Tobacco 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.shows HPHC testing with an ENDS device.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 sponsorapplicant-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
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| Rows Row 1-17: | Show Shows 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 acetaldehyde from a sample of e-Liquid (as indicated by PTSPEC=E-LIQUID). | | Rows 2-4: | Show the HPHC testing performed for 3 analytes from aerosol produced using the non-intense regimen on a smoking machine. PTSPEC=AEROSOL, SPDEVID indicates the smoking machine used to produce the aerosol, and PTREFID indicates the vaping regimen. | | Rows 5-7: | Show the HPHC testing performed for 3 analytes using the intense regimen on the same smoking machine (PTREFID=INTENSE REGIMEN) | 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 |
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PTCAS | | PTTESTCD | PTTEST | PTCAT | PTSCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC |
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PTMETHOD | PTTPTPTTPTNUM | 1 | 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 | 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 | 1Week 0 | 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 | Week 0 | 1 | 2022-09-30 | 10 | HPHC | 11 | 2022-09-30 | Batch 101 | 75-07-0 | ACETALD |
| ACTALD | Acetaldehyde | HPHC TESTING | HPHC | 7.9 | µg/mL | 7.9 | 7.9 | µg/mL | E-LIQUID |
- | 1 | Week 012 | | 2 | TOB08 | PT | ENDS02a | PUFFMASTER3K | 2 |
1954-11-05 | | NON-INTENSE REGIMEN | NICOTINE |
NIC | Nicotine | HPHC TESTING | HPHC | 53.5 | µg/puff | 53.5 | 53.5 | µg/puff | AEROSOL |
Non-intenseWeek 0 | 1 | 13| 3 | TOB08 | PT | ENDS02a | PUFFMASTER3K |
2 | Batch 101 | 75-07-0 | | 3 | NON-INTENSE REGIMEN | ACTALD |
ACETALD | Acetaldehyde | HPHC TESTING | HPHC | 34.7 | ng/puff | 34.7 | 34.7 | ng/puff | AEROSOL |
Non-intense | 14 | | 4 | TOB08 | PT | ENDS02a | PUFFMASTER3K | 4 | NON-INTENSE REGIMEN | BNZOICAC | Benzoic Acid | HPHC TESTING | Other | 43.3 | µg/puff | 43.3 | 43.3 | µg/puff | AEROSOL |
Non-intense15| 5 | TOB08 | PT | ENDS02a | PUFFMASTER3K |
1954-11-05 | NIC | Nicotine | HPHC TESTING | HPHC | 105 | µg/puff | 105 | 105 | µg/puff | AEROSOL |
Intense1 | 16| 6 | TOB08 | PT | ENDS02a | PUFFMASTER3K |
2Batch 101 | 75-07-0 | ACETALD | Acetaldehyde | HPHC TESTING | HPHC | 43.5 | ng/puff | 43.5 | 43.5 | ng/puff | AEROSOL |
Intense1 | 171 | | 7 | TOB08 | PT | ENDS02a | PUFFMASTER3K | 7 | INTENSE REGIMEN | BNZOICAC | 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 DI 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 vaping 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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| Rows 1-9: | Show the parameters of the non-intense vaping regimen. | | Rows 8-9: | Note the use of DUGRPID to group these records together to indicate that puff pause and puff pause interval are related records. Taken together, they indicate that this vaping regimen pauses for 60 seconds every 10 puffs. | | Rows 10-18: | Show the parameters of the intense vaping regimen. | | Rows 17-18: | Note the use of DUGRPID to group these records together to indicate that puff pause and puff pause interval are related records. Taken together, they indicate that this vaping regimen pauses for 30 seconds every 10 puffs. |
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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 Regimen| NON-INTENSE REGIMEN |
| PUFFPROF | Puff Profile | SQUARE |
| SQUARE |
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| | 2 | TOB07 | DU | PUFFMASTER3K | 2 |
Medium Intensity Regimen| NON-INTENSE REGIMEN |
| PUFFDUR | Puff Duration | 1.25 | sec | 1.25 | 1.25 | sec | | 3 | TOB07 | DU | PUFFMASTER3K | 3 |
Medium Intensity Regimen| NON-INTENSE REGIMEN |
| PUFFINT | Puff Interval |
333| 7 | PUFF/min | | 4 | TOB07 | DU | PUFFMASTER3K | 4 |
Medium Intensity Regimen| NON-INTENSE REGIMEN |
| PUFFBLCK | Puff Block | 25 | % | 25 | 25 | % | | 5 | TOB07 | DU | PUFFMASTER3K | 5 |
Medium Intensity Regimen | NUMPUFF | Total | NON-INTENSE REGIMEN |
| | Number of Puffs | 200 | PUFF | 200 | 200 | PUFF | | 6 | TOB07 | DU | PUFFMASTER3K | 6 |
Medium Intensity Regimen| NON-INTENSE REGIMEN |
| PUFFVOL | Puff Volume | 10 | mL | 10 | 10 | mL | | 7 | TOB07 | DU | PUFFMASTER3K | 7 |
Medium Intensity Regimen| NON-INTENSE REGIMEN |
| PUFFRNG | Puff Range | 100-200 |
| 100-200 |
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| | 8 | TOB07 | DU | PUFFMASTER3K | 8 |
Medium Intensity Regimen| NON-INTENSE REGIMEN | 1 | PUFFPAUS | Puff Pause | 60 | s | 60 | 60 | s | | 9 | TOB07 | DU | PUFFMASTER3K | 9 |
Medium Intensity Regimen| NON-INTENSE REGIMEN | 1 | PUFFPINT | Puff Pause Interval | 10 | PUFF | 10 | 10 | PUFF | | 10 | TOB07 | DU | PUFFMASTER3K | 1 | INTENSE REGIMEN |
| PUFFPROF | Puff Profile | SQUARE |
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| | 11 | TOB07 | DU | PUFFMASTER3K | 2 | INTENSE REGIMEN |
| PUFFDUR | Puff Duration | 3.25 | sec | 3.25 | 3.25 | sec | | 12 | TOB07 | DU | PUFFMASTER3K | 3 | INTENSE REGIMEN |
| PUFFINT | Puff Interval | 10 | PUFF/min | 10 | 10 | PUFF/min | | 13 | TOB07 | DU | PUFFMASTER3K | 4 | INTENSE REGIMEN |
| PUFFBLCK | Puff Block | 25 | % | 25 | 25 | % | | 14 | TOB07 | DU | PUFFMASTER3K | 5 | INTENSE REGIMEN |
| PUFFNUM | Number of Puffs | 300 | PUFF | 300 | 300 | PUFF | | 15 | TOB07 | DU | PUFFMASTER3K | 6 | INTENSE REGIMEN |
| PUFFVOL | Puff Volume | 25 | mL | 25 | 25 | mL | | 16 | TOB07 | DU | PUFFMASTER3K | 7 | INTENSE REGIMEN |
| PUFFRNG | Puff Range | 100-400 |
| 100-400 |
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| | 17 | TOB07 | DU | PUFFMASTER3K | 8 | INTENSE REGIMEN | 2 | PUFFPAUS | Puff Pause | 10 | s | 10 | 10 | s | | 18 | TOB07 | DU | PUFFMASTER3K | 9 | INTENSE REGIMEN | 2 | PUFFPINT | Puff Pause Interval | 30 | PUFF | 30 | 30 | PUFF |
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