HPHC testing
Aerosol data used data from: https://www.mdpi.com/2297-8739/8/10/168/htm was from a 3% nicotine solution.
Data for acetaldehyde in solution from Chemical evaluation of electronic cigarettes | Tobacco Control (bmj.com), calculation below
Tobacco product HPHC testing results are represented in the PT domain. This example assume testing at a single time point, not serial testing over multiple timepoints as in stability studies. See the Stability Studies section for more information and examples on handling those data.
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| Rows 1-172: | Show the HPHC testing performed on one sample of the product with SPTOBID CIG01a. The test condition is represented in STOCONID. | | Rows 5-6: | Show the same analyte from two different sources | | Rows 14-16: | Show three analytes that were tested in smoke produced by a smoking machine. SPDEVID indicates the smoking machine identified in the DI dataset example below. The smoking regimen is shown in PTREFID. The parameters of the smoking regimen are represented in the DU domain (example below) and are matched by using the same value of DUREFID). Note that PTSPEC (Matrix Type) is "SMOKE" for these 3 records (vs "TOBACCO") for all other records in this dataset. | | for two constituents on Batch 1, Replication 1 for the liquid matrix. The CAS number of the constituent is provided in PTCAS. | | Rows 3-5: | Shows the HPHC testing performed for three constituents using the NON-INTENSE SMOKING REGIME for BATCH 1 and Replicate 1. | | Rows 6-7: | Shows the HPHC testing performed for three constituents using the INTENSE SMOKING REGIME for BATCH 1 and Replicate 1 | Rows 18-19: | Show the HPHC testing performed on one sample for two ingredients using the CANDIAN INTENSE test conditions. Row 18 Specimen is Smoke and Row 19 Specimen is Filler. |
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| Row | STUDYID | DOMAIN | SPTOBID | SPDEVID | PTSEQ | PTREFID | PTSPID | PTCAS | PTTESTCD | PTTEST | PTCAT | PTSCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC | PTMETHOD | PTREPNUM |
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PTTPT | PTTPTNUMTOB07Week 0 | 1 | 2022-09-30 | 10 | HPHC | 11 | TOB08 | PT | ENDS02a | 1 | Batch 101 | CIG01a | 8 | 71-43-2 | BENZN | Benzene | HPHC TESTING | HPHC | 33 | µg/cigarette | 33 | 33 | µg/cigarette | TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | 2 | TOB07 | PT | CIG01a | 9 | 50-32-8 | BENZOAP | Benzo[a]pyrene | HPHC TESTING | HPHC | 6.8 | ng/cigarette | 6.8 | 6.8 | ng/cigarette | TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | 3 | | 4 | TOB07 | PT | CIG01a | PUFFMASTER3K | 15 | Medium Intensity Regimen | 64091-91-4 | NNK | Nicotine-Derived Nitrosamine Ketone | HPHC TESTING | HPHC | 71 | ng/cigarette | 71 | 71 | ng/cigarette | SMOKE | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 5 | TOB07 | PT | CIG01a | PUFFMASTER3K | 16 | Medium Intensity Regimen | 16543-55-8 | NNN | N-nitrosonornicotine | HPHC TESTING | HPHC | 85 | ng/cigarette | 85 | 85 | ng/cigarette | SMOKE | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | 6 | 7 | | DOMAIN | SPTOBID | PTSEQ | PTREFID | PTCSREFID | PTTESTCD | PTTEST | PTCAT | HPHC vs other constituents | PTORRES | Unit | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC | PTMETHOD | PTREPNUM | PTTPT | PTTPTNUM | PTDTC | 8 | PTSCAT | PTORRESU | Week 0 | 1 | 9 | 1954-11-05 | NIC | Nicotine | HPHC TESTING | 3 | mg/mL | 3 | 3 | mg/mL | E-LIQUID | - | 1 | | ENDS02a |
| 1 | Batch 101 | since we started with using PTREFID for the Smoking Regimen in the Cig. example, The batch number could go here. It seems like Smoking Regimen is a method though. |
| 75-07-0 | ACETALD | Acetaldehyde | HPHC TESTING | HPHC | 7.9 | µg/mL | 7.9 | 7.9 | µg/mL | E-LIQUID |
- | Week 01 | 12 | | 2 | TOB08 | PT | ENDS02a | PUFFMASTER3K | 2 | Batch 101 |
| 1954-11-05 | NIC | Nicotine | HPHC TESTING | HPHC | 53.5 | µg/puff | 53.5 | 53.5 | µg/puff | AEROSOL | Non-intense |
1 | Week 013| 3 | TOB08 | PT | ENDS02a | PUFFMASTER3K |
2| 3 | Batch 101 |
| 75-07-0 | ACETALD | Acetaldehyde | HPHC TESTING | HPHC | 34.7 | ng/puff | 34.7 | 34.7 | ng/puff | AEROSOL | Non-intense | 1 | 2022-09-30 |
14 | | 4 | TOB08 | PT | ENDS02a | PUFFMASTER3K | 4 | Batch 101 |
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| Benzoic Acid | HPHC TESTING | Other | 43.3 | µg/puff | 43.3 | 43.3 | µg/puff | AEROSOL | Non-intense | 1 | 2022-09-30 |
15 | | 5 | TOB08 | PT | ENDS02a | PUFFMASTER3K | 5 | Batch 101 |
| 1954-11-05 | NIC | Nicotine | HPHC TESTING | HPHC | 105 | µg/puff | 105 | 105 | µg/puff | AEROSOL | Intense |
116| 6 | TOB08 | PT | ENDS02a | PUFFMASTER3K |
2| 6 | Batch 101 |
| 75-07-0 | ACETALD | Acetaldehyde | HPHC TESTING | HPHC | 43.5 | ng/puff | 43.5 | 43.5 | ng/puff | AEROSOL | Intense |
117| 7 | TOB08 | PT | ENDS02a | PUFFMASTER3K | 7 | Batch 101 |
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| Benzoic Acid | HPHC TESTING | Other | 84.1 | µg/puff | 84.1 | 84.1 | µg/puff | AEROSOL | Intense |
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The identifying characteristics of the smoking machine are represented in the Device Identifiers reference dataset.
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Details of the smoking regimen performed by the smoking machine are represented as device in-use properties, linked to the HPHC testing results in PT above by matching values of PTREFID/DUREFID = "Medium Intensity Non-intense Regimen".
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| Dataset2 |
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| Row | STUDYID | DOMAIN | SPDEVID | DUSEQ | DUREFID | DUGRPID | DUTESTCD | DUTEST | DUORRES | DUORRESU | DUSTRESC | DUSTRESN | DUSTRESU |
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| 1 | TOB07 | DU | PUFFMASTER3K | 1 |
Medium Intensity | Non-intense Regimen |
| PUFFPROF | Puff Profile | SQUARE |
| SQUARE |
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| | 2 | TOB07 | DU | PUFFMASTER3K | 2 |
Medium Intensity | Non-intense Regimen |
| PUFFDUR | Puff Duration | 1.25 | sec | 1.25 | 1.25 | sec | | 3 | TOB07 | DU | PUFFMASTER3K | 3 |
Medium Intensity | Non-intense Regimen |
| PUFFINT | Puff Interval | 3 | PUFF/min | 3 | 3 | PUFF/min | | 4 | TOB07 | DU | PUFFMASTER3K | 4 |
Medium Intensity | Non-intense Regimen |
| PUFFBLCK | Puff Block | 25 | % | 25 | 25 | % | | 5 | TOB07 | DU | PUFFMASTER3K | 5 |
Medium Intensity | Non-intense Regimen |
| NUMPUFF | Total Number of Puffs | 200 | PUFF | 200 | 200 | PUFF | | 6 | TOB07 | DU | PUFFMASTER3K | 6 |
Medium Intensity | Non-intense Regimen |
| PUFFVOL | Puff Volume | 10 | mL | 10 | 10 | mL | | 7 | TOB07 | DU | PUFFMASTER3K | 7 |
Medium Intensity | Non-intense Regimen |
| PUFFRNG | Puff Range | 100-200 |
| 100-200 |
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| | 8 | TOB07 | DU | PUFFMASTER3K | 8 |
Medium Intensity | Non-intense Regimen | 1 | PUFFPAUS | Puff Pause | 60 | s | 60 | 60 | s | | 9 | TOB07 | DU | PUFFMASTER3K | 9 |
Medium Intensity | Non-intense Regimen | 1 | PUFFPINT | Puff Pause Interval | 10 | PUFF | 10 | 10 | PUFF | | 10 | TOB07 | DU | PUFFMASTER3K | 1 | Intense Regimen |
| PUFFPROF | Puff Profile | SQUARE |
| SQUARE |
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| | 11 | TOB07 | DU | PUFFMASTER3K | 2 | Intense Regimen |
| PUFFDUR | Puff Duration | 1.25 | sec | 1.25 | 1.25 | sec | | 12 | TOB07 | DU | PUFFMASTER3K | 3 | Intense Regimen |
| PUFFINT | Puff Interval | 3 | PUFF/min | 3 | 3 | PUFF/min | | 13 | TOB07 | DU | PUFFMASTER3K | 4 | Intense Regimen |
| PUFFBLCK | Puff Block | 25 | % | 25 | 25 | % | | 14 | TOB07 | DU | PUFFMASTER3K | 5 | Intense Regimen |
| NUMPUFF | Total Number of Puffs | 200 | PUFF | 200 | 200 | PUFF | | 15 | TOB07 | DU | PUFFMASTER3K | 6 | Intense Regimen |
| PUFFVOL | Puff Volume | 10 | mL | 10 | 10 | mL | | 16 | TOB07 | DU | PUFFMASTER3K | 7 | Intense Regimen |
| PUFFRNG | Puff Range | 100-200 |
| 100-200 |
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| | 17 | TOB07 | DU | PUFFMASTER3K | 8 | Intense Regimen | 1 | PUFFPAUS | Puff Pause | 10 | s | 10 | 10 | s | | 18 | TOB07 | DU | PUFFMASTER3K | 9 | Intense Regimen | 1 | PUFFPINT | Puff Pause Interval | 20 | PUFF | 20 | 20 | PUFF |
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