ABBREVIATED METHOD FOR TNCOANALYSIS - MODIFIED ISO SMOKING

Rana TayyarahITG Brands, LLCrana.tayyarah@itgbrands.com

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Objective and Success Criteria

ObjectiveDevelop a method for a 2 day reporting of TNCO

Success criteria– 2 day reporting– %RSD no more than 2 x ISO– Applicable to a range of conventional cigarette designs– Applicable to ISO smoking parameters– Applicable to a high volume sample set– Applicable to a comparative analysis study

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Variables Considered

• Conditioning time• Number of Cigarettes • Loose versus packed cigarettes• Standard butt length versus fixed number of puffs

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Sample Types

• Typical American blend cigarette designs• Menthol and Non-Menthol

RangeISO ‘Tar’ (mg/cig) 3 – 17Length (mm) 80 – 100Filter Ventilation (%) 0 – 60

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Method Establishment - Design

• Launch a separate Logistics Project

• Evaluate major variables with a small set of samples

• Robustness for ‘No Conditioning’

• Method Verification - Baseline Data collection over time

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Logistics Project

• Collection and logging simultaneous – for a preview of the samples

• Automated Batch-building• Custom Data Review Report• Automated Reported

• Isolated workflows in the lab

• No Repeat analysis window, but loop back cycle established

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Method Establishment• Conditioning time (0, 24 hours)

• Number of Cigarettes (1-5)

• Loose versus packed cigarettes

• Fixed butt length versus fixed number of puffs

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No Conditioning vs ISO

0.00

1.00

2.00

3.00

4.00

5.00

NC, 1 NC, 2 NC, 3 ISO

mg/

cig

NC – No conditioning, no equilibrium weight, smoked day of making, 3 cigs/pad, ISO butt length

0.00

0.10

0.20

0.30

0.40

NC, 1 NC, 2 NC, 3 ISO

mg/

cig

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Packed vs Loose – No Conditioning

n ‘Tar’ (mg/cig)

Nicotine (mg/cig)

CO (mg/cig)

Packed 91 13.95 ± 0.68 1.00 ± 0.05 15.98 ± 0.88

Loose 96 13.79 ± 0.65 1.00 ± 0.05 15.68 ± 0.91

All Data* 385 13.90 ± 0.68 1.02 ± 0.05 15.92 ± 0.88

ISO Smoking 248 13.92 ± 0.93 1.04 ± 0.06 16.12 ± 1.04

% Difference 0.1% 2.3% 1.3%

*4 cigs/pad, loose or packed cigarettes, Smoked the same day as making with no equilibrium weights using ISO parameters, ISO butt length 9

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6-Puff Variability Comparisons –MS Nicotine

Sample (ISO ‘Tar’) ISO 6 Puff Modified ISO

A – 3 mg 9% 18%, 9%, 5% B – 7 mg 8% 7%C – 14 mg 7% 6%D – 17 mg 7% 6%CM6 4% 4%

Success criteria - %RSD no more than 2x ISO value

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Method Establishment - Results• Conditioning time (0, 24 hours)

– Results were similar, 0 was chosen for baseline study

• Number of Cigarettes (1-5)– Result were similar, 3 cigarettes were chosen for baseline

• Loose versus packed cigarettes– Result were similar, packed was chosen for baseline study

• Fixed butt length versus fixed number of puffs– Both met criteria, fixed butt length was chosen for baseline study

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No Conditioning Questions

• Cigarette Equilibration (Age)

• Seasonal Impact

• Dry/Moist Cigarettes

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Cigarette Equilibration (Short-term Aging)

0

2

4

6

8

10

12

Day 0/1 Day 7 Day 14

‘Tar

’ (m

g/ci

g)

Cigarette Age when Smoked

No Conditioning

24 Hour Conditioning

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Impact of Varied Conditioning %RH

3R4F cigarettes conditioned for 2 weeks at target %RHConditioning temperature = 22◦CSmoking Conditions = 60% RH, 22◦Cn=5

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1011

0% 20% 40% 60% 80% 100%

Yiel

d (m

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ISO-3s'Tar'ISO+3s

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Impact of Varied Conditioning %RH

3R4F cigarettes conditioned for 2 weeks at target %RHConditioning temperature = 22◦CSmoking Conditions = 60% RH, 22◦Cn=5

0.4

0.5

0.6

0.7

0.8

0.9

0% 20% 40% 60% 80% 100%

Yiel

d (m

g/ci

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ISO-3sNicotineISO+3s

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Method Verification

• Full ‘tar’ range for samples• Dry season and humid season*• At least 100 data points per sample over time

(*for North Carolina) 16

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Verification – Exemplary ‘Tar’ Data

02468

101214161820

E F G H I J K L M

Yiel

d (m

g/ci

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ISONew Method

n=40-12017

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Verification – Exemplary Nicotine Data

0

0.2

0.4

0.6

0.8

1

1.2

1.4

E F G H I J K L M

Yiel

d (m

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ISONew Method

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Verification – Exemplary Carbon Monoxide Data

02468

101214161820

E F G H I J K L M

Yiel

d (m

g/ci

g)

ISONew Method

n=40-12019

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Conclusions• A 2 day TNCO method was established with no cigarette conditioning, no

equilibrium test, 3cigs/pad, loose or packed cigarettes, fixed butt length or fixed puff number

• The Modified Method meets the technical success criteria– Two day reportable, <2x ISO-variability, compatible with high volume submission

• Streamlined Laboratory workflows are key to meeting reporting objectives

• Yield results similar to ISO for standard butt length version

• Fixed puff testing would require control chart establishment for monitors

• Scope not extended to lab to lab comparisons, long-term consistency, or alternate regimes

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Acknowledgements

• Sample Control, Routine Testing Services• Brenda Duncan• Francine Hancock• Olabisi Johnson• Michelle Long• Adrian Watson

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