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This example only shows test results for each constituent for one replicate of one sample of one 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 or by regulatory requirement. Sponsors would likely have multiple product samples tested in multiple replicates, and those would be distinguished in the dataset 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: | Show HPHC testing performed 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 one analyte was tested with a different smoking regimen ( intense regimenPTREFID=INTENSE REGIMEN) using the same smoking machine. | Row 19: | Shows one analyte was tested in the tobacco filler (PTSPEC). Thus SPDEVID and PTREFID are null. |
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Row | STUDYID | DOMAIN | SPTOBID | SPDEVID | PTSEQ | PTREFID | PTCAS | PTTESTCD | PTTEST | PTCAT | PTSCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTXFN | PTNAM | PTSPEC | PTREPNUM | PTDTC |
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1 | TOB07 | PT | CIG01a | PUFFMASTER3K | 1 | NON-INTENSE REGIMEN | 75-07-0 | ACTALD | Acetaldehyde | HPHC TESTING | HPHC | 522 | ug/cigarette | 522 | 522 | ug/cigarette | TL001_V5.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 2 | TOB07 | PT | CIG01a | PUFFMASTER3K | 2 | NON-INTENSE REGIMEN | 107-02-8 | ACROLEIN | Acrolein | HPHC TESTING | HPHC | 43 | ug/cigarette | 43 | 43 | ug/cigarette | TL002_V3.6.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 3 | TOB07 | PT | CIG01a | PUFFMASTER3K | 3 | NON-INTENSE REGIMEN | 107-13-1 | ACRYNTRL | Acrylonitrile | HPHC TESTING | HPHC | 7 | ug/cigarette | 7 | 7 | ug/cigarette | TL006_V6.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 4 | TOB07 | PT | CIG01a | PUFFMASTER3K | 4 | NON-INTENSE REGIMEN | 92-67-1 | ABP4 | 4-Aminobiphenyl | HPHC TESTING | HPHC | 1.2 | ng/cigarette | 1.2 | 1.2 | ng/cigarette | TL008_V3.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 5 | TOB07 | PT | CIG01a | PUFFMASTER3K | 5 | NON-INTENSE REGIMEN | 134-32-7 | AMNPHTH1 | 1-Aminonaphthalene | HPHC TESTING | HPHC | 14 | ng/cigarette | 14 | 14 | ng/cigarette | TL003_V1.4.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 6 | TOB07 | PT | CIG01a | PUFFMASTER3K | 6 | NON-INTENSE REGIMEN | 134-32-7 | AMNPHTH2 | 2-Aminonaphthalene | HPHC TESTING | HPHC | 8 | ng/cigarette | 8 | 8 | ng/cigarette | TL003_V1.4.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 7 | TOB07 | PT | CIG01a | PUFFMASTER3K | 7 | NON-INTENSE REGIMEN | 7664-41-7 | AMMONIA | Ammonia | HPHC TESTING | HPHC | 9 | ug/cigarette | 9 | 9 | ug/cigarette | TL020_V4.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 8 | TOB07 | PT | CIG01a | PUFFMASTER3K | 8 | NON-INTENSE REGIMEN | 71-43-2 | BENZENE | Benzene | HPHC TESTING | HPHC | 33 | ug/cigarette | 33 | 33 | ug/cigarette | TL017_V1.1.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 9 | TOB07 | PT | CIG01a | PUFFMASTER3K | 9 | NON-INTENSE REGIMEN | 50-32-8 | BZAPYR | Benzo[a]pyrene | HPHC TESTING | HPHC | 6.8 | ng/cigarette | 6.8 | 6.8 | ng/cigarette | TL017_V1.1.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 10 | TOB07 | PT | CIG01a | PUFFMASTER3K | 10 | NON-INTENSE REGIMEN | 630-08-0 | CMONOX | Carbon Monoxide | HPHC TESTING | HPHC | 10.1 | mg/cigarette | 10.1 | 10.1 | mg/cigarette | TL019_V3.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 11 | TOB07 | PT | CIG01a | PUFFMASTER3K | 11 | NON-INTENSE REGIMEN | 4170-30-3 | CROTNALD | Crotonaldehyde | HPHC TESTING | HPHC | 11 | ug/cigarette | 11 | 11 | ug/cigarette | TL001_V5.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 12 | TOB07 | PT | CIG01a | PUFFMASTER3K | 12 | NON-INTENSE REGIMEN | 50-00-0 | FORMALD | Formaldehyde | HPHC TESTING | HPHC | 27 | ug/cigarette | 27 | 27 | ug/cigarette | TL001_V5.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 13 | TOB07 | PT | CIG01a | PUFFMASTER3K | 13 | NON-INTENSE REGIMEN | 78-79-5 | ISOPRENE | Isoprene | HPHC TESTING | HPHC | 320 | ug/cigarette | 320 | 320 | ug/cigarette | TL041_V1.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 14 | TOB07 | PT | CIG01a | PUFFMASTER3K | 14 | NON-INTENSE REGIMEN | 1954-11-05 | NICOTINE | Nicotine | HPHC TESTING | HPHC | 0.721 | mg/cigarette | 0.721 | 0.721 | mg/cigarette | TL007_V2.1.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 15 | TOB07 | PT | CIG01a | PUFFMASTER3K | 15 | NON-INTENSE REGIMEN | 64091-91-4 | NNK | Nicotine-Derived Nitrosamine Ketone | HPHC TESTING | HPHC | 71 | ng/cigarette | 71 | 71 | ng/cigarette | TL026_V12.2.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 16 | TOB07 | PT | CIG01a | PUFFMASTER3K | 16 | NON-INTENSE REGIMEN | 16543-55-8 | NNN | N-Nitrosonornicotine | HPHC TESTING | HPHC | 85 | ng/cigarette | 85 | 85 | ng/cigarette | TL026_V12.2.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 17 | TOB07 | PT | CIG01a | PUFFMASTER3K | 17 | NON-INTENSE REGIMEN | 108-88-3 | TOLUENE | Toluene | HPHC TESTING | HPHC | 53 | ug/cigarette | 53 | 53 | ug/cigarette | TL011_V3.3.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 18 | TOB07 | PT | CIG01a | PUFFMASTER3K | 18 | INTENSE REGIMEN | 75-07-0 | ACTALD | Acetaldehyde | HPHC TESTING | HPHC | 1552 | ug/cigarette | 1552 | 1552 | ug/cigarette | TL009_V4.3.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | 19 | TOB07 | PT | CIG01a | PUFFMASTER3K | 19 |
| 7664-41-7 | AMMONIA | Ammonia | HPHC TESTING | HPHC | 956 | ug/g | 956 | 956 | ug/cigarette | TL016_V1.2.pdf | TPT LABCO | TOBACCO FILLER | 1 | 2022-09-30 |
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