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HPHC Testing
for Nicotine Products

Precision Testing for Harmful and Potential Harmful Constituents (HPHCs) 

Understanding potentially harmful chemicals and the toxicological impact of your nicotine product is essential for marketing authorization. We provide accredited, accurate, and flexible testing for all stages of product development, regulatory submission, and post-launch support.

scientist working with test tubes

 Why is HPHC Testing Important?

Harmful and Potentially Harmful Constituents (HPHCs) are one of the critical quality attributes of next generation nicotine delivery products. Understanding and controlling these constituents is vital in developing, launching, and maintaining your NGP on the market. As a manufacturer, you must understand the potential risks of your NGPs and ensure they comply with regulatory standards and safety guidance.

The determination of HPHCs is a critical factor in assessing the potential health benefits of NGPs relative to the known risks of smoking combustible cigarettes and are a mandatory requirement for regulatory pathways such as Premarket Tobacco Product Application (PMTA) submissions.

We Have Extensive Nicotine Industry Experience 

Our HPHC testing service covers the following NGP  product categories.

  • E-liquids
  • E-cigarettes (ENDS)
  • Heated Tobacco Devices
  • Modern Oral Nicotine Pouches
  • New Nicotine Delivery Innovations
  • Nicotine Replacement Therapies

    Speak to a scientific consultant about your NGP product roadmap and learn how we can help accelerate your products to market and meet your regulatory requirements.

 

 Speak to a scientific consultant

various generic vape devices

Our HPHC Testing Service

With over 15 years of experience working with global NGP manufacturers, we have extensive experience providing HPHC analytical testing for a wide range of NGP product categories. We have developed and validated robust and highly sensitive analytical methods and operate within ISO17025 and GMP accredited laboratory environments appropriate for whichever regulatory pathway you wish to follow. Our scientists deliver high-quality HPHC data with industry-leading turnaround times.

Work with an HPHC analytical testing partner that guarantees accuracy at high levels of sensitivity and selectivity through techniques such as ICP-MS, LC-MS/MS, GC-MS to ensure complete characterization of your product.

We offer the full suite of HPHC testing as specified in international guidelines and directives, including the U.S. Food and Drug Administration (FDA), World Health Organization (WHO), and the Medicines and Healthcare products Regulatory Agency (MHRA).

 

  • ISO Parameters
  • Nicotine
  • Nicotine-related substances
  • Humectants
  • Humectant degradants and impurities
  • Carbonyls
  • Metals
  • Tobacco-Specific Nitrosamines (TSNAs)
  • Volatile Organic Compounds (VOCs)
  • Organic Acids
  • Flavor additives
  • Nitrogen Oxides
  • Phenols
  • Acid Derivatives
  • Di-ketones
  • PAHs

Other non-routine HPHC methods are available upon request as well as a highly-skilled method development to test none routine analytes.

We Deliver a Differentiated HPHC Testing Service 

Experienced in Developing Bespoke NGP Analytical Methods

Our scientists are highly skilled in developing and validating analytical methods to meet global regulatory requirements. We have extensive experience working across a wide range of NGP products for the determination of the core HPHCs listed by global regulatory authorities and can rapidly develop bespoke methods to assess HPHCs for individual product designs.

A Fully Integrated Service Across Analytical Testing and Scientific Consultancy

Benefit from the added reassurance of access to a fully integrated service team across analytical testing and scientific consultancy. When potential risk areas or unexpected results are uncovered, our highly experienced scientific consultants are on-hand to help analyze test data and troubleshoot with your in-house team. 

 

ISO Certified Document Management and Records Maintained in a Tobacco Product Master File (TPMF)

All methodology for U.S. regulatory submissions, and the associated validation documents, are maintained within a Tobacco Product Master File (TPMF) that has been reviewed by FDA in support of products that have been granted marketing orders under the PMTA pathway.

Our document management complies with United Kingdom Accreditation Service (UKAS) ISO/IEC 17025:2017, FDA 21 CFR Part 820, and International Conference on Harmonization ICH (Q2)R1 requirements. 

 

Nicotine Testing Services Resources  

Learn more about how we can help bring your nicotine delivery product to market through our high-quality analytical testing services.

Whitepaper:-Nicotine-Pouches:-An-Extraordinary-Opportunity-to-support-Tobacco-Harm-Reduction

Whitepaper: Nicotine Pouches: An Extraordinary Opportunity to support Tobacco Harm Reduction

There is no doubt that the reduced-risk industry today is at an impasse, although there is now common acceptance that combustible cigarettes are the most hazardous form of nicotine delivery due to the accompanying harmful chemicals produced from tobacco combustion.

Click to download

PMTA-Guide-For-NGP-businesses

PMTA Guide For NGP businesses

At Broughton, our consultants have deep industry knowledge across all the elements required for a PMTA. We guide you through and generate the required data, to ensure that FDA finds your applications strong and compelling.

 

Click to download

A-Guide-To-TPD-and-TRPR

A Guide To TPD and TRPR

An overview of the Tobacco Products Directive and Tobacco-Related Products Regulations. Get the straightforward answers you’re looking for when it comes to TPD and TRPR analysis.

Click to download

Next-Generation-Nicotine-Products-Service-Guide

Next Generation Nicotine Products Service Guide

We help companies of all sizes through the product lifecycle stages, from concept innovation, product realization, and regulatory submission to post marketing surveillance. 

Click to download

Strategic-Insights-to-reignite-PMTA-confidence

Strategic Insights to reignite PMTA confidence

Broughton share their thoughts on how to reduce costs and protect timelines while continuing to innovate.

Click to download

Nicotine Industry Insight and Expert Opinion

Learn more about our activities and gain insight from our scientific and regulatory experts

Visit the blog

Speak to an Expert 

Arrange a meeting with a scientific or regulatory expert to discuss your project and learn how we can help to maximize your success.



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