Chemistry

Understanding the chemistry of your products

Broughton is a Contract Research Organisation ( CRO ) equipped to offer full analytical services to evaluate the chemistry of nicotine pouches, e-liquids, captured aerosol, devices and all forms of packaging container systems for the NGP industry.

By partnering with us, you will have access to some of the most experienced scientific consultants and chemists who are committed to developing safer nicotine products.

Our team understand the regulatory challenges and unique opportunities within the NGP industry. We will work with you to ensure your current and future products are safe, compliant, and commercially successful. We appreciate that your requirements are not generic, so neither is our approach.

Analytical Studies for ENDS
Analytical studies for ENDS
HPHC testing
Bespoke Analytical Method Development and Validation
Our team of experienced scientists and chemists have partnered with leading equipment manufacturers to offer clients bespoke analytical method development and validation to meet increasing regulatory requirements.
Bespoke analytical method
Analytical Testing for Stability Studies

Stability storage is provided in purpose built walk-in climatic chambers located in a controlled area. The chambers are controlled via a fully validated data management system in accordance with FDA requirements and ICH harmonized guidelines for stability testing of new drug products and substances. Each chamber is temperature and humidity controlled to +/-2°C and +/-5%RH of its target conditions, with 24hr monitoring of chamber conditions.

  • Shelf life Studies – designed to detect the potential degradation of the product that may result in exposure of HPHCs and other toxic chemicals over the lifespan of the product, to keep your customers safe and your brand protected.
  • Accelerated Studies – designed to allow early assessment of stability indicating analytes to build a projection of a product’s potential stability over its desired shelf life. Early knowledge of stability behaviour can be critical in saving cost and time during pre-market regulatory projects.
  • Photostability – analyses the effect of light on the product and product container to help maintain protective measures against photodegradation for product safety.
  • Extractables and Leachables – investigate, identify and monitor the wide variety of compounds that may be present in either the delivery device or the e-liquid; and which may therefore present an exposure risk to your end user.

Broughton has extensive experience of designing ENDS stability studies in support of regulatory applications. Stability studies can be conducted at a number of different temperature and humidity conditions, including real-time, in-use and accelerated conditions in-accordance with ICH Q1A(R2).

  • Shelf Life Studies – designed to detect the potential degradation of the product that may result in exposure of HPHCs and other toxic chemicals over the lifespan of the product, to keep your customers safe and your brand protected
Quality Control (QC) and Batch Release Testing

Our dedicated team will help you manage the quality and safety of your products throughout their lifecycle providing reassurance and support. Batch testing and investigatory analysis guarantees product quality ensuring the protection of public health.

Using a wide range of analytical techniques, we provide QC testing of raw materials and finished products. Our laboratory is equipped with an extensive suite of high-end analytical instruments and aerosol collection rigs.

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Proprietary Analytical Data Management Software
Working with our sister company, Broughton Software, we have created a bespoke version of LabHQ LIMS for the collation, storage and reporting of analytical data. This system is designed and validated in accordance with FDA 21 CFR Part 11 for Electronic Records and Signatures. This system ensures that data is reported in a timely manner and that all raw data is retained and controlled securely.

A fully integrated approach to analytical studies

Our team of scientific and regulatory experts, backed by an in-house custom-built CRO facility, understand your specific challenges and opportunities and are committed to working with you to increase the value of your business and create a smoke free-future.

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