Impurity Testing and Control

Control impurity risks at trace levels

Trace impurities, whether elemental, organic, or process-related, can pose significant regulatory and patient safety risks if not properly understood and controlled. Our impurities testing services provide the sensitive, GMP-compliant data needed to demonstrate control across raw materials, in-process formulations, and finished products.

Backed by experienced analytical scientists and robust quality systems, we support impurity programs aligned with evolving regulatory expectations. From routine monitoring to complex investigations, our teams apply advanced instrumentation, validated methodologies, and practical regulatory insight to help you mitigate risk, support submissions, and maintain confidence throughout the product lifecycle.

Our impurities testing services include:

Elemental impurities testing: Trace metals analysis aligned with USP <232>, USP <233>, EP 5.20, and EP 2.4.20 requirements.
Nitrosamine impurities testing: Sensitive testing to detect and quantify nitrosamine impurities and support regulatory risk mitigation strategies.
Residual solvent testing: Identification and quantitation of residual solvents to demonstrate process control and product safety.
Raw materials and finished goods support: Testing across APIs, excipients, in-process materials, and finished pharmaceutical products.
Container closure systems and manufacturing: Extractables and leachables with USP <1663>, USP <1664>, USP <665>, and USP <1665>.
Method development and validation: Custom, phase-appropriate methods to address novel products, evolving guidance, or unique matrices.

USP <467> Residual Solvents Compendial Verifications

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Elemental and trace impurities capabilities

Our laboratories offer full-service elemental and trace impurity testing, combining flexible sample preparation techniques with highly sensitive analytical instrumentation.

Elemental Metals Testing

We test for both beneficial minerals and inorganic impurities arising from raw materials, manufacturing processes, or environmental contamination to deliver accurate data across a wide range of product types.

Extractables and Leachables

We offer extractable and leachable testing spanning product types, delivery systems, and packaging components. With various spectral library references, our testing identifies volatile, semi-volatile, and non-volatile compounds with confidence, plus the ability to determine degradants and perform cross-referencing.

Extractable characterization
Controlled extraction studies
Component and material evaluations
Leachable screening (migration) studies
Manufacturing risk assessments
Leachable stability studies

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Nitrosamines Testing

Nitrosamine impurities are a class of compounds considered probable human carcinogens. These compounds are subject to various FDA, EMA, and other regulatory requirements typically requiring levels below an allowable intake limit between 26.5 and 1500 ng/day depending on the specific nitrosamine. All drug products are subject to the new regulatory testing requirements including commercial products and products that were submitted prior to the issuance of the regulatory guidance. In order to avoid routine testing of the drug products, regulatory guidelines require the level to be less than 10% or 2.5 -150 ng/day (allowable intake level).

Analytical Instrumentation

ICP-MS: Ultra-trace elemental analysis and regulatory-driven impurity testing
Atomic absorption spectroscopy: Flame AA, graphite-furnace AA (GFAA) and cold-vapor AA (CVAA)
Ion chromatography (IC): Low-level anion and cation analysis

Extractables, Leachables, And Risk: Ensuring Safety In Pharma Manufacturing

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Secure Data Accessibility

PacePort is our secure client data access portal; a web-based data delivery system that allows you to access to methods, specifications, reports, and other information at any time, from any location. The materials available via PacePort are of sufficient quality to be used during audits.

Portal access

Analytical testing to help you move forward and stay ahead

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Whether you’re shaping early plans or preparing to scale, our teams are here to help you move forward with clarity and confidence. Start the conversation and we’ll get back to you quickly.

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