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NOTE: THIS SECTION MAY CHANGE . DEVICE DOMAIN MAY BE USED TO REPRESENT THE SMOKING MACHINE PARAMETERS Fix MATRIX variable |
https://open.canada.ca/data/en/dataset/71394df3-aee8-4117-92cb-a035360972a2/resource/7e6b0457-051e-4620-befc-8e4f50b75345
The following example illustrates how to represent results from HPHC testing of a tobacco product under study using the Product Testing (PT) domain. This testing is conduct on samples of the product of interest, and if applicable samples of comparison products. Each product tested would have it's own unique sponsor-defined value for SPTOBID to identify the product. 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 Section 3.1.4, Stability Studies, for more information and examples illustrating how to represent those data.
This example only shows test results for each constituent for one 1 replicate of 1 sample of one 1 product that was tested . The sampling plan (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. In reality, sponsors would applicant or by regulatory requirement. Applicants would likely have multiple product samples tested in multiple replicates, and those would be distinguished in the dataset . These sample identification information may be represented in PTREFID, and/ or PTSPID. In this example, SPTOBID indicated the product identification, and each sample of that product was numbered as Sample 1 thru Sample n. Many sponsor may use more specific codes to identify the source of product sample. 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 1-1517: | the on one sample of the product with SPTOBID CIG01a. The test condition are represented in PTTSTCND. 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. | Row 16: | Shows the HPHC testing performed on one sample for one ingredient using the CANDIAN INTENSE test conditions. |
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| Row | STUDYID | DOMAIN | SPTOBID | SPDEVID | PTSEQ | PTREFID | 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 |
Sample 1 | ACETALD| NON-INTENSE REGIMEN | ACTALD | Acetaldehyde | HPHC TESTING | HPHC |
163916391639SMOKE | ISO INTENSE METHOD | 1 | Week 0| TL001_V5.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 2 | TOB07 | PT | CIG01a | PUFFMASTER3K | 2 |
Sample 1 | ACROL| NON-INTENSE REGIMEN | ACROLEIN | Acrolein | HPHC TESTING | HPHC |
154154154ISO INTENSE METHOD| TL002_V3.6.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 3 | TOB07 | PT | CIG01a | PUFFMASTER3K | 3 |
Sample 1 | ACRLONI| NON-INTENSE REGIMEN | ACRYNTRL | Acrylonitrile | HPHC TESTING | HPHC |
| 7 | ug/cigarette | 7 | 7 | ug/cigarette | TL006_V6.pdf | TPT LABCO | SMOKE |
ISO INTENSE METHOD | 1 | 2022-09-30 | | 4 | TOB07 | PT | CIG01a | PUFFMASTER3K | 4 |
Sample 1 | AMNPHEN4| NON-INTENSE REGIMEN | ABP4 | 4-Aminobiphenyl | HPHC TESTING | HPHC |
| 1.2 | ng/cigarette | 1.2 | 1.2 | ng/cigarette | TL008_V3.pdf | TPT LABCO | SMOKE |
ISO INTENSE METHOD | 1 | 2022-09-30 | | 5 | TOB07 | PT | CIG01a | PUFFMASTER3K | 5 |
Sample 1| NON-INTENSE REGIMEN | AMNPHTH1 | 1-Aminonaphthalene | HPHC TESTING | HPHC |
ISO INTENSE METHOD| 14 | ng/cigarette | 14 | 14 | ng/cigarette | TL003_V1.4.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 6 | TOB07 | PT | CIG01a | PUFFMASTER3K | 6 |
Sample 1 | NH4 | | NON-INTENSE REGIMEN | AMNPHTH2 | 2-Aminonaphthalene |
Ammonia29.2ug29.2 | 29.2 | ug/cigarette | | 8 | 8 | ng/cigarette | TL003_V1.4.pdf | TPT LABCO | SMOKE |
ISO INTENSE METHOD | 1 | 2022-09-30 | | 7 | TOB07 | PT | CIG01a | PUFFMASTER3K | 7 |
Sample 1 | BENZ | | NON-INTENSE REGIMEN | AMMONIA | Ammonia |
Benzene | 9 | ug/cigarette | 9 | 9 | ug/cigarette | TL020_V4.pdf | TPT LABCO | SMOKE |
ISO INTENSE METHOD | 1 | 2022-09-30 | | 8 | TOB07 | PT | CIG01a | PUFFMASTER3K | 8 |
Sample 1 | BENZAP | | NON-INTENSE REGIMEN | BENZENE | Benzene |
Benzo[a]pyrene30.530.5 | 30.5ISO INTENSE METHOD| TL017_V1.1.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 9 | TOB07 | PT | CIG01a | PUFFMASTER3K | 9 |
Sample 1 | CO | | NON-INTENSE REGIMEN | BZAPYR | Benzo[a]pyrene |
Carbon monoxide282ug282282ug | TL017_V1.1.pdf | TPT LABCO | SMOKE |
ISO INTENSE METHOD | 1 | 2022-09-30 | | 10 | TOB07 | PT | CIG01a | PUFFMASTER3K | 10 |
Sample 1 | CROTALD | | NON-INTENSE REGIMEN | CMONOX | Carbon Monoxide |
Crotonaldehyde0.01 | 0.01 | 0.01 | | 10.1 | mg/cigarette | 10.1 | 10.1 | mg/cigarette | TL019_V3.pdf | TPT LABCO | SMOKE |
ISO INTENSE METHOD | 1 | 2022-09-30 | | 11 | TOB07 | PT | CIG01a | PUFFMASTER3K | 11 |
Sample 1 | FORMALD | | NON-INTENSE REGIMEN | CROTNALD | Crotonaldehyde |
Formaldehyde83.283.2 | 83.2 | TL001_V5.pdf | TPT LABCO | SMOKE |
ISO INTENSE METHOD | 1 | 2022-09-30 | | 12 | TOB07 | PT | CIG01a | PUFFMASTER3K | 12 |
Sample 1 | ISOPRN | | NON-INTENSE REGIMEN | FORMALD | Formaldehyde |
Isoprene | 27 | ug/cigarette | 27 | 27 | ug/cigarette | TL001_V5.pdf | TPT LABCO | SMOKE |
ISO INTENSE METHOD | 1 | 2022-09-30 | | 13 | TOB07 | PT | CIG01a |
13 | Sample 1 | NIC| PUFFMASTER3K | 13 | NON-INTENSE REGIMEN | 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 | NICOTINE | Nicotine | HPHC TESTING | HPHC |
171ug171171ug | TL007_V2.1.pdf | TPT LABCO | SMOKE |
ISO INTENSE METHOD14| 15 | TOB07 | PT | CIG01a | PUFFMASTER3K |
14 | Sample 1derived | Derived Nitrosamine Ketone | HPHC TESTING | HPHC |
| 71 | ng/cigarette | 71 | 71 | ng/cigarette | TL026_V12.2.pdf | TPT LABCO | SMOKE |
ISO INTENSE METHOD15| 16 | TOB07 | PT | CIG01a | PUFFMASTER3K |
15 | Sample 1-nitrosonornicotine| -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 | TOLUENE | Toluene | HPHC TESTING | HPHC |
284284284ISO INTENSE METHOD| TL011_V3.3.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 |
16| 18 | TOB07 | PT | CIG01a | PUFFMASTER3K |
16Sample 1ACETALD| ACTALD | Acetaldehyde | HPHC TESTING | HPHC |
1569 | 1552 | ug/cigarette | 1552 | 1552 | ug/cigarette |
1569 | | TL009_V4.3.pdf | TPT LABCO | SMOKE | 1 | 2022-09-30 | | 19 | TOB07 | PT | CIG01a |
| 19 |
| AMMONIA | Ammonia | HPHC TESTING | HPHC | 956 | ug/g | 956 | 956 |
1569CANADIAN INTENSE METHOD | TL016_V1.2.pdf | TPT LABCO | TOBACCO FILLER | 1 | 2022-09-30 |
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The Environmental Storage Conditions (ES) dataset can be used to provide additional details on any test conditions or methods used to perform the testing. 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 by matching values of PTREFID/DUREFID.
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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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| STOCONID | ESSEQ | ESPARMCD | ESPARM | ESVAL | ESVALU | SPDEVID | DUSEQ | DUREFID | DUGRPID | DUTESTCD | DUTEST | DUORRES | DUORRESU | DUSTRESC | DUSTRESN | DUSTRESU |
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| 1 | TOB07 | DU |
ESCondition 1ISOSTNUM | ISO Standard Number | ISO 3308| Puff Profile | SQUARE |
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| | 2 | TOB07 |
ESCondition 1| PUFFMASTER3K | 2 | NON-INTENSE REGIMEN |
PUFFVOLPT2SES | Condition 1 | 3 | PUFFVOL | Puff Volume | 35 | mg | 4 | TOB07 | ES | Condition 2 | 1 | PUFFDUR | Puff Duration | PT2S | 5 | TOB07 | ES | Condition 2 | 2 | SMOKMAC | Smoking Machine | Big| DU | PUFFMASTER3K | 3 | NON-INTENSE REGIMEN |
| PUFFINT | Puff Interval | 3 | PUFF/min | 3 | 3 | PUFF/min | | 4 | TOB07 | DU | PUFFMASTER3K | 4 | NON-INTENSE REGIMEN |
| PUFFBLCK | Puff Block | 25 | % | 25 | 25 | % | | 5 | TOB07 | DU | PUFFMASTER3K | 5 | NON-INTENSE REGIMEN |
| | Number of Puffs | 200 | PUFF | 200 | 200 | PUFF | | 6 | TOB07 | DU | PUFFMASTER3K | 6 | NON-INTENSE REGIMEN |
| PUFFVOL | Puff Volume | 10 | mL | 10 | 10 | mL | | 7 | TOB07 | DU | PUFFMASTER3K | 7 | NON-INTENSE REGIMEN |
| PUFFRNG | Puff Range | 100-200 |
| 100-200 |
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| | 8 | TOB07 | DU | PUFFMASTER3K | 8 | NON-INTENSE REGIMEN | 1 | PUFFPAUS | Puff Pause | 60 | s | 60 | 60 | s | | 9 | TOB07 | DU | PUFFMASTER3K | 9 | 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 | 2 | PUFFPINT | Puff Pause Interval | 10 | PUFF | 10 | 10 | PUFF |
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