Introduction

In drug development, speed is everything. Every month of delay in approval can cost a pharma company millions. Yet, one of the most overlooked reasons for regulatory delays is impurities. Not just the obvious ones, but often a single, uncharacterized impurity that seems minor at first glance.

This blog explores real-world lessons from cases where impurities slowed down submissions — and how buyers can prevent history from repeating.

A Costly Delay: The Case of the “Unknown Peak”

A mid-sized pharma company was preparing its ANDA submission for a generic anti-hypertensive. Everything seemed perfect: the dossier was clean, the bioequivalence study was successful, and the market was ready.

But during USFDA review, one issue emerged: a tiny unknown peak in the chromatogram that hadn’t been identified or qualified.

Result? A Complete Response Letter (CRL). Six months lost, millions of dollars in missed revenue, and a demoralized team.

Lesson? Even a single, low-level impurity can derail approvals if it’s not properly studied and reported.

Why It Happens

• Rushed procurement – buyers choose a supplier without verifying the full impurity profile.

• Incomplete COAs – data gaps in reference standards provided by the seller.

• Misalignment with regulatory updates – impurity thresholds evolve, but dossiers often lag.

Buyer’s Checklist to Prevent Delays

1. Always request complete characterization data (NMR, MS, IR, etc.) from suppliers.

2. Verify alignment with current ICH guidelines – especially Q3A/Q3B and M7.

3. Run independent verification of critical impurities before submission.

4. Ensure traceability of reference standards – COA, MSDS, ISO certification.

How Impurityx Helps

On Impurityx, buyers don’t just see a product listing. They see a complete dossier trail, with seller verification, certifications, and buyer reviews. That means fewer “unknown peaks” and more confidence that what you buy today won’t cause a regulatory shock tomorrow.

Closing Thought

In pharma, delays aren’t just expensive — they’re avoidable. With the right due diligence and transparent sourcing, a single impurity never has to stand between you and market success.