Impurity Analysis

Impurity Identification and Characterization

Bioanalytical Services Banner

Impurity Identification and Characterization

Characterization, quantitation, and control of impurities are key activities for any pharmaceutical discovery and development program. At Emery Pharma, we are the experts in analyzing impurities at low levels in drug substances and products across various drug modalities (small molecules, peptides, biologics, etc.).

Our services range from residual solvent analysis, process-related impurities, extractables/leachables, forced degradation/stability studies, to assessing genotoxic impurity load in a product. Our team will serve as your partners to deliver customized method development and validation by the FDA, ICH, EMA, and other global regulatory bodies.

There are three types of impurities

Impurity Identification And Characterization Graphic
Impurity Identification Icon 2

Organic impurities

Organic impurities typically arise during drug manufacturing or storage

Impurity Identification Icon 2

Inorganic impurities

Inorganic impurities typically arise during drug manufacturing and include things like reagents, catalysts, heavy metals, or inorganic salts

Impurity Identification Icon 3

Residual solvents

Residual solvents are typically introduced during the preparation of the drug substance

Impurities Testing for Pharmaceutical APIs and Drug Products

Emery Pharma offers comprehensive support in identifying and characterizing impurities in drug substances and drug products. We can perform stability testing, followed by method development, and method validation for quantitation of the impurity. We have extensive experience analyzing various formulations such as oral, topical, IV, rectal products, etc.

Since 2018, several impurities have been highlighted by the FDA as an area of concern. These include:

Our Solutions

High-Resolution Mass Spectrometry

High-resolution mass spectrometry offers an orthogonal perspective to structure elucidation data (as compared to NMR) related to unknown impurity characterization. HRMS provides accurate mass data that are highly resolved, allowing for computation of the molecular composition for an unknown entity.

Why regulatory agencies are concerned about impurities?

The two major concerns surrounding drug impurities are:

  1. That they may cause a drug substance to degrade (thereby reducing its efficacy or safety)
  2. The impurities (or their effects on the drug substance) may be harmful to patients. This was seen in the cases of NDMA and Benzene contamination in consumer products.

FDA Guidelines

The FDA requires that all starting materials and final drug products be evaluated for “identity, strength, quality, and purity.” The FDA has implemented the ICH Q3C guideline which outlines guidelines for residual solvents.