Broughton Nicotine Services 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, therefore we have developed a tailor-made approach for each NGP category.

 

Electronic Nicotine Delivery System (ENDS)

What Analytical Studies involve for ENDS

HPHC Testing

Maintaining regulatory compliance is a key factor in keeping your ENDS products on the market.  Although ENDS are shown to have less adverse effect on human health than traditional combustible tobacco products, harmful and potentially harmful constituents (HPHC’s) may still be produced using these products.

The determination of HPHC’s in an ENDS product is therefore a critical factor to assess the potential health benefits of ENDS relative to the known risks of combustible cigarettes.

We have developed and validated highly sensitive analytical methods capable of operating within a lean laboratory environment to deliver high quality HPHC data within a rapid turnaround time specific for the ENDS industry.

Broughton Nicotine Services offer the full suite of HPHC testing as specified in international guidelines and directives. ln addition, other constituents classified as respiratory irritants are analysed to comply with US PMTA requirements.

Document management is in full compliance with United Kingdom Accreditation Service (UKAS) ISO/IEC 17025:2017, FDA 21 CFR Part 820 and International Conference on Harmonisation (ICH) Q2R2 requirements and records are maintained within a Tobacco Product Master File (TPMF).

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 ENDS products for the determination of the following core HPHC’s listed by FDA:

  • Nicotine
  • Humectants, humectant impurities and menthol
  • Carbonyls (aldehydes & di-ketones)
  • Furfural
  • Metals
  • Tobacco-Specific Nitrosamines (TSNAs)
  • Volatile Organic Compounds (VOCs)
  • Propionic acid
  • Flavor additives
  • Aromatic aldehydes
  • Nicotine related substances
  • pH

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.

Analytical Testing for Stability Studies

Stability storage is provided in dedicated 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 Nicotine Services have 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).

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:

 

High-end Analytical Instruments

Category

HPLC with UV detection

Chromatography

UHPLC with MS/MS detection

Chromatography

GC with FID

Chromatography

GCMS with liquid sampling

Chromatography

GCMS with headspace sampling

Chromatography

GCMS/MS with liquid sampling

Chromatography

IC

Chromatography

ICP-MS

Spectroscopy

 

Other Techniques

Category

CETI-8 e-cig smoking rig

E-cigarette Aerosol Collection

Karl Fisher Moisture

Titration

Melting / boiling point

Physical Characteristics

Particle Size analysis

Physical Characteristics

Density

Physical Characteristics

Viscometry

Physical Characteristics

Refractometry

Physical Characteristics

 

Modern Oral Nicotine Pouches

We have developed tailor-made analytical services including the following methods:

 Method Description

Technique

Analyte(s) 

Water Content

Karl Fischer

Water

Moisture Content /Oven Volatiles

Oven

Loss on Drying 

Metals

ICP-MS

Arsenic

Cadmium

Chromium

Nickel

Lead

Tin

Zinc

Silver

Aluminium

Vanadium

Cobalt

Molybdenum

Antimony

Mercury

Carbonyls

HPLC-MS

Formaldehyde

Acetaldehyde

Acrolein

Crotonaldehyde

MEK (2-butanone)

Butyraldehyde

Di-ketones

HPLC-MS

Diacetyl

Acetyl propionyl 

Nicotine

HPLC-UV

Nicotine 

TSNAs 

HPLC-MS/MS

NNN, NNK, NAT, NAB

Dissolution of Nicotine

USP 4 / HPLC-UV

Nicotine 

Water Activity

Water Activity Meter 

N/A 

Freebase Nicotine

Henderson-Hasselbalch

Freebase: Protonated Nic

Nitrites/Nitrates

IC-UV

Nitrites

Nitrates

Nicotine Related Substances

HPLC-MS/MS

Nicotine-N-oxide

Anabasine

Myosmine

Cotinine

Anatabine

β-nicotyrine

Nornicotine

å

pH

 

 

Benzo[α]pyrene

HR-GC-MS

Benzo[α]pyrene

Benzo[α]anthracene

Benzo[α]fluroanthene

Aflatoxins/Ochratoxins

HPLC-Fluorescence

Aflatoxins B1, B2, G1, G2 and total
Ochratoxin A

Pesticides

LC-MS / GC-MS

Up to 420 pesticides

Micro

Monograph Method

TAMC / TYMC

Micro

 

BET

 

Through our strategic partnerships and extended laboratory network we are able to offer additional services to support your needs. 

Charlie Chats

Proprietary Analytical Data Management Software

Working with our sister company, Broughton Software, Broughton Nicotine Services 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 in a controlled and secure manner.

A fully integrated approach to analytical studies

Broughton Nicotine Services operate exclusively in the NGP sector. 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 advance a smoke free future.

New call-to-action

Resources

Leaflet

Overview of our full-service PMTA compliance solution, from planning through to compilation and submission.

Guide

Understand what’s involved in a PMTA and how the recommendations relate to your ENDS business.

Leaflet

Download our leaflet for an overview of our comprehensive services to support the NGPS industry from regulatory submission to maintaining compliance.