Molecular Barcode

Introduction

Barcode and benchmark in one. Deep insight into the molecular core of your product

With Molecular Barcoding from Triskelion, you get both a detailed barcode of your complex product and a direct comparison with the batches or benchmarks of your choice. This gives you insights you cannot generate in-house, while saving time, resources and costs. It allows you to make better decisions about product quality, consistency and development — with confidence backed by science. Whether you’re optimising production, validating sameness or investigating anomalies, we help you uncover what’s hidden and translate complexity into clarity.

What is Molecular Barcode, and why does it matter?

Molecular barcode refers to the use of holistic chemical profiles or intrinsic signatures to characterise samples. Instead of focusing on individual, known compounds, this method captures the complete pattern of small molecules, metabolites or impurities present in your product. This allows you to distinguish between batches, detect adulteration, monitor stability or verify product sameness.

Each product has a unique molecular fingerprint. By comparing these fingerprints across batches or against reference materials, you can support quality decisions, trace deviations and build evidence that your product is what you claim it to be. This is especially relevant when subtle differences matter or when targeted methods fall short.

What does the regulatory or scientific context say?

Although molecular barcode is not explicitly required by regulation, it is increasingly recognised in scientific publications, industry best practices and advanced quality systems. It complements traditional analytical and regulatory methods by providing additional insight into the overall chemical profile.

Regulatory authorities expect you to justify claims, support product equivalence and investigate anomalies. Molecular barcode helps you do exactly that. It provides additional data to strengthen dossiers, support internal quality assurance and respond to audits when targeted analysis cannot explain observed differences.

What does this mean in practice?

Molecular barcode becomes relevant when
• sample differences must be distinguished beyond targeted analytes
• adulteration, mixing or counterfeit risk is suspected
• batch variation or formulation drift must be tracked
• sameness must be demonstrated without known markers

The challenge is that molecular fingerprints are complex and multivariate. Extracting meaning requires high-resolution data, advanced chemometric tools and deep domain knowledge. Without this, the value of the data often remains untapped or difficult to defend.

How we support your Molecular Barcode workflows

Triskelion provides a complete, science-driven service that combines laboratory excellence with regulatory understanding.

  • Analytical techniques: we use high-resolution LC-MS, GC-MS and untargeted screening platforms to create detailed molecular profiles
    • Data interpretation: our experts apply advanced chemometric and statistical models to extract relevant patterns from complex datasets
    • Regulatory and strategic support: we help you use barcode data to support QA documentation, comparability arguments and dossier justifications
    • Clear reporting: you receive audit-ready reports with actionable conclusions that support faster decision-making

Our approach ensures you do not just get more data, but real answers that fit your quality and compliance framework.

Frequently asked questions

Is molecular barcode mandatory?
Not formally, but it is a valuable addition when existing methods cannot fully support your quality or compliance needs.

Can it replace targeted testing?
No. It complements your targeted testing by revealing broader differences or confirming equivalence at the fingerprint level.

Does it require expert interpretation?
Yes. That is why we deliver both the data and the expert guidance to turn it into usable insights.

Want to explore Molecular Barcode?

We help you detect what is hidden, validate what matters and document it clearly.

Contact us for a free intake or proposal tailored to your product, process or question.