Sharing insights on determining trace levels of nitrite in lactose at 2025 Impurities Summit

Wasserburg, Germany: – Pharmaceutical excipient industry leader MEGGLE will contribute expertise and insights on the urgent issue of nitrosamine contamination in pharma products to the upcoming 9th Impurities: Genotoxic, Nitrosamine, & Beyond Summit.

MEGGLE is also a sponsor of the event, which is once again being hosted in Vienna.

Measurement challenges

MEGGLE Head of Research, Ricarda C. Leister, will address the meeting on the subject of “Challenges in Determining Trace Levels of Nitrite” in excipients.

Her presentation will draw on her extensive research on a new method to analyze trace levels of nitrite in lactose having a sufficient sensitivity which is also subjected in a MEGGLE White Paper (see Resources).

She will also reference the recent studies carried out with instrumentation specialist Thermo Fischer Scientific, the Technical University of Munich and in-house. Several possible ion chromatography (IC) set-ups were tested for trace level determination of nitrite in a range of lactose excipients.

A better method

The address will highlight the importance of low nitrite levels in lactose, since it is used as a filler or carrier excipient in so many pharmaceutical formulations.

Mrs. Leister will show how IC can be used as a superior method for determining trace levels of nitrite in lactose excipients. However, several critical factors, such as co elution and sample preparation techniques, need to be considered to reliably reach a high sensitivity.

For derivatization-based methods Nitrite LOQ is not limited by instrument sensitivity but by ubiquitous nitrite background contamination.

In general, her presentation will highlight potential pitfalls and opportunities for method optimization in measuring lactose excipients for nitrite impurities.

Lowe nitrite levels

Since acidic reaction with nitrite impurities levels are a primary risk factor in contamination of powders by the probable nitrosamine carcinogens N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), a primary strategy is to keep nitrite levels as low as possible.

Accordingly, MEGGLE is now introducing ultra-low nitrite versions of its lactose excipients, beginning with GranuLac® 200 Low Nitrite, Tablettose® 100 Low Nitrite, and FlowLac® 100 Low Nitrite, with further grades in development.

About MEGGLE

Bavarian-based company MEGGLE is one of the world’s experts in co-processing and powder technology. From its roots as a dairy operation in the late 1880’s, MEGGLE has become one of the world’s leading manufacturers of pharmaceutical grade lactose, supplying the pharmaceutical industry with a broad-based and unique lactose product portfolio.

MEGGLE’s Business Unit Excipients has harnessed outstanding product quality and intelligent innovation to become a global leader in the manufacture of lactose-based excipients, focusing on products for direct tableting and dry powder inhalation.

A multidisciplinary team of committed and highly qualified people allows MEGGLE clients to benefit from pioneering experience and innovation in industrial milk and whey processing. The company constantly strives to develop high-technological, functional products for solid dosage forms and DPI applications, where they can deliver maximum performance.

The company has introduced several revolutionary products, notably Tablettose®, the world’s first agglomerated pharmaceutical lactose grade for direct tableting, Cellactose® 80, a pioneering co-processed excipient based on powdered cellulose and lactose for outstanding compression and flow properties and RetaLac®, the first direct compressible co-processed excipient using Hypromellose and lactose for sustained release formulations.

To learn more, visit: https://www.meggle-pharma.com/en/home.html

About Impurities Summit 2025

Founded in 2016, the annual Impurities: Genotoxic, Nitrosamine, & Beyond Summit addresses the increasingly pressing issues of detection and control of nitrosamines and other genotoxic impurities (GTIs) in pharmaceutical products.

The meeting shares knowledge on current regulatory frameworks, toxicological and technical challenges of impurity identification, and effective risk mitigation strategies to ensure product safety and regulatory compliance.

The 9th Impurities Summit will again be a two-day meeting, commencing April 9, hosted in Vienna, this time at the Novotel Wien Hauptbahnhof.

Topics to be explored at this meeting will include essential strategies for ensuring compliance with ICH M7 and Q3D guidelines, effective management of DNA-reactive N-nitrosamine impurities to reduce carcinogenic risks, innovative methods and technologies for identifying, monitoring, and controlling genotoxic impurities, and navigating CMC regulations concerning genotoxic impurities.

The event is organized by Vonlanthen Events, with further information at: https://www.vonlanthenevents.com/en/9th-impurities-genotoxic-nitrosamine-beyond-summit

Resources

Click on Risk Mitigation of Nitrosamines formation in Drug Products: Role of Excipients to access MEGGLE White Paper.