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DI = TO for Tobacco Product IdentifierIdentifiers and Descriptors SPDEVID = SPTOBID for Sponsor Tobacco Device Product Identifier DO/DU = Tobacco Product Design Parameters (DPPD) LB = Tobacco Product Testing (TT)PT) - [Would Findings be better?] |
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.
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Tobacco Product Testing (TT) is a Findings domain similar to the Laboratory Test Results domain.
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Row 1: | Shows the TTTEST PTTEST of Product Moisture which reflects the percentage of moisture in the substance for the condition noted in TTTSTCND PTTSTCND which is Condition 1 (X°C/ Z% RH). 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 TTSPCCND 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 TTTEST PTTEST and TTTESTCD PTTESTCD variables. | |
Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | TTSEQPTSEQ | TTREFIDPTREFID | TTTESTCDPTTESTCD | TTTESTPTTEST | TTCATPTCAT | TTTSTCNDPTTSTCND | TTORRESPTORRES | TTORRESUPTORRESU | TTSTRESCPTSTRESC | TTSTRESNPTSTRESN | TTSTRESUPTSTRESU | TTSPECPTSPEC | TTSPCCNDPTSPCCND | TTMETHODPTMETHOD | TTLLOQPTLLOQ | TTREPNUMPTREPNUM | TTTPTPTTPT | TTTPTNUMPTTPTNUM |
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1 | TOB07 | TTPT | Cig01a | 1 | TOB77777.1 | PRODMST | Product Moisture | STABILITY STUDY | Condition 1 (X°C/ Z% RH) |
| % |
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| % | TOBACCO |
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| 1 | Week 0 | 1 | 2 | TOB07 | TTPT | Cig01a | 2 | TOB77777.1 | PH | pH | STABILITY STUDY | Condition 1 (X°C/ Z% RH) |
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| TOBACCO |
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| 1 | Week 0 | 1 | 3 | TOB07 | TTPT | Cig01a | 3 | TOB77777.1 | H2OACT | Water Activity | STABILITY STUDY | Condition 1 (X°C/ Z% RH) |
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| TOBACCO |
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| 1 | Week 0 | 1 | 4 | TOB07 | TTPT | Cig01a | 4 | TOB77777.1 | NNK | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) | STABILITY STUDY | Condition 1 (X°C/ Z% RH) |
| ng/g |
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| ng/g | TOBACCO | FRESH |
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| 1 | Week 0 | 1 | 5 | TOB07 | TTPT | Cig01a | 5 | TOB77777.1 | NNK | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) | STABILITY STUDY | Condition 1 (X°C/ Z% RH) |
| ng/g |
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| ng/g | TOBACCO | DRIED |
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| 1 | Week 0 | 1 | 6 | TOB07 | TTPT | Cig01a | 6 | TOB77777.1 | NNN | N-nitrosonornicotine | STABILITY STUDY | Condition 1 (X°C/ Z% RH) |
| ng/g |
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| ng/g | TOBACCO | FRESH |
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| 1 | Week 0 | 1 | 7 | TOB07 | TTPT | Cig01a | 7 | TOB77777.1 | NNN | N-nitrosonornicotine | STABILITY STUDY | Condition 1 (X°C/ Z% RH) |
| ng/g |
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| ng/g | TOBACCO | DRIED |
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| 1 | Week 0 | 1 | 8 | TOB07 | TTPT | Cig01a | 8 | TOB77777.1 | TSNA | Tobacco-specific nitrosamines | STABILITY STUDY | Condition 1 (X°C/ Z% RH) |
| ng/g |
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| ng/g | TOBACCO | FRESH |
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| 1 | Week 0 | 1 | 9 | TOB07 | TTPT | Cig01a | 9 | TOB77777.1 | TSNA | Tobacco-specific nitrosamines | STABILITY STUDY | Condition 1 (X°C/ Z% RH) |
| ng/g |
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| ng/g | TOBACCO | DRIED |
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| 1 | Week 0 | 1 | 10 | TOB07 | TTPT | Cig01a | 10 | TOB77777.1 | AEBPLCT | Aerobic Plate Count | STABILITY STUDY | Condition 1 (X°C/ Z% RH) |
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| TOBACCO |
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| 1 | Week 0 | 1 | 11 | TOB07 | TTPT | Cig01a | 11 | TOB77777.1 | MOLD | Mold | STABILITY STUDY | Condition 1 (X°C/ Z% RH) |
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| TOBACCO |
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| 1 | Week 0 | 1 | 12 | TOB07 | TTPT | Cig01a | 12 | TOB77777.1 | YEAST | Yeast | STABILITY STUDY | Condition 1 (X°C/ Z% RH) |
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| TOBACCO |
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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 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 TTTPTNUM PTTPTNUM of 2,3, etc. are not shown for visual viewing purposes.
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Rows 1-9: | Show the TTTEST PTTEST of Product Moisture for Condition 1 (X°C/ Z% RH) which is shown in TTTSTCNDPTTSTCND. The sample of various timepoints that may be used in the testing for product moisture is reflected in TTTPTPTTPT. The TTTPTNUM 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 TTTEST PTTEST of Product Moisture for Condition 2 Condition 2 (A °C/ B %RH) across the same timepoints shown for Condition 1. The TTGRPID PTGRPID is used to tie together a block of related records in a single domain. | |
Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | TTSEQPTSEQ | TTREFIDPTREFID | TTTESTCDPTTESTCD | TTTESTPTTEST | TTTSTCNDPTTSTCND | TTORRESPTORRES | TTORRESUPTORRESU | TTSTRESCPTSTRESC | TTSTRESNPTSTRESN | TTSTRESUPTSTRESU | TTSPECPTSPEC | TTSPCCNDPTSPCCND | TTMETHODPTMETHOD | TTREPNUMPTREPNUM | TTTPTPTTPT | TTTPTNUMPTTPTNUM |
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1 | TOB07 | TTPT | Cig01a | 111 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) |
| % |
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| % | TOBACCO |
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| 1 | Week 0 | 1 | 2 | TOB07 | TTPT | Cig01a | 112 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) |
| % |
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| % | TOBACCO |
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| 2 | Week 0 | 1 | 3 | TOB07 | TTPT | Cig01a | 113 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) |
| % |
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| % | TOBACCO |
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| 3 | Week 0 | 1 | 4 | TOB07 | TTPT | Cig01a | 114 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) |
| % |
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| % | TOBACCO |
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| 1 | Week 8 | 4 | 5 | TOB07 | TTPT | Cig01a | 115 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) |
| % |
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| % | TOBACCO |
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| 2 | Week 8 | 4 | 6 | TOB07 | TTPT | Cig01a | 116 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) |
| % |
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| % | TOBACCO |
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| 3 | Week 8 | 4 | 7 | TOB07 | TTPT | Cig01a | 117 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) |
| % |
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| % | TOBACCO |
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| 1 | Week 48 | 9 | 8 | TOB07 | TTPT | Cig01a | 118 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) |
| % |
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| % | TOBACCO |
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| 2 | Week 48 | 9 | 9 | TOB07 | TTPT | Cig01a | 119 | TOB77777.1 | PRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) |
| % |
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| % | TOBACCO |
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| 3 | Week 48 | 9 | 10 | TOB07 | TTPT | Cig01a | 120 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) |
| % |
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| % | TOBACCO |
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| 1 | Week 0 | 1 | 11 | TOB07 | TTPT | Cig01a | 121 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) |
| % |
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| % | TOBACCO |
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| 2 | Week 0 | 1 | 12 | TOB07 | TTPT | Cig01a | 122 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) |
| % |
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| % | TOBACCO |
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| 3 | Week 0 | 1 | 13 | TOB07 | TTPT | Cig01a | 123 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) |
| % |
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| % | TOBACCO |
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| 1 | Week 8 | 4 | 14 | TOB07 | TTPT | Cig01a | 124 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) |
| % |
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| % | TOBACCO |
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| 2 | Week 8 | 4 | 15 | TOB07 | TTPT | Cig01a | 125 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) |
| % |
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| % | TOBACCO |
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| 3 | Week 8 | 4 | 16 | TOB07 | TTPT | Cig01a | 126 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) |
| % |
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| % | TOBACCO |
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| 1 | Week 48 | 9 | 17 | TOB07 | TTPT | Cig01a | 127 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) |
| % |
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| % | TOBACCO |
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| 2 | Week 48 | 9 | 18 | TOB07 | TTPT | Cig01a | 128 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) |
| % |
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| % | TOBACCO |
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| 3 | Week 48 | 9 |
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