Tobacco product HPHC testing results are represented in the PT domain. This example assume illustrates HPHC testing and smoking regimens for a cigarette product. The example assumes testing at a single time point, not serial testing over multiple timepoints as in stability studies. See the Section 3.1.4, 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. illustrating how to represent those data.
This example only shows test results for each constituent for one 1 replicate of one 1 sample of one 1 product that was tested (PTREPNUM = 1 for all records). Details of the sampling and testing plan, including the number of samples of the products tested, are determined by the sponsor applicant or by regulatory requirement. Sponsors Applicants 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
by values of PTREPNUM being set to 1 through n, where n = the number of replicates being performed.
Note the use of the PTXFN (external file name) to indicate that the lab methodology was submitted as separate documentation.
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| Rows 1-17: | the 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 from the tobacco product identified in SPTOBID (CIG01a). Note of the use of SPDEVID as the device identifier for the smoking machine and the use of PTREFID to identify the smoking regimen (non-intense regimen). PTSPEC=SMOKE to indicate the specimen type is smoke. | | Row 18: | Shows 1 analyte was tested with a different smoking regimen (PTREFID=INTENSE REGIMEN) using the same smoking machine. | | Row 19: | Shows 1 analyte was tested in the tobacco filler (PTSPEC). Thus SPDEVID and PTREFID are null | 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 |
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PTCAS | PTTESTCD | PTTEST | PTCAT | PTSCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTXFN | PTNAM | PTSPEC |
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PTMETHODPTTPT | PTTPTNUM | PTDTC |
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| 1 | TOB07 | PT | CIG01a | PUFFMASTER3K | 1 |
75-07-0 | ACETALD| NON-INTENSE REGIMEN | ACTALD | Acetaldehyde | HPHC TESTING | HPHC | 522 |
µgµgTOBACCO | ISO METHOD | 1 | Week 0 | | TL001_V5.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 2 | TOB07 | PT | CIG01a | PUFFMASTER3K | 2 |
107-02-8 | ACROL| NON-INTENSE REGIMEN | ACROLEIN | Acrolein | HPHC TESTING | HPHC | 43 |
µgµgTOBACCO | ISO METHOD | 1 | | TL002_V3.6.pdf | TPT LABCO | SMOKE |
Week 0 | 1 | 2022-09-30 | | 3 | TOB07 | PT | CIG01a | PUFFMASTER3K | 3 |
107-13-1 | ACRLONI| NON-INTENSE REGIMEN | ACRYNTRL | Acrylonitrile | HPHC TESTING | HPHC | 7 |
µgµgTOBACCO | ISO METHOD | 1 | | TL006_V6.pdf | TPT LABCO | SMOKE |
Week 0 | 1 | 2022-09-30 | | 4 | TOB07 | PT | CIG01a | PUFFMASTER3K | 4 |
92-67-1 | AMNPHEN4| NON-INTENSE REGIMEN | ABP4 | 4-Aminobiphenyl | HPHC TESTING | HPHC | 1.2 | ng/cigarette | 1.2 | 1.2 | ng/cigarette |
TOBACCO | ISO METHOD | 1 | Week 0 | | TL008_V3.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 5 | TOB07 | PT | CIG01a | PUFFMASTER3K | 5 |
134-32-7| NON-INTENSE REGIMEN | AMNPHTH1 | 1-Aminonaphthalene | HPHC TESTING | HPHC | 14 | ng/cigarette | 14 | 14 | ng/cigarette |
TOBACCO | ISO METHOD | 1 | | TL003_V1.4.pdf | TPT LABCO | SMOKE |
Week 0 | 1 | 2022-09-30 | | 6 | TOB07 | PT | CIG01a | PUFFMASTER3K | 6 |
134-32-7| NON-INTENSE REGIMEN | AMNPHTH2 | 2-Aminonaphthalene | HPHC TESTING | HPHC | 8 | ng/cigarette | 8 | 8 | ng/cigarette |
TOBACCO | ISO METHOD | 1 | Week 0 | | TL003_V1.4.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 7 | TOB07 | PT | CIG01a | PUFFMASTER3K | 7 |
7664-41-7 | NH4| NON-INTENSE REGIMEN | AMMONIA | Ammonia | HPHC TESTING | HPHC | 9 |
µgµgTOBACCO | ISO METHOD | 1 | Week 0 | | TL020_V4.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 8 | TOB07 | PT | CIG01a | PUFFMASTER3K | 8 |
71-43-2 | BENZN| NON-INTENSE REGIMEN | BENZENE | Benzene | HPHC TESTING | HPHC | 33 |
µgµgTOBACCO | ISO METHOD | 1 | | TL017_V1.1.pdf | TPT LABCO | SMOKE |
Week 0 | 1 | 2022-09-30 | | 9 | TOB07 | PT | CIG01a | PUFFMASTER3K | 9 |
50-32-8 | BENZOAP| NON-INTENSE REGIMEN | BZAPYR | Benzo[a]pyrene | HPHC TESTING | HPHC | 6.8 | ng/cigarette | 6.8 | 6.8 | ng/cigarette |
TOBACCO | ISO METHOD | 1 | Week 0 | | TL017_V1.1.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 10 | TOB07 | PT | CIG01a | PUFFMASTER3K | 10 |
630-08-0 | | NON-INTENSE REGIMEN | CMONOX |
CO monoxide| Monoxide | HPHC TESTING | HPHC | 10.1 | mg/cigarette | 10.1 | 10.1 | mg/cigarette |
TOBACCO | ISO METHOD | 1 | Week 0 | | TL019_V3.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 11 | TOB07 | PT | CIG01a | PUFFMASTER3K | 11 |
4170-30-3 | CROTALD| NON-INTENSE REGIMEN | CROTNALD | Crotonaldehyde | HPHC TESTING | HPHC | 11 |
µgµgTOBACCO | ISO METHOD | 1 | | TL001_V5.pdf | TPT LABCO | SMOKE |
Week 0 | 1 | 2022-09-30 | | 12 | TOB07 | PT | CIG01a | PUFFMASTER3K | 12 |
50-00-0| NON-INTENSE REGIMEN | FORMALD | Formaldehyde | HPHC TESTING | HPHC | 27 |
µgµgTOBACCO | ISO METHOD | 1 | | TL001_V5.pdf | TPT LABCO | SMOKE |
Week 0 | 1 | 2022-09-30 | | 13 | TOB07 | PT | CIG01a | PUFFMASTER3K | 13 |
78-79-5 | ISOPRN| NON-INTENSE REGIMEN | ISOPRENE | Isoprene | HPHC TESTING | HPHC | 320 |
µgµgTOBACCO | ISO METHOD | 1 | | TL041_V1.pdf | TPT LABCO | SMOKE |
Week 0 | 1 | 2022-09-30 | | 14 | TOB07 | PT | CIG01a | PUFFMASTER3K | 14 |
Medium Intensity Regimen | 1954-11-05 | | NON-INTENSE REGIMEN | NICOTINE |
NIC | Nicotine | HPHC TESTING | HPHC | 0.721 | mg/cigarette | 0.721 | 0.721 | mg/cigarette |
SMOKE | ISO METHOD | 1 | Week 0 | 64091-91-4| TL007_V2.1.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 15 | TOB07 | PT | CIG01a | PUFFMASTER3K | 15 |
Medium Intensity Regimen | | NON-INTENSE REGIMEN | NNK | Nicotine-Derived Nitrosamine Ketone | HPHC TESTING | HPHC | 71 | ng/cigarette | 71 | 71 | ng/cigarette |
SMOKE | ISO METHOD | 1 | Week 0 | 16543-55-8| TL026_V12.2.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 16 | TOB07 | PT | CIG01a | PUFFMASTER3K | 16 |
Medium Intensity Regimen | nitrosonornicotine| Nitrosonornicotine | HPHC TESTING | HPHC | 85 | ng/cigarette | 85 | 85 | ng/cigarette |
SMOKE | ISO METHOD | 1 | | TL026_V12.2.pdf | TPT LABCO | SMOKE |
Week 0 | 1 | 2022-09-30 | | 17 | TOB07 | PT | CIG01a | PUFFMASTER3K | 17 |
108-88-3| NON-INTENSE REGIMEN | TOLUENE | Toluene | HPHC TESTING | HPHC | 53 |
µgµgTOBACCO | ISO METHOD | 1 | Week 0 | | TL011_V3.3.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 18 | TOB07 | PT | CIG01a | PUFFMASTER3K | 18 |
75-07-0 | ACETALD | Acetaldehyde | HPHC TESTING | HPHC | 1552 |
µgµgTOBACCO | CANADIAN INTENSE METHOD | 1 | Week 0 | | TL009_V4.3.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 19 | TOB07 | PT | CIG01a |
| 19 |
7664-41-7 |
| AMMONIA | Ammonia | HPHC TESTING | HPHC | 956 |
µgµgFILLER | CANADIAN INTENSE METHOD | 1 | | TL016_V1.2.pdf | TPT LABCO | TOBACCO FILLER |
Week 0 |
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The identifying characteristics of the smoking machine are represented in the Device Identifiers reference dataset. DI is the source of the applicant-defined device ID variable (SPDEVID) used in the PT dataset to indicate the smoking machine used to perform the smoking regimen.
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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 , (such as settings) of the smoking machine. They are 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 smoking 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 smoking regimen pauses for 60 seconds every 10 puffs. | | Rows 10-18: | Show the parameters of the intense smoking 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 smoking regimen pauses for 30 seconds every 10 puffs. |
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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 | 1Medium Intensity Regimen | NON-INTENSE REGIMEN |
| PUFFPROF | Puff Profile | SQUARE |
| SQUARE |
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| | 2 | TOB07 | DU | PUFFMASTER3K | 2Medium Intensity Regimen | NON-INTENSE REGIMEN |
| PUFFDUR | Puff Duration | 1.25 | sec | 1.25 | 1.25 | sec | | 3 | TOB07 | DU | PUFFMASTER3K | 3Medium Intensity Regimen | NON-INTENSE REGIMEN |
| PUFFINT | Puff Interval | 3 | PUFF/min | 3 | 3 | PUFF/min | | 4 | TOB07 | DU | PUFFMASTER3K | 4Medium Intensity Regimen | NON-INTENSE REGIMEN |
| PUFFBLCK | Puff Block | 25 | % | 25 | 25 | % | | 5 | TOB07 | DU | PUFFMASTER3K | 5 | Medium Intensity Regimen | NUMPUFF | NON-INTENSE REGIMEN |
| | Total Number of Puffs | 200 | PUFF | 200 | 200 | PUFF | | 6 | TOB07 | DU | PUFFMASTER3K | 6Medium Intensity Regimen | NON-INTENSE REGIMEN |
| PUFFVOL | Puff Volume | 10 | mL | 10 | 10 | mL | | 7 | TOB07 | DU | PUFFMASTER3K | 7Medium Intensity Regimen | NON-INTENSE REGIMEN |
| PUFFRNG | Puff Range | 100-200 |
| 100-200 |
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| | 8 | TOB07 | DU | PUFFMASTER3K | 8Medium 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 | 2.25 | sec | 2.25 | 2.25 | 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 | 30 | % | 30 | 30 | % | | 14 | TOB07 | DU | PUFFMASTER3K | 5 | INTENSE REGIMEN |
| PUFFNUM | Number of Puffs | 100 | PUFF | 100 | 100 | PUFF | | 15 | TOB07 | DU | PUFFMASTER3K | 6 | INTENSE REGIMEN |
| PUFFVOL | Puff Volume | 20 | mL | 20 | 20 | mL | | 16 | TOB07 | DU | PUFFMASTER3K | 7 | INTENSE REGIMEN |
| PUFFRNG | Puff Range | 50-150 |
| 50-150 |
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| | 17 | TOB07 | DU | PUFFMASTER3K | 8 | INTENSE REGIMEN | 2 | PUFFPAUS | Puff Pause | 30 | s | 30 | 30 | s | | 18 | TOB07 | DU | PUFFMASTER3K | 9 | INTENSE REGIMEN | 21 | PUFFPINT | Puff Pause Interval | 10 | PUFF | 10 | 10 | PUFF |
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