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PAH Detection via GC-MS

Supporting Regulatory-Driven Excellence in Pharmaceutical and Medical Device Testing

Gateway Analytical specializes in the identification and quantification of polycyclic aromatic hydrocarbons (PAHs), including those originating from carbon black and elastomeric components. Leveraging cutting-edge instrumentation and deep materials expertise, our team develops precise, regulatory-aligned methods to meet your product and compliance requirements.

Choose Gateway for trusted analytical insight and proven excellence across pharmaceutical and medical device industries. Gateway Analytical offers advanced method development and validation for trace-level leachables, genotoxic impurities, and targeted contaminants. Our ISO-accredited lab and expert scientists provide fully customized solutions tailored to your product’s unique matrix and regulatory path. With decades of experience in pharma and medical device analysis, we ensure data integrity, compliance, and product safety from start to finish. Connect with our analytical team today at info@gatewayanalytical.com or (724) 443-1900.

 

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Covering every stage of the drug development journey with our state-of-the-art, FDA-inspected, cGMP-compliant facilities designed to minimize bottlenecks and maximize success.

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Early-Phase Development

Comprehensive packages designed to navigate clinical & regulatory complexities of parenteral product-package and container-closure development, from concept to market readiness.

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Container Closure
Integrity Testing

Quantitative, non-destructive, deterministic leak detection technologies for products stored in vials, syringes, cartridges, flexible containers, and bottles.

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Particulate
Analysis

Multi-analytical methods to count, size, and characterize visible and subvisible particulate matter in pharmaceuticals, disposable containers, single-use systems, raw materials, and medical devices.

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Medical Device
Analysis

Rigorous studies focused on enumerating particulate matter and identifying potential chemical compounds that could migrate from medical devices into the environment or directly impact patient health.

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Extractables
& Leachables

Studies aimed at identifying potentially harmful compounds in manufacturing components and final containers to ensure the safety and efficacy of pharmaceutical products.

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