Impurity Identification and Characterization
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 experts in analyzing impurities, metabolites, and active pharmaceutical ingredients (APIs) 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, and forced degradation/stability studies, to assessing and managing the risk of nitrosamine formation in your drug product.
Our team will serve as your partner to deliver customized method development and validation in accordance with FDA, ICH, EMA, and other global regulatory bodies.
There are three types of impurities
Organic impurities
Organic impurities typically arise during drug manufacturing or storage
Inorganic impurities
Inorganic impurities typically arise during drug manufacturing and include things like reagents, catalysts, heavy metals, or inorganic salts
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:
- That they may cause a drug substance to degrade (thereby reducing its efficacy or safety)
- 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.