Shelf life study has a protocol and provides the results of shelf life studies of tobacco products over time with different conditions and analytes. Generally there are many conditions with at least two with varying temperature, humidity, etc.
The initial table shows the a number of the analytes and test conditions used in Shelf Life studies for smokeless tobacco products for one testing condition at one timepoint and one replicate. The second table has one analyte and two test conditions for many time points and replicates.
The Tobacco Product Testing (PT) is a Findings domain similar to the Laboratory Test Results domain.
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Row 1: | Shows the PTTEST of Product Moisture which reflects the percentage of moisture in the substance for the condition noted in PTTSTCND which is Condition 1. Product Moisture is sometimes referred to as "Oven Volatiles". | Rows 4, 6, 8: | Show the NNK, NNN, and TSN tests with the tobacco product "as-is" using the PTSPCCND to show that the tobacco is "FRESH". | Rows 5, 7, 9: | Show the NNK, NNN, and TSN tests with the tobacco product as "Dry weight basis (DWB)" using the TTSPCCND to show that the tobacco is "DRIED". | Rows 2-12: | Show the other analytes used in testing (pH, water activity, NNK, NNN, TSNA, etc.) using the PTTEST and PTTESTCD variables. | |
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Row | STUDYID | DOMAIN | SPTOBID | STOCONID | PTSEQ | PTREFID | PTTESTCD | PTTEST | PTCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC | PTSPCCND | PTMETHOD | PTLLOQ | PTREPNUM | PTTPT | PTTPTNUM |
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1 | TOB07 | PT | Smokeless01 | Condition 1 | 1 | TOB77777.1 | PRODMST | Product Moisture | STABILITY STUDY | 52.0 | % | 52.0 | 52.0 | % | TOBACCO |
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| 1 | Week 0 | 1 | 2 | TOB07 | PT | Smokeless01 | Condition 1 | 2 | TOB77777.1 | PH | pH | STABILITY STUDY | 8.06 |
| 8.06 | 8.06 |
| TOBACCO |
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| 1 | Week 0 | 1 | 3 | TOB07 | PT | Smokeless01 | Condition 1 | 3 | TOB77777.1 | H2OACT | Water Activity | STABILITY STUDY | 0.86 |
| 0.86 | 0.86 |
| TOBACCO |
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| 1 | Week 0 | 1 | 4 | TOB07 | PT | Smokeless01 | Condition 1 | 4 | TOB77777.1 | NNK | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) | STABILITY STUDY | 1.0225 | ug/g | 1.0225 | 1.0225 | ug/g | TOBACCO, FRESH | as-is |
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| 1 | Week 0 | 1 | 5 | TOB07 | PT | Smokeless01 | Condition 1 | 5 | TOB77777.1 | NNK | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) | STABILITY STUDY | 0.4908 | ug/g | 0.4908 | 0.4908 | ug/g | TOBACCO, DRIED | dry weight |
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| 1 | Week 0 | 1 | 6 | TOB07 | PT | Smokeless01 | Condition 1 | 6 | TOB77777.1 | NNN | N-nitrosonornicotine | STABILITY STUDY | 4.4633 | ug/g | 4.4633 | 4.4633 | ug/g | TOBACCO, FRESH | as-is |
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| 1 | Week 0 | 1 | 7 | TOB07 | PT | Smokeless01 | Condition 1 | 7 | TOB77777.1 | NNN | N-nitrosonornicotine | STABILITY STUDY | 2.1424 | ug/g | 2.1424 | 2.1424 | ug/g | TOBACCO, DRIED | dry weight |
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| 1 | Week 0 | 1 | 8 | TOB07 | PT | Smokeless01 | Condition 1 | 8 | TOB77777.1 | TSNA | Tobacco-specific nitrosamines | STABILITY STUDY | 7.598 | ug/g | 7.598 | 7.598 | ug/g | TOBACCO, FRESH | as-is |
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| 1 | Week 0 | 1 | 9 | TOB07 | PT | Smokeless01 | Condition 1 | 9 | TOB77777.1 | TSNA | Tobacco-specific nitrosamines | STABILITY STUDY | 3.7453 | ug/g | 3.7453 | 3.7453 | ug/g | TOBACCO, DRIED | dry weight |
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| 1 | Week 0 | 1 | 10 | TOB07 | PT | Smokeless01 | Condition 1 | 10 | TOB77777.1 | AEBPLCT | Aerobic Plate Count | STABILITY STUDY | 154000 | CFU/g | 154000 | 154000 | CFU/g | TOBACCO |
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| 1 | Week 0 | 1 | 11 | TOB07 | PT | Smokeless01 | Condition 1 | 11 | TOB77777.1 | MOLD | Mold | STABILITY STUDY | <10 | CFU/g | <10 | <10 | CFU/g | TOBACCO |
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| 1 | Week 0 | 1 | 12 | TOB07 | PT | Smokeless01 | Condition 1 | 12 | TOB77777.1 | YEAST | Yeast | STABILITY STUDY | <10 | CFU/g | <10 | <10 | CFU/g | TOBACCO |
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| 1 | Week 0 | 1 |
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*DWB=Dry weight basis. The DWB normalizes the results since starting moisture may vary.
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 moisture content using the TEST of Product Moisture (also known as Oven Volatile) percentage 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.
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Rows 1-9: | Show the PTTEST of Product Moisture for Condition 1 which is shown in PTTSTCND. The sample of various timepoints that may be used in the testing for product moisture 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 Product Moisture for Condition 2 across the same timepoints shown for Condition 1. The PTGRPID is used to tie together a block of related records in a single domain. | |
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Row | STUDYID | DOMAIN | SPTOBID | STOCONID | PTSEQ | PTREFID | PTTESTCD | PTTEST | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC | PTSPCCND | PTMETHOD | PTREPNUM | PTTPT | PTTPTNUM |
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1 | TOB07 | PT | Smokeless01 | Condition 1 | 111 | TOB77777.1 | PRODMST | Product Moisture | 51.93 | % | 51.93 | 51.93 | % | TOBACCO | as is |
| 1 | Week 0 | 1 | 2 | TOB07 | PT | Smokeless01 | Condition 1 | 112 | TOB77777.1 | PRODMST | Product Moisture | 51.96 | % | 51.96 | 51.96 | % | TOBACCO | as is |
| 2 | Week 0 | 1 | 3 | TOB07 | PT | Smokeless01 | Condition 1 | 113 | TOB77777.1 | PRODMST | Product Moisture | 51.98 | % | 51.98 | 51.98 | % | TOBACCO | as is |
| 3 | Week 0 | 1 | 4 | TOB07 | PT | Smokeless01 | Condition 1 | 114 | TOB77777.1 | PRODMST | Product Moisture | 51.75 | % | 51.75 | 51.75 | % | TOBACCO | as is |
| 1 | Week 8 | 4 | 5 | TOB07 | PT | Smokeless01 | Condition 1 | 115 | TOB77777.1 | PRODMST | Product Moisture | 51.75 | % | 51.75 | 51.75 | % | TOBACCO | as is |
| 2 | Week 8 | 4 | 6 | TOB07 | PT | Smokeless01 | Condition 1 | 116 | TOB77777.1 | PRODMST | Product Moisture | 51.67 | % | 51.67 | 51.67 | % | TOBACCO | as is |
| 3 | Week 8 | 4 | 7 | TOB07 | PT | Smokeless01 | Condition 1 | 117 | TOB77777.1 | PRODMST | Product Moisture | 52.05 | % | 52.05 | 52.05 | % | TOBACCO | as is |
| 1 | Week 48 | 9 | 8 | TOB07 | PT | Smokeless01 | Condition 1 | 118 | TOB77777.1 | PRODMST | Product Moisture | 52.68 | % | 52.68 | 52.68 | % | TOBACCO | as is |
| 2 | Week 48 | 9 | 9 | TOB07 | PT | Smokeless01 | Condition 1 | 119 | TOB77777.1 | PRODMST | Product Moisture | 52.21 | % | 52.21 | 52.21 | % | TOBACCO | as is |
| 3 | Week 48 | 9 | 10 | TOB07 | PT | Smokeless01 | Condition 2 | 120 | TOB77777.1 | PRODMST | Product Moisture | 51.93 | % | 51.93 | 51.93 | % | TOBACCO | as is |
| 1 | Week 0 | 1 | 11 | TOB07 | PT | Smokeless01 | Condition 2 | 121 | TOB77777.1 | PRODMST | Product Moisture | 51.96 | % | 51.96 | 51.96 | % | TOBACCO | as is |
| 2 | Week 0 | 1 | 12 | TOB07 | PT | Smokeless01 | Condition 2 | 122 | TOB77777.1 | PRODMST | Product Moisture | 51.98 | % | 51.98 | 51.98 | % | TOBACCO | as is |
| 3 | Week 0 | 1 | 13 | TOB07 | PT | Smokeless01 | Condition 2 | 123 | TOB77777.1 | PRODMST | Product Moisture | 51.80 | % | 51.80 | 51.80 | % | TOBACCO | as is |
| 1 | Week 8 | 4 | 14 | TOB07 | PT | Smokeless01 | Condition 2 | 124 | TOB77777.1 | PRODMST | Product Moisture | 51.77 | % | 51.77 | 51.77 | % | TOBACCO | as is |
| 2 | Week 8 | 4 | 15 | TOB07 | PT | Smokeless01 | Condition 2 | 125 | TOB77777.1 | PRODMST | Product Moisture | 51.84 | % | 51.84 | 51.84 | % | TOBACCO | as is |
| 3 | Week 8 | 4 | 16 | TOB07 | PT | Smokeless01 | Condition 2 | 126 | TOB77777.1 | PRODMST | Product Moisture | 52.18 | % | 52.18 | 52.18 | % | TOBACCO | as is |
| 1 | Week 48 | 9 | 17 | TOB07 | PT | Smokeless01 | Condition 2 | 127 | TOB77777.1 | PRODMST | Product Moisture | 52.21 | % | 52.21 | 52.21 | % | TOBACCO | as is |
| 2 | Week 48 | 9 | 18 | TOB07 | PT | Smokeless01 | Condition 2 | 128 | TOB77777.1 | PRODMST | Product Moisture | 51.87 | % | 51.87 | 51.87 | % | TOBACCO | as is |
| 3 | Week 48 | 9 |
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The storage conditions details of "E-Liquid Standard (Long Term) Condition 1" and "E-Liquid Standard (Long Term) Condition 1" are represented in the Environmental Storage Conditions (ES) dataset.
- The variable STOCONID (Storage Condition ID) = "E-Liquid Standard (Long Term) Condition". Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU.
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Row | STUDYID | DOMAIN | STOCONID | ESSEQ | ESPARMCD | ESPARM | ESVAL | ESVALU |
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1 | TOB07 | ES | E-Liquid Standard (Long Term) Condition 1 | 1 | HUMID | Humidity | 37 | % | 2 | TOB07 | ES | E-Liquid Standard (Long Term) Condition 1 | 2 | TEMP | Temperature | 24 | C | 3 | TOB07 | ES | E-Liquid Standard (Long Term) Condition 2 | 1 | HUMID | Humidity | 85 | % | 4 | TOB07 | ES | E-Liquid Standard (Long Term) Condition 2 | 2 | TEMP | Temperature | 27 | C |
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