

Roquette’s excipient-based mitigation approach

Approach	I: Reduce Nitrosating Agents	II: Control of Microenvironmental Conditions	III. Regulatory Alignment
Benefit	Roquette offers excipients manufactured with enhanced nitrite control. These products help minimise nitrite input without altering functional performance.	Moisture and pH can accelerate nitrosamine formation. Roquette solutions help by providing moisture and oxygen barriers or aid by alleviating low hygroscopicity when needed.	Roquette excipients support compliance with: ICH M7 (Assessment and control of DNA-reactive impurities). FDA Nitrosamine Guidance. EMA Nitrosamine Q and A. Ph. Eur. and USP-NF monographs.
Products groups	Low Nitrite METHOCEL™ HPMC Avicel® LN MCC	ETHOCEL™ Pearlitol® Mannitol Aquacoat® ECD

Featured products for Nitrosamine mitigation

Low Nitrite METHOCEL™ HPMC

Roquette’s low nitrite METHOCEL™ hydroxypropyl methylcellulose (HPMC) is an excipient line engineered to support nitrosamine mitigation. By significantly reducing nitrite content — a known precursor to nitrosamine formation — this product enables formulators to build safer oral solid dosage forms with minimal risk.

Key benefits:

Nitrite levels are consistently measured at or below 200 parts per billion and reported on every Certificate of Analysis.
Maintains established METHOCEL™ performance as a reliable binder, rheology modifier, film former, and controlled-release matrix.
Minimal need for reformulation when transitioning from standard grades.

This product was recognised with the 2025 NIE New Ingredient Award in the Excipients/Non-Actives category for its contribution to pharmaceutical safety and nitrosamine risk reduction, underscoring Roquette’s leadership in excipient innovation.

Avicel® LN MCC (Low Nitrite Microcrystalline Cellulose)

A low nitrite version of Roquette’s trusted microcrystalline cellulose binder and filler with a specified ≤100 ppb nitrite limit, offering formulators a way to reduce nitrosation risk in high-load tablet formulations.

Key benefits:

Nitrite levels are consistently measured at or below 100 parts per billion and reported on every Certificate of Analysis.
Functional binder and filler with documented low nitrite profile.
Ideal for immediate and modified-release tablets with known functionality.
Pearlitol® Mannitol / Co-processed fillers.
Non-hygroscopic mannitol (and co-processed mannitol combinations) with very low observed nitrite levels, suitable as a filler and bulking agent in moisture-sensitive and low nitrosamine risk formulations.

Non-hygroscopic mannitol (and co-processed mannitol combinations) with very low observed nitrite levels, suitable as a filler and bulking agent in moisture-sensitive and low nitrosamine risk formulations.

Benefits

Enhances stability for moisture-sensitive APIs.
Supports reduced nitrosamine precursor load in finished tablets.

Drug delivery & functional excipients (Support role in Mitigation)

While not all excipients below are marketed solely for nitrosamine control, they help enable formulations that reduce nitrosamine formation risk by supporting alternative strategies such as improved barrier control or reduced processing stress.

ETHOCEL™ Ethylcellulose & Aquacoat® ECD Coatings

Advanced polymeric coatings are used to make barrier membranes for controlled-release products. By providing robust moisture and process barriers, these coatings support stable API environments that are less susceptible to nitrosamine generation during manufacturing and storage.

POLYOX™ Polyethene Oxide Polymers

High-performance polymers for controlled release and drug delivery applications. These can help reduce excipient/API interactions that might otherwise contribute (directly or indirectly) to nitrosamine pathways.

KLEPTOSE® Cyclodextrins & D-glucose-based Excipients

Although primarily used for solubility and taste masking (e.g., KLEPTOSE® HPBCD), many glucose and maltodextrin-derived excipients in Roquette’s portfolio have very low intrinsic nitrite content, helping minimise formation routes for nitrosamines.

Benefits

Enhance API solubility and formulation flexibility.
Can contribute to safer (low nitrite) excipient systems.

Roquette portfolio alignment with Nitrosamine risk mitigation strategies

Product	Primary Function	Nitrosamine Mitigation Mechanism	Risk Category Addressed
Low Nitrite METHOCEL™ HPMC	Binder/matrix former	Reduced nitrite input	Nitrosating agents
Avicel® LN MCC	Filler/binder	Reduced nitrite input	Nitrosating agents
Pearlitol® Mannitol	Filler/diluent	Low moisture uptake, low nitrite	Moisture-driven formation
KLEPTOSE® Cyclodextrins	Solubilizer	Low intrinsic nitrite	Excipient contribution
ETHOCEL™ / Aquacoat® ECD	Barrier polymer	Moisture and oxygen control	Secondary formation pathways
POLYOX™ Polymers	Controlled release	Reduced API–excipient interaction	Process-related risk

Partner with IMCD for safer formulations

Nitrosamine mitigation isn’t just a compliance hurdle - it’s a commitment to patient wellbeing. Roquette’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.

Excipients by API Nitrosamine risk profile

API Risk Scenario	Recommended Excipient Strategy	Suitable Roquette Products
Secondary/tertiary amines present	Reduce nitrosating agents	Low Nitrite METHOCEL™ Avicel® LN
Moisture-sensitive API	Control water activity	Pearlitol® Mannitol ETHOCEL™
High API load	Maintain compression with low impurity risk	Avicel® LN MCC
Modified release	Barrier + low nitrite matrix	Low Nitrite METHOCEL™ + ETHOCEL™
Reformulation after nitrosamine detection	Minimal functional change	Low nitrite drop-in replacements

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