Tobacco product HPHC testing results are represented in the PT domain. This example 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 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 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.
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| 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 1 analyte was tested with a different smoking regimen ( intense regimenPTREFID=INTENSE REGIMEN) using the same smoking machine. | | Row 19: | Shows one 1 analyte was tested in the tobacco filler (PTSPEC). Thus SPDEVID and PTREFID are null. |
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | SPTOBID | SPDEVID | PTSEQ | PTREFID |
|---|
PTCAS | | PTTESTCD | PTTEST | PTCAT | PTSCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTXFN | PTNAM | PTSPEC | PTREPNUM | PTDTC |
|---|
| 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 |
PUFFMASTER3K7664-41-7 |
| AMMONIA | Ammonia | HPHC TESTING | HPHC | 956 | ug/g | 956 | 956 | ug/cigarette | TL016_V1.2.pdf | TPT LABCO | TOBACCO FILLER | 1 | 2022-09-30 |
|
|
The identifying characteristics of the smoking machine are represented in the Device Identifiers reference dataset. DI is the source of the sponsorapplicant-defined device ID variable (SPDEVID) used in the PT dataset to indicate the smoking machine used to perform the smoking regimen.
...
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.
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Rows 1-9: | Show the parameters of the non-intense smoking regimen. | | Rows 8-9: | Note the use of PTGRPID DUGRPID to group these records together to indicate that puff pause and puff pause interval are related records. Taken together, they tell us 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 PTGRPID DUGRPID to group these records together to indicate that puff pause and puff pause interval are related records. Taken together, they tell us indicate that this smoking regimen pauses for 30 seconds every 10 puffs. |
|
| Dataset2 |
|---|
| STUDYID | DOMAIN | SPDEVID | DUSEQ | DUREFID | DUGRPID | DUTESTCD | DUTEST | DUORRES | DUORRESU | DUSTRESC | DUSTRESN | DUSTRESU |
|---|
| 1 | TOB07 | DU | PUFFMASTER3K | 1 | NON-INTENSE METHODREGIMEN |
| PUFFPROF | Puff Profile | SQUARE |
| SQUARE |
|
| | 2 | TOB07 | DU | PUFFMASTER3K | 2 | NON-INTENSE METHODREGIMEN |
| PUFFDUR | Puff Duration | 1.25 | sec | 1.25 | 1.25 | sec | | 3 | TOB07 | DU | PUFFMASTER3K | 3 | NON-INTENSE METHODREGIMEN |
| PUFFINT | Puff Interval | 3 | PUFF/min | 3 | 3 | PUFF/min | | 4 | TOB07 | DU | PUFFMASTER3K | 4 | NON-INTENSE METHODREGIMEN |
| PUFFBLCK | Puff Block | 25 | % | 25 | 25 | % | | 5 | TOB07 | DU | PUFFMASTER3K | 5 | NON-INTENSE METHODREGIMEN |
| NUMPUFF | Total Number of Puffs | 200 | PUFF | 200 | 200 | PUFF | | 6 | TOB07 | DU | PUFFMASTER3K | 6 | NON-INTENSE METHODREGIMEN |
| PUFFVOL | Puff Volume | 10 | mL | 10 | 10 | mL | | 7 | TOB07 | DU | PUFFMASTER3K | 7 | NON-INTENSE METHODREGIMEN |
| PUFFRNG | Puff Range | 100-200 |
| 100-200 |
|
| | 8 | TOB07 | DU | PUFFMASTER3K | 8 | NON-INTENSE METHODREGIMEN | 1 | PUFFPAUS | Puff Pause | 60 | s | 60 | 60 | s | | 9 | TOB07 | DU | PUFFMASTER3K | 9 | NON-INTENSE METHODREGIMEN | 1 | PUFFPINT | Puff Pause Interval | 10 | PUFF | 10 | 10 | PUFF | | 10 | TOB07 | DU | PUFFMASTER3K | 1 | INTENSE METHODREGIMEN |
| PUFFPROF | Puff Profile | SQUARE |
| SQUARE |
|
| | 11 | TOB07 | DU | PUFFMASTER3K | 2 | INTENSE METHODREGIMEN |
| PUFFDUR | Puff Duration | 12.525 | sec | 12.525 1 | 2.525 | sec | | 12 | TOB07 | DU | PUFFMASTER3K | 3 | INTENSE METHODREGIMEN |
| PUFFINT | Puff Interval | 3 | PUFF/min | 3 | 3 | PUFF/min | | 13 | TOB07 | DU | PUFFMASTER3K | 4 | INTENSE METHODREGIMEN |
| PUFFBLCK | Puff Block | 30 | % | 30 | 30 | % | | 14 | TOB07 | DU | PUFFMASTER3K | 5 | INTENSE METHODREGIMEN |
| NUMPUFFPUFFNUM | Total Number of Puffs | 100 | PUFF | 100 | 100 | PUFF | | 15 | TOB07 | DU | PUFFMASTER3K | 6 | INTENSE METHODREGIMEN |
| PUFFVOL | Puff Volume | 1020 | mL | 1020 10 | 20 | mL | | 16 | TOB07 | DU | PUFFMASTER3K | 7 | INTENSE METHODREGIMEN |
| PUFFRNG | Puff Range | 50-150 |
| 50-150 |
|
| | 17 | TOB07 | DU | PUFFMASTER3K | 8 | INTENSE METHODREGIMEN | 2 | PUFFPAUS | Puff Pause | 30 | s | 30 | 30 | s | | 18 | TOB07 | DU | PUFFMASTER3K | 9 | INTENSE METHODREGIMEN | 2 | PUFFPINT | Puff Pause Interval | 10 | PUFF | 10 | 10 | PUFF |
|
|