Unexpected Peaks? How We Troubleshoot Chromatography Problems

Chromatography is a cornerstone of analytical testing for nicotine products. It allows us to quantify active ingredients, track impurities, and ensure batch consistency. But what happens when your chromatogram shows an unexpected peak, or when known peaks start to drift?

It is more common than you think. And resolving it quickly is critical to avoiding delays in product development or regulatory submission.

What Causes Unexpected Peaks?

Unexpected or "ghost" peaks can appear for a number of reasons:

• Degradation of ingredients, especially under stress conditions (e.g., heat, light)
• Interaction with packaging, where leachables migrate into the product matrix
• Contamination, from solvents, sample containers, or lab handling
• Column ageing, leading to changes in retention time or peak broadening
• Carryover or matrix effects, especially in complex formulations

These interferences not only distort your data, and they can raise regulatory red flags or disrupt release timelines.

Our Approach to Troubleshooting

At Broughton, our analytical development team applies a structured and science-driven process to resolve chromatographic issues fast:

1. Method Review – We assess whether the peak is truly new, masked previously, or a known degradation product.
2. Stress Testing – We subject the sample to ICH-relevant conditions (light, heat, humidity) to check for breakdown or reaction.
3. Orthogonal Techniques – Using LC–MS/MS, GC–MS, or UV to confirm identity and rule out false positives.
4. Isolated Input Testing – We test excipients, solvents, and packaging materials individually to pinpoint the source.
5. Storage & Handling Review – Evaluating whether the issue arises post-manufacture due to logistics, storage, or transport.

Each step is tailored to the specific product and formulation, ensuring accurate root cause identification and corrective actions.

Why It Matters

Unexplained peaks can cause far more than scientific confusion. They can:

• Delay or derail a PMTA, MAA, or TRPR submission
• Undermine confidence in your product’s stability
• Trigger repeat testing, lost time, and compliance concerns

Resolving these issues quickly helps maintain your regulatory momentum and protects product quality.

How Broughton Supports You

We combine analytical development experience with deep regulatory understanding to help you:

• Investigate and resolve chromatography anomalies
• Optimise and validate analytical methods to reduce variability
• Provide documentation to support root cause and CAPA requirements
• Communicate findings clearly to regulators and QA stakeholders

Learn more about how Broughton supports nicotine product testing and regulatory success. Explore our analytical testing services.