Polyaromatic Hydrocarbon Profiling Testing
The pharmaceutical industry is heavily regulated to ensure product safety and efficacy. Polyaromatic hydrocarbons (PAHs) are a group of chemicals that can be present in pharmaceutical products, potentially leading to adverse health effects if not properly characterized and controlled.
Our laboratory specializes in providing comprehensive PAH profiling testing services to meet the stringent requirements of the pharmaceutical sector. This service ensures that all polyaromatic hydrocarbons present in your product are identified, quantified, and reported on in compliance with international standards such as ISO 18537-2:2016.
PAHs can form during various stages of drug development, including synthesis, purification, formulation, and packaging. They may also be introduced through impurities or by-products from excipients, solvents, or processing equipment. The presence of PAHs in pharmaceutical products is a significant concern due to their potential carcinogenicity and mutagenicity.
Our testing process begins with thorough sample preparation, which involves extracting the PAHs using appropriate techniques such as liquid-liquid extraction (LLE) or solid-phase extraction (SPE). The extracts are then analyzed using advanced chromatographic methods like high-performance liquid chromatography (HPLC), gas chromatography-mass spectrometry (GC-MS), and ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS).
Once the PAHs are identified, they are quantified using standard curves prepared from authentic standards. The results are reported in parts per million (ppm) or parts per billion (ppb), depending on the sensitivity required by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Our laboratory adheres to strict quality control measures, ensuring accurate and reliable results. We use state-of-the-art instrumentation, including Agilent 1290 Infinity II LC System coupled with a 6410B Mass Selective Detector or Thermo Scientific QQQ mass spectrometer, to provide precise data.
By offering this service, we help pharmaceutical companies comply with regulatory requirements and ensure that their products are safe for consumers. This testing is crucial in maintaining the integrity of your product and protecting public health.
Why It Matters
PAHs can be present at trace levels in pharmaceutical products, but even low concentrations have been linked to several adverse effects. Regulatory bodies such as the FDA and EMA mandate that all PAHs must be identified and quantified during drug development.
The presence of PAHs in a drug product could lead to potential health risks if not managed effectively. They are known carcinogens, and their accumulation over time may pose significant dangers to patients. Therefore, thorough testing is essential to ensure the safety of your product.
Compliance with regulatory standards is critical for maintaining market access and reputation. Non-compliance can result in product recalls, legal action, and loss of trust from consumers. Our service helps you stay ahead of these challenges by providing accurate and reliable PAH profiling reports.
Customer Impact and Satisfaction
Our customers benefit from our comprehensive PAH profiling testing in several ways:
- We provide timely results, ensuring that your product can be released to market on schedule.
- Our rigorous quality control measures ensure accurate and reliable data, which is critical for regulatory approval.
- We offer personalized services tailored to meet the specific needs of your organization. This includes customized sample preparation protocols based on the nature of your raw materials or intermediates.
Customer satisfaction is our top priority. We work closely with you throughout the testing process, providing regular updates and ensuring that all questions are answered promptly. Our goal is to help you achieve compliance while minimizing disruptions to your production schedule.
Use Cases and Application Examples
- New Drug Approval (NDA) Applications: PAH profiling testing is required as part of the FDA's New Drug Application process. Our service ensures that all PAHs are identified and quantified, meeting regulatory requirements.
- Formulation Development: During formulation development, it is essential to identify any potential sources of PAHs in the final product. Our testing can help you optimize your formulation to minimize these impurities.
- Process Validation: In process validation studies, PAH profiling helps ensure that manufacturing processes do not introduce unwanted PAHs into the drug substance or product.
- Batch Release: Before releasing a batch of pharmaceutical product to market, it must be tested for PAH content. Our testing ensures that each batch meets stringent quality standards before release.
- Quality Control Audits: Regulatory authorities may request PAH profiling data as part of routine inspections or audits. Our service provides reliable and reproducible results to support these audits.
