Analytical testing to identify impurities in a drug substance
Pharmaceutical Service

Evaluation of Impurities

Identifying, qualifying, and assessing impurities and degradation products against the limits regulators accept.

What is Evaluation of Impurities?

This involves the identification, qualification, and toxicological assessment of impurities and degradation products found in drug substances and products — including genotoxic impurities, elemental impurities, and process-related contaminants.

Assessments are conducted in accordance with ICH guidelines (Q3A, Q3B, Q3C, Q3D, M7) to establish acceptable limits and ensure patient safety throughout the product's shelf life.

Scientist examining a sample under a microscope to identify and qualify pharmaceutical impurities
Why it matters

What is in the product matters as much as the product itself.

  • ✦ Genotoxic impurities require some of the tightest limits in pharmaceutical development.
  • ✦ Elemental and process-related contaminants must be tracked from raw material to finished product.
  • ✦ Acceptable limits are set against ICH Q3A/B/C/D and M7, not arbitrary thresholds.
  • ✦ Patient safety must hold throughout the product's full shelf life, not just at release.
What's included

Methodologies we apply

Genotoxic Impurity Assessment

Evaluating DNA-reactive impurities against ICH M7.

Elemental Impurity Analysis

Assessing metal and elemental contaminants per ICH Q3D.

Degradation Product Review

Identifying and qualifying breakdown products over shelf life.

Shelf-Life Safety Evaluation

Confirming acceptable limits hold for the product's full lifecycle.

Standards we align to
ICH Q3A/B/C/D ICH M7 FDA Guidance EMA Guidance
How we assess it

Our process for Evaluation of Impurities

1

Identify Impurities Present

Analytical data is reviewed to identify all relevant impurities.

2

Qualify Against ICH Limits

Each impurity is qualified against ICH Q3A/B/C/D and M7 thresholds.

3

Assess Toxicological Risk

A toxicological risk conclusion is drawn for each impurity.

4

Document Acceptable Limits

Acceptable limits are documented for regulatory submission.

The deliverable

What you receive

A full impurity profile with qualification against ICH limits.

A toxicological risk conclusion for each impurity identified.

Shelf-life safety documentation ready for submission.

Direct access to the assessment team for follow-up questions.

Explore other services
Hazard Identification Exposure Assessment Regulatory Submissions Pharmacovigilance Support Medical Device Services

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