HPHC testing
Aerosol data used data from: https://www.mdpi.com/2297-8739/8/10/168/htm was from a 3% nicotine solution.
Data for acetaldehyde in solution from Chemical evaluation of electronic cigarettes | Tobacco Control (bmj.com), calculation below
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 1-2: | Show Shows the HPHC testing performed for two constituents on Batch 1, Replication 1 for the liquid matrix. The CAS number of the constituent is provided in PTCAS.acetaldehyde from a sample of e-Liquid (as indicated by PTSPEC=E-LIQUID). | | Rows 2-4: | Show | Rows 3-5: | Shows the HPHC testing performed for three constituents 3 analytes from aerosol produced using the NON-INTENSE SMOKING REGIME for BATCH 1 and Replicate 1.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 5Rows 6-7: | Shows Show the HPHC testing performed for three constituents using the INTENSE SMOKING REGIME for BATCH 1 and Replicate 13 analytes using the intense regimen on the same smoking machine (PTREFID=INTENSE REGIMEN). |
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| Row | STUDYID | DOMAIN | SPTOBID | SPDEVID | PTSEQ | PTREFID |
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PTSPID | PTCAS | PTTESTCD | PTTEST | PTCAT | PTSCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC |
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PTMETHOD | PTREPNUM | PTDTC |
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| 1 | TOB08 | PT | ENDS02a |
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Batch 101 | since we started with using PTREFID for the Smoking Regimen in the Cig. example, The batch number could go here. It seems like Smoking Regimen is a method though. | 75-07-0 | ACETALD |
| ACTALD | Acetaldehyde | HPHC TESTING | HPHC | 7.9 | µg/mL | 7.9 | 7.9 | µg/mL | E-LIQUID | 1 | 2022-09-30 | | 2 | TOB08 | PT | ENDS02a | PUFFMASTER3K | 2 |
Batch 101 | 1954-11-05 | NIC| NON-INTENSE REGIMEN | NICOTINE | Nicotine | HPHC TESTING | HPHC | 53.5 | µg/puff | 53.5 | 53.5 | µg/puff | AEROSOL |
Non-intense | 1 | 2022-09-30 | | 3 | TOB08 | PT | ENDS02a | PUFFMASTER3K | 3 |
Batch 101 | 75-07-0 | | NON-INTENSE REGIMEN | ACTALD |
ACETALD | Acetaldehyde | HPHC TESTING | HPHC | 34.7 | ng/puff | 34.7 | 34.7 | ng/puff | AEROSOL |
Non-intense | 1 | 2022-09-30 | | 4 | TOB08 | PT | ENDS02a | PUFFMASTER3K | 4 |
Batch 101| NON-INTENSE REGIMEN | BNZOICAC | Benzoic Acid | HPHC TESTING | Other | 43.3 | µg/puff | 43.3 | 43.3 | µg/puff | AEROSOL |
Non-intense | 1 | 2022-09-30 | | 5 | TOB08 | PT | ENDS02a | PUFFMASTER3K | 5 |
Batch 101 | 1954-11-05 | NIC | Nicotine | HPHC TESTING | HPHC | 105 | µg/puff | 105 | 105 | µg/puff | AEROSOL |
Intense | 2 | 2022-09-30 | | 6 | TOB08 | PT | ENDS02a | PUFFMASTER3K | 6 |
Batch 101 | 75-07-0 | ACETALD | | INTENSE REGIMEN | ACTALD | Acetaldehyde | HPHC TESTING | HPHC | 43.5 | ng/puff | 43.5 | 43.5 | ng/puff | AEROSOL |
Intense | 2 | 2022-09-30 | | 7 | TOB08 | PT | ENDS02a | PUFFMASTER3K | 7 |
Batch 101| 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 = "Non-intense 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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| Dataset2 |
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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 | NonNON-intense RegimenINTENSE REGIMEN |
| PUFFPROF | Puff Profile | SQUARE |
| SQUARE |
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| | 2 | TOB07 | DU | PUFFMASTER3K | 2 | NonNON-intense RegimenINTENSE REGIMEN |
| PUFFDUR | Puff Duration | 1.25 | sec | 1.25 | 1.25 | sec | | 3 | TOB07 | DU | PUFFMASTER3K | 3 | NonNON-intense RegimenINTENSE REGIMEN |
| PUFFINT | Puff Interval | 37 | PUFF/min | 37 3 | 7 | PUFF/min | | 4 | TOB07 | DU | PUFFMASTER3K | 4 | NonNON-intense RegimenINTENSE REGIMEN |
| PUFFBLCK | Puff Block | 25 | % | 25 | 25 | % | | 5 | TOB07 | DU | PUFFMASTER3K | 5 | NonNON-intense RegimenINTENSE REGIMEN |
| NUMPUFF | Total Number of Puffs | 200 | PUFF | 200 | 200 | PUFF | | 6 | TOB07 | DU | PUFFMASTER3K | 6 | NonNON-intense RegimenINTENSE REGIMEN |
| PUFFVOL | Puff Volume | 10 | mL | 10 | 10 | mL | | 7 | TOB07 | DU | PUFFMASTER3K | 7 | NonNON-intense RegimenINTENSE REGIMEN |
| PUFFRNG | Puff Range | 100-200 |
| 100-200 |
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| | 8 | TOB07 | DU | PUFFMASTER3K | 8 | NonNON-intense RegimenINTENSE REGIMEN | 1 | PUFFPAUS | Puff Pause | 60 | s | 60 | 60 | s | | 9 | TOB07 | DU | PUFFMASTER3K | 9 | NonNON-intense RegimenINTENSE REGIMEN | 1 | PUFFPINT | Puff Pause Interval | 10 | PUFF | 10 | 10 | PUFF | | 10 | TOB07 | DU | PUFFMASTER3K | 1Intense | RegimenINTENSE REGIMEN |
| PUFFPROF | Puff Profile | SQUARE |
| SQUARE |
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| | 11 | TOB07 | DU | PUFFMASTER3K | 2Intense | RegimenINTENSE REGIMEN |
| PUFFDUR | Puff Duration | 13.25 | sec | 13.25 1 | 3.25 | sec | | 12 | TOB07 | DU | PUFFMASTER3K | 3Intense | RegimenINTENSE REGIMEN |
| PUFFINT | Puff Interval | 310 | PUFF/min | 310 3 | 10 | PUFF/min | | 13 | TOB07 | DU | PUFFMASTER3K | 4Intense | RegimenINTENSE REGIMEN |
| PUFFBLCK | Puff Block | 25 | % | 25 | 25 | % | | 14 | TOB07 | DU | PUFFMASTER3K | 5Intense | RegimenINTENSE REGIMEN |
| NUMPUFFPUFFNUM | Total Number of Puffs | 200300 | PUFF | 200300 200 | 300 | PUFF | | 15 | TOB07 | DU | PUFFMASTER3K | 6Intense | RegimenINTENSE REGIMEN |
| PUFFVOL | Puff Volume | 1025 | mL | 1025 10 | 25 | mL | | 16 | TOB07 | DU | PUFFMASTER3K | 7Intense | RegimenINTENSE REGIMEN |
| PUFFRNG | Puff Range | 100-200400 |
| 100-200400 |
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| | 17 | TOB07 | DU | PUFFMASTER3K | 8Intense | RegimenINTENSE REGIMEN | 12 | PUFFPAUS | Puff Pause | 10 | s | 10 | 10 | s | | 18 | TOB07 | DU | PUFFMASTER3K | 9Intense | RegimenINTENSE REGIMEN | 12 | PUFFPINT | Puff Pause Interval | 2030 | PUFF | 2030 20 | 30 | PUFF |
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