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.
HPHC testing is conducted on samples of the product of interest, and (if applicable) samples of comparison products. Each product tested would have its own unique sponsor-defined value for SPTOBID to identify the product.
This example only shows test results for each constituent for one replicate of one sample of one product that was tested. Details of the sampling and testing plan, including the number of samples of the products tested, are determined by the sponsor or by regulatory requirement. Sponsors would likely have multiple product samples tested in multiple replicates, and those would be distinguished in the dataset.
The following references were used as guidance for the example below:
1. https://www.ecigstats.org/docs/research/CoA_1R6F.pdf
2. https://open.canada.ca/data/en/dataset/71394df3-aee8-4117-92cb-a035360972a2/resource/7e6b0457-051e-4620-befc-8e4f50b75345
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| Rows 1-17: | 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. | | 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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| Dataset2 |
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| Row | STUDYID | DOMAIN | SPTOBID | SPDEVID | PTSEQ | PTREFID | PTCAS | PTTESTCD | PTTEST | PTCAT | PTSCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC | PTMETHOD | PTREPNUM | PTTPT | PTTPTNUM | PTDTC |
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| 1 | TOB07 | PT | CIG01a |
| 1 |
| 75-07-0 | ACETALD | Acetaldehyde | HPHC TESTING | HPHC | 522 | µg/cigarette | 522 | 522 | µg/cigarette | TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 2 | TOB07 | PT | CIG01a |
| 2 |
| 107-02-8 | ACROL | Acrolein | HPHC TESTING | HPHC | 43 | µg/cigarette | 43 | 43 | µg/cigarette | TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 3 | TOB07 | PT | CIG01a |
| 3 |
| 107-13-1 | ACRLONI | Acrylonitrile | HPHC TESTING | HPHC | 7 | µg/cigarette | 7 | 7 | µg/cigarette | TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 4 | TOB07 | PT | CIG01a |
| 4 |
| 92-67-1 | AMNPHEN4 | 4-Aminobiphenyl | HPHC TESTING | HPHC | 1.2 | ng/cigarette | 1.2 | 1.2 | ng/cigarette | TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 5 | TOB07 | PT | CIG01a |
| 5 |
| 134-32-7 | AMNPHTH1 | 1-Aminonaphthalene | HPHC TESTING | HPHC | 14 | ng/cigarette | 14 | 14 | ng/cigarette | TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 6 | TOB07 | PT | CIG01a |
| 6 |
| 134-32-7 | AMNPHTH2 | 2-Aminonaphthalene | HPHC TESTING | HPHC | 8 | ng/cigarette | 8 | 8 | ng/cigarette | TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 7 | TOB07 | PT | CIG01a |
| 7 |
| 7664-41-7 | NH4 | Ammonia | HPHC TESTING | HPHC | 9 | µg/cigarette | 9 | 9 | µg/cigarette | TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 8 | TOB07 | PT | 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 | | 9 | 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 | | 10 | TOB07 | PT | CIG01a |
| 10 |
| 630-08-0 | CO | Carbon monoxide | HPHC TESTING | HPHC | 10.1 | mg/cigarette | 10.1 | 10.1 | mg/cigarette | TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 11 | TOB07 | PT | CIG01a |
| 11 |
| 4170-30-3 | CROTALD | Crotonaldehyde | HPHC TESTING | HPHC | 11 | µg/cigarette | 11 | 11 | µg/cigarette | TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 12 | TOB07 | PT | CIG01a |
| 12 |
| 50-00-0 | FORMALD | Formaldehyde | HPHC TESTING | HPHC | 27 | µg/cigarette | 27 | 27 | µg/cigarette | TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 13 | TOB07 | PT | CIG01a |
| 13 |
| 78-79-5 | ISOPRN | Isoprene | HPHC TESTING | HPHC | 320 | µg/cigarette | 320 | 320 | µg/cigarette | TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 14 | TOB07 | PT | CIG01a | PUFFMASTER3K | 14 | Medium Intensity Regimen | 1954-11-05 | NIC | Nicotine | HPHC TESTING | HPHC | 0.721 | mg/cigarette | 0.721 | 0.721 | mg/cigarette | SMOKE | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 15 | 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 | | 16 | 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 | | 17 | TOB07 | PT | CIG01a |
| 17 |
| 108-88-3 | TOLUENE | Toluene | HPHC TESTING | HPHC | 53 | µg/cigarette | 53 | 53 | µg/cigarette | TOBACCO | ISO METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 18 | TOB07 | PT | CIG01a |
| 18 |
| 75-07-0 | ACETALD | Acetaldehyde | HPHC TESTING | HPHC | 1552 | µg/cigarette | 1552 | 1552 | µg/cigarette | TOBACCO | CANADIAN INTENSE METHOD | 1 | Week 0 | 1 | 2022-09-30 | | 19 | TOB07 | PT | CIG01a |
| 19 |
| 7664-41-7 | AMMONIA | Ammonia | HPHC TESTING | HPHC | 956 | µg/g | 956 | 956 | µg/cigarette | FILLER | CANADIAN INTENSE METHOD | 1 | Week 0 | 1 | 2022-09-30 |
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The identifying characteristics of the smoking machine are represented in the Device Identifiers reference dataset.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL |
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| 1 | TOB07 | DI | PUFFMASTER3K | 1 | DEVTYPE | Device Type | Smoking Machine |
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| 2 | TOB07 | DI | PUFFMASTER3K | 2 | MANUF | Manufacturer | Acme |
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| 3 | TOB07 | DI | PUFFMASTER3K | 3 | TRADENAM | Trade Name | PuffMaster 3000 |
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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 Regimen".
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| Dataset2 |
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| STUDYID | DOMAIN | SPDEVID | DUSEQ | DUREFID | DUGRPID | DUTESTCD | DUTEST | DUORRES | DUORRESU | DUSTRESC | DUSTRESN | DUSTRESU |
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| 1 | TOB07 | DU | PUFFMASTER3K | 1 | Medium Intensity Regimen |
| PUFFPROF | Puff Profile | SQUARE |
| SQUARE |
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| | 2 | TOB07 | DU | PUFFMASTER3K | 2 | Medium Intensity Regimen |
| PUFFDUR | Puff Duration | 1.25 | sec | 1.25 | 1.25 | sec | | 3 | TOB07 | DU | PUFFMASTER3K | 3 | Medium Intensity Regimen |
| PUFFINT | Puff Interval | 3 | PUFF/min | 3 | 3 | PUFF/min | | 4 | TOB07 | DU | PUFFMASTER3K | 4 | Medium Intensity Regimen |
| PUFFBLCK | Puff Block | 25 | % | 25 | 25 | % | | 5 | TOB07 | DU | PUFFMASTER3K | 5 | Medium Intensity Regimen |
| NUMPUFF | Total Number of Puffs | 200 | PUFF | 200 | 200 | PUFF | | 6 | TOB07 | DU | PUFFMASTER3K | 6 | Medium Intensity Regimen |
| PUFFVOL | Puff Volume | 10 | mL | 10 | 10 | mL | | 7 | TOB07 | DU | PUFFMASTER3K | 7 | Medium Intensity Regimen |
| PUFFRNG | Puff Range | 100-200 |
| 100-200 |
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| | 8 | TOB07 | DU | PUFFMASTER3K | 8 | Medium Intensity Regimen | 1 | PUFFPAUS | Puff Pause | 60 | s | 60 | 60 | s | | 9 | TOB07 | DU | PUFFMASTER3K | 9 | Medium Intensity Regimen | 1 | PUFFPINT | Puff Pause Interval | 10 | PUFF | 10 | 10 | PUFF |
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