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Rows 1-12: | Shows several analytes (as noted in the PTTEST) in the E-Liquid substance for the condition noted in PTTSTCND which is E-Liquid Standard (Long Term) Condition. | Row 13: | Show microbials used in testing (aerobic plate count, mold, and yeast) using the PTTEST and PTTESTCD variable in the E-Liquid substance for the condition noted in PTTSTCND which is E-Liquid Standard (Long Term) Condition. |
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Dataset2 |
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Row | STUDYID | DOMAIN | PTSEQ | PTREFID | SPTOBID | PTTESTCD | PTTEST | PTCAT | PTSCAT | PTTSTCND | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC | PTSPCCND | PTMETHOD | PTLLOQ | PTREPNUM | PTTPT | PTTPTNUM |
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1 | TOB07 | PT | 1 | VAP77777.1 | 111 | NIC | Nicotine | STABILITY STUDY |
| E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 2 | TOB07 | PT | 2 | VAP77777.1 | 111 | XXXXX | Nicotine Degredants - add a few | | STABILITY STUDY | Nicotine Degredant | E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 3 | TOB07 | PT | 2 | VAP77777.1 | 111 | XXXXX | | STABILITY STUDY | Nicotine DegredantSTABILITY STUDY | E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 34 | TOB07 | PT | 3 | VAP77777.1 | 111 | XXXXX | GlycerinGlycerol | STABILITY STUDY | Primary Ingredient | E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 45 | TOB07 | PT | 3 | VAP77777.1 | 111 | XXXXX | Propylene Glycol | STABILITY STUDY | Primary Ingredient | E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 56 | TOB07 | PT | 4 | VAP77777.1 | 111 | XXXXXAcids | Benzoic Acid | STABILITY STUDY | Organic compounds | E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 67 | TOB07 | PT | 4 | VAP77777.1 | 111 | RXN | Reaction Product | STABILITY STUDY | Organic compounds | E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 78 | TOB07 | PT | 6 | VAP77777.1 | 111 | XXXXX | Menthol
| STABILITY STUDY | Flavorant | E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 9 | TOB07 | PT | 6 | VAP77777.1 | 111 | XXXXX | Vanillin - add Menthol
| STABILITY STUDY | Flavorant | E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 810 | TOB07 | PT | 6 | VAP77777.1 | 111 | XXXXXX | Flavorant
Nicotine salt solution | STABILITY STUDY | Flavorant | E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 911 | TOB07 | PT | 8 | VAP77777.1 | 111 | NNK | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) | STABILITY STUDY | HPHC | E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 12 | TOB07 | PT | 8 | VAP77777.1 | 111 | NNN | N-nitrosonornicotine | STABILITY STUDY | HPHC | XXXXX | HPHC | STABILITY STUDY | E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 1013 | TOB07 | PT | 10 | VAP77777.1 | 111 | XXXXX | Metals - Nickel | STABILITY STUDY | Extractables / Leachables | E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 14 | TOB07 | PT | 10 | VAP77777.1 | 111 | XXXXX | Antioxidants | STABILITY STUDY | Extractables / Leachables | E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 1115 | TOB07 | PT | 11 | VAP77777.1 | 111 | XXXXX | Non targeted compounds | STABILITY STUDY |
| E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 1216 | TOB07 | PT | 12 | VAP77777.1 | 111 | XXXXX | Potential Combustion Products | STABILITY STUDY |
| E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 1317 | TOB07 | PT | 12 | VAP77777.1 | 111 | PH | pH | STABILITY STUDY |
| E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 18 | TOB07 | PT | 12 | VAP77777.1 | 111 | XXXXX | Endotoxin | STABILITY STUDY | Toxins | E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 19 | TOB07 | PT | 12 | VAP77777.1 | 111 | XXXXX | TAMC | STABILITY STUDY | Microbiological | E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | 2014 | TOB07 | PT | 12 | VAP77777.1 | 111 | XXXXX | microbiologicalTYMC | STABILITY STUDY | Microbiological | E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 |
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...
A Shelf Life study dataset would shows analytes done in different test conditions with replicates over time points. In the interest of brevity for this example, only portions of the content using the TEST of Nicotine is shown in a sample of timepoints in two conditions with replicates. The weeks reflective of Week 1, Week 2, Week 3, etc. which would align with the PTTPTNUM of 2,3, etc. are not shown for visual viewing purposes. This is an example, this provides possible tests that might be used to demonstrate how to use the datasets and variables to show what was done for the shelf-life stability study. It shows what timepoint and what type of data follows. It is important to show different test conditions for each analyte. For aerosol a machine similutaion is use so mg/cartridge is valid.
Dataset wrap |
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Rowcaps |
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Rows 1-9: | Show the PTTEST of Nicotine for E-Liquid Standard (Long Term) Condition which is shown in PTTSTCND. The sample of various timepoints that may be used in the testing for Nicotine is reflected in PTTPT. The PTTPTNUM shows the numerical version of the planned timepoint. The REPNUM shows the incidence number of a test that is repeated within a given timeframe for the same test. | Rows 10-18: | Show the PTTEST of Nicotine for E-Liquid Accelerated Aging Condition across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain. | Rows 19-28: | Show the PTTEST of Nicotine for E-Vapor Standard Aerosol Condition across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain. | Rows 29-36: | Show the PTTEST of Nicotine for E-Vapor Intense Aerosol Condition across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain. |
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Dataset2 |
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Row | | DOMAIN | PTSEQ | PTREFID | PTGRPID | PTTESTCD | PTTEST | PTTSTCND | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC | PTSPCCND | PTMETHOD | PTREPNUM | PTTPT | PTTPTNUM |
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1 | TOB07 | PT | 211 | VAP77777.1 | 1 | NIC | | E-Liquid Standard (Long Term) Condition | % |
| mg/mL |
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| mg/mL% | E-LIQUID |
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| 1 | Week 0 | 1 | 2 | TOB07 | PT | 212 | VAP77777.1 | 1 | | Nicotine | E-Liquid Standard (Long Term) Condition | % |
| mg/mL |
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| mg/mL% | E-LIQUID |
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| 2 | Week 0 | 1 | 3 | TOB07 | PT | 213 | VAP77777.1 | 1 | NIC | Nicotine | E-Liquid Standard (Long Term) Condition | % |
| mg/mL |
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| mg/mL% | E-LIQUID |
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| 3 | Week 0 | 1 | 4 | TOB07 | PT | 214 | VAP77777.1 | 1 | NIC | Nicotine | E-Liquid Standard (Long Term) Condition | % |
| mg/mL |
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| mg/mL% | E-LIQUID |
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| 1 | Week 824 | 4 | 5 | TOB07 | PT | 215 | VAP77777.1 | 1 | NIC | Nicotine | E-Liquid Standard (Long Term) Condition | % |
| mg/mL |
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| mg/mL% | E-LIQUID |
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| 2 | Week 824 | 4 | 6 | TOB07 | PT | 216 | VAP77777.1 | 1 | NIC | Nicotine | E-Liquid Standard (Long Term) Condition | % |
| mg/mL |
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| mg/mL% | E-LIQUID |
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| 3 | Week 824 | 4 | 7 | TOB07 | PT | 217 | VAP77777.1 | 1 | NIC | Nicotine | E-Liquid Standard (Long Term) Condition | % |
| mg/mL |
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| mg/mL% | E-LIQUID |
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| 1 | Week 4852 | 9 | 8 | TOB07 | PT | 218 | VAP77777.1 | 1 | NIC | Nicotine | E-Liquid Standard (Long Term) Condition | % |
| mg/mL |
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| mg/mL% | E-LIQUID |
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| 2 | Week 4852 | 9 | 9 | TOB07 | PT | 219 | VAP77777.1 | 1 | NIC | Nicotine | E-Liquid Standard (Long Term) Condition | % |
| mg/mL |
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| mg/mL% | E-LIQUID |
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| 3 | Week 4852 | 9 | 10 | TOB07 | PT | 220 | VAP77777.1 | 2 | NIC | Nicotine | E-Liquid Accelerated Aging Condition | % | % | E-LIQUID | 1 | Week 0 | 1 | 11 | TOB07 | PT | 221 | VAP77777.1 | 2 | NIC | Nicotine | E-Liquid Accelerated Aging Condition | % | % | E-LIQUID | 2 | Week 0 | 1 | 12 | TOB07 | PT | 222 | VAP77777.1 | 2 | NIC | Nicotine | E-Liquid Accelerated Aging Condition | % | % | E-LIQUID | 3 | Week 0 | 1 | 13 | TOB07 | PT | 223 | VAP77777.1 | 2 | NIC | Nicotine | E-Liquid Accelerated Aging Condition | % | % | E-LIQUID | 1 | Week 8 | 4 | 14 | TOB07 | PT | 224 | VAP77777.1 | 2 | NIC | Nicotine | E-Liquid Accelerated Aging Condition | % | % | E-LIQUID | 2 | Week 8 | 4 | 15 | TOB07 | PT | 225 | VAP77777.1 | 2 | NIC | Nicotine | E-Liquid Accelerated Aging Condition | % | % | E-LIQUID | 3 | Week 8 | 4 | 16 | TOB07 | PT | 226 | VAP77777.1 | 2 | NIC | Nicotine | E-Liquid Accelerated Aging Condition | % | % | E-LIQUID | 1 | Week 48 | 9 | 17 | TOB07 | PT | 227 | VAP77777.1 | 2 | NIC | Nicotine | E-Liquid Accelerated Aging Condition | % | % | E-LIQUID | 2 | Week 48 | 9 | 18 | TOB07 | PT | 228 | VAP77777.1 | 2 | NIC | Nicotine | E-Liquid Accelerated Aging Condition | % | % | E-LIQUID | 3 | Week 48 | 9 | 19 | TOB07 | PT | 229 | VAP77777.1 | 3 | NIC | | E-Vapor Standard Aerosol Condition | % |
| mg/cartridge |
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| mg/puff% | E-LIQUID |
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| 1 | Week 0 | 1 | 2011 | TOB07 | PT | 230 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition | % |
| mg/cartridge |
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| mg/cartridge% | E-LIQUID |
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| 2 | Week 0 | 1 | 2112 | TOB07 | PT | 231 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition | % |
| mg/cartridge |
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| mg/cartridge% | E-LIQUID |
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| 3 | Week 0 | 1 | 2213 | TOB07 | PT | 232 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition | % |
| mg/cartridge |
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| mg/cartridge% | E-LIQUID |
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| 1 | Week 824 | 4 | 2314 | TOB07 | PT | 233 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition | % |
| mg/cartridge |
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| mg/cartridge% | E-LIQUID |
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| 2 | Week 824 | 4 | 2415 | TOB07 | PT | 234 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition | % |
| mg/cartridge |
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| mg/cartridge% | E-LIQUID |
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| 3 | Week 824 | 4 | 2516 | TOB07 | PT | 235 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition | % |
| mg/cartridge |
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| mg/cartridge% | E-LIQUID |
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| 1 | Week 4852 | 9 | 2617 | TOB07 | PT | 236 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition | % |
| mg/cartridge |
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| mg/cartridge% | E-LIQUID |
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| 2 | Week 4852 | 9 | 2718 | TOB07 | PT | 237 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition | % |
| mg/cartridge |
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| mg/cartridge% | E-LIQUID |
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| 3 | Week 4852 | 9 | 2819 | TOB07 | PT | 238 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition | % |
| mg/cartridge |
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| mg/cartridge% | E-LIQUID |
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| 1 | Week 0 | 1 | 2920 | TOB07 | PT | 239 | VAP77777.1 | 4 | NIC | Nicotine | E-Vapor Intense Aerosol Condition | % |
| mg/cartridge |
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| mg/cartridge% | E-LIQUID |
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| 2 | Week 0 | 1 | 3021 | TOB07 | PT | 240 | VAP77777.1 | 4 | NIC | Nicotine | E-Vapor Intense Aerosol Condition | % |
| mg/cartridge |
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| mg/cartridge% | E-LIQUID |
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| 3 | Week 0 | 1 | 3122 | TOB07 | PT | 241 | VAP77777.1 | 4 | NIC | Nicotine | E-Vapor Intense Aerosol Condition | % |
| mg/cartridge |
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| mg/cartridge% | E-LIQUID |
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| 1 | Week 824 | 4 | 3223 | TOB07 | PT | 242 | VAP77777.1 | 4 | NIC | Nicotine | E-Vapor Intense Aerosol Condition | % |
| mg/cartridge |
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| mg/cartridge% | E-LIQUID |
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| 2 | Week 824 | 4 | 3324 | TOB07 | PT | 243 | VAP77777.1 | 4 | NIC | Nicotine | E-Vapor Intense Aerosol Condition | % |
| mg/cartridge |
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| mg/cartridge% | E-LIQUID |
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| 3 | Week 824 | 4 | 3425 | TOB07 | PT | 244 | VAP77777.1 | 4 | NIC | Nicotine | E-Vapor Intense Aerosol Condition | % |
| mg/cartridge |
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| mg/cartridge% | E-LIQUID |
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| 1 | Week 4852 | 9 | 3526 | TOB07 | PT | 245 | VAP77777.1 | 4 | NIC | Nicotine | E-Vapor Intense Aerosol Condition | % |
| mg/cartridge |
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| mg/cartridge% | E-LIQUID |
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| 2 | Week 4852 | 9 | 3627 | TOB07 | PT | 246 | VAP77777.1 | 4 | NIC | Nicotine | E-Vapor Intense Aerosol Condition | % |
| mg/cartridge |
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| mg/cartridge% | E-LIQUID |
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| 3 | Week 4852 | 9 |
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