Automated Total Nitrosamine Analyser (ATNA)

Frequently Asked Questions

• Which industries use the ATNA?

  The ATNA is used primarily in pharmaceutical and cosmetics manufacturing, where regulatory requirements for nitrosamine testing have increased significantly since 2018. In cosmetics, it is used to demonstrate compliance with the 50 μg/kg total nitrosamine limit under EU Cosmetics Regulation EC 1223/2009. In pharmaceuticals, it is used as a screening tool to identify when nitrosamine formation is occurring ahead of targeted speciated analysis under ICH M7. It is also used in food contact materials, rubber, and other industries where total nitrosamine content is a relevant safety parameter.

   

• What does the ATNA measure?

  The ATNA measures the total amount of nitrosamines in a sample and reports a single combined value expressed in ppb. This includes known nitrosamines as well as those that form unexpectedly during production or storage, and compounds for which no individual standards exist. The system achieves sensitivity below 1 ppb, which is sufficient for screening against regulatory limits such as the 50 μg/kg threshold under EU Cosmetics Regulation EC 1223/2009.

• How does the ATNA relate to the ATNC method?

  The ATNA automates the ATNC (Apparent Total Nitrosamine Content) method. ATNC is the recognised analytical approach for total nitrosamine screening, used across cosmetics, pharmaceuticals, and related industries to assess overall nitrosamine formation risk. The method works by chemically cleaving nitrosamines to release nitric oxide, which is then detected by the TEA. The ATNA handles this entire process automatically, including sample heating, NO release, and detection, removing the need for manual steps and allowing high-volume batch runs.

• What is the difference between the ATNA and GC-TEA?

  The ATNA and GC-TEA both use the 800 Series Thermal Energy Analyser as their detector, but they answer different analytical questions. The ATNA measures total nitrosamine content and reports a single combined value for all nitrosamines in the sample. It does not identify individual compounds. GC-TEA couples the TEA with a gas chromatograph, separating compounds before detection so that individual nitrosamines such as NDMA, NDEA, and NDELA can be identified and quantified separately. The two systems are complementary. The ATNA is typically used for screening; GC-TEA is used for targeted speciated analysis when the screening result indicates formation is present.

• Does the ATNA identify individual nitrosamines?

  No. The ATNA is designed for total screening rather than compound identification. It reports a single value for all nitrosamines present in the sample, including unknown or unexpected compounds. When a total nitrosamine result indicates formation is occurring, targeted GC-TEA or LC-MS methods can then be used to identify and quantify individual compounds. This two-stage approach is the recommended workflow in both cosmetics and pharmaceutical testing environments.

• How does the ATNA fit alongside GC or LC methods?

  The ATNA is used as the first step in a two-stage screening workflow. It provides a fast total nitrosamine value that indicates whether formation is occurring. When a sample exceeds the screening threshold, targeted GC-TEA or LC-MS analysis is used to identify and quantify the individual nitrosamines responsible. This approach focuses detailed analytical time on the samples that need it, reducing the overall burden on more resource-intensive speciated methods.

• What type of samples can be analysed?

  The ATNA is used with a wide range of sample types including solid dose pharmaceutical products, tablets, creams, lotions, shampoos, and other complex matrices. Samples are prepared in sealed headspace vials and loaded into the 120-vial autosampler. Sample preparation and handling depend on the matrix. Ellutia can advise on suitability before purchase.

• Does the ATNA require nitrosamine standards?

  Only one. The ATNA requires a single nitrosamine standard for calibration purposes, typically NDMA, though other nitrosamines can be used. Beyond that, no individual compound standards are needed. Once calibrated, the system detects all nitrosamines present in the sample, including unknown or unexpected compounds for which no reference standards exist. This is one of the key advantages of the ATNC approach. The response is not limited to compounds you have standards for.

• Is the ATNA suitable for routine testing?

  Yes. The ATNA handles routine, high-volume screening with fully automated operation. It holds 120 headspace vials and runs unattended sequences, including overnight batches. With throughput of up to 10 samples per hour, a laboratory running overnight sequences can process a full tray of samples without operator input. For cosmetics manufacturers running compliance screening against the EU 50 μg/kg limit, or pharmaceutical teams managing routine formation risk assessment, the ATNA is designed to fit into existing laboratory workflows without specialist GC knowledge.

• How quickly are results available?

  The ATNA processes up to 10 samples per hour. Once samples are loaded and the sequence is started, the system runs automatically without operator input. For laboratories running overnight batches, a full tray of 120 vials can be processed in a single unattended run, with results available the following morning. Actual throughput depends on method settings and sample matrix, but 10 samples per hour is the standard operating rate.