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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.

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. 

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 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 

Rows 1-17:Show the HPHC testing performed 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. SPDEVID indicates the smoking machine identified in the DI dataset example below. The smoking regimen is shown in PTREFID. The parameters of the smoking regimen are represented in the DU domain (example below) and are matched by using the same value of DUREFID). Note that PTSPEC (Matrix Type) is "SMOKE" for these 3 records (vs "TOBACCO") for all other records in this dataset.
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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pt.xpt

RowSTUDYIDDOMAINSPTOBIDSPDEVIDPTSEQPTREFIDPTCASPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTMETHODPTREPNUMPTTPTPTTPTNUMPTDTC
1TOB07PTCIG01a
8
71-43-2BENZNBenzeneHPHC TESTINGHPHC33µg/cigarette3333µg/cigaretteTOBACCOISO METHOD1Week 012022-09-30
2TOB07PTCIG01a
9
50-32-8BENZOAPBenzo[a]pyreneHPHC TESTINGHPHC6.8ng/cigarette6.86.8ng/cigaretteTOBACCOISO METHOD1Week 012022-09-30
3





















4TOB07PTCIG01aPUFFMASTER3K15Medium Intensity Regimen64091-91-4NNKNicotine-Derived Nitrosamine KetoneHPHC TESTINGHPHC71ng/cigarette7171ng/cigaretteSMOKEISO METHOD1Week 012022-09-30
5TOB07PTCIG01aPUFFMASTER3K16Medium Intensity Regimen16543-55-8NNNN-nitrosonornicotineHPHC TESTINGHPHC85ng/cigarette8585ng/cigaretteSMOKEISO METHOD1Week 012022-09-30
6





















7

STUDYID

DOMAINSPTOBID
PTSEQPTREFIDPTCSREFIDPTTESTCDPTTESTPTCATHPHC vs other constituentsPTORRESUnitPTSTRESCPTSTRESNPTSTRESUPTSPECPTMETHODPTREPNUMPTTPTPTTPTNUMPTDTC
8









PTSCAT
PTORRESU


PTMETHOD

Week 01
9





1954-11-05NICNicotineHPHC TESTING
3mg/mL33mg/mLTL001 v3-1Week 012022-09-30
10









HPHC










11TOB08PTENDS02a
1Batch 10175-07-0ACETALDAcetaldehydeHPHC TESTINGHPHC7.9µg/mL7.97.9µg/mLTL- 201 v4.2-1Week 012022-09-30
12


PUFFMASTER3K

1954-11-05NICNicotineHPHC TESTINGHPHC53.5µg/puff53.553.5µg/puffTL -544 v 3.1Non-intense1Week 012022-09-30
13TOB08PTENDS02aPUFFMASTER3K2Batch 10175-07-0ACETALDAcetaldehydeHPHC TESTINGHPHC34.7ng/puff34.734.7ng/puff
Non-intense1

2022-09-30
14


PUFFMASTER3K



Benzoic AcidHPHC TESTINGOther43.3µg/puff43.343.3µg/puff
Non-intense1

2022-09-30
15


PUFFMASTER3K

1954-11-05NICNicotineHPHC TESTINGHPHC105µg/puff105105µg/puff
Intense1

2022-09-30
16TOB08PTENDS02aPUFFMASTER3K2Batch 10175-07-0ACETALDAcetaldehydeHPHC TESTINGHPHC43.5ng/puff43.543.5ng/puff
Intense1

2022-09-30
17


PUFFMASTER3K



Benzoic AcidHPHC TESTINGOther84.1µg/puff84.184.1µg/puff
Intense1

2022-09-30

Dataset Debug Message

There seem to be multiple domains (PT, <br/>, DOMAIN) present in the dataset.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The identifying characteristics of the smoking machine are represented in the Device Identifiers reference dataset.

di.xpt

di.xpt

RowSTUDYIDDOMAINSPDEVIDDISEQDIPARMCDDIPARMDIVAL
1TOB07DIPUFFMASTER3K1DEVTYPEDevice TypeSmoking Machine
2TOB07DIPUFFMASTER3K2MANUFManufacturerAcme
3TOB07DIPUFFMASTER3K3TRADENAMTrade NamePuffMaster 3000
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Details of the smoking 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 = "Medium Intensity Regimen". 

du.xpt

du.xpt

Row

STUDYIDDOMAINSPDEVIDDUSEQDUREFIDDUGRPIDDUTESTCDDUTESTDUORRESDUORRESUDUSTRESCDUSTRESNDUSTRESU
1

TOB07

DUPUFFMASTER3K1Medium Intensity Regimen
PUFFPROFPuff ProfileSQUARE
SQUARE

2

TOB07

DUPUFFMASTER3K2Medium Intensity Regimen

PUFFDUR

Puff Duration

1.25

sec

1.25

1.25

sec

3

TOB07

DUPUFFMASTER3K3Medium Intensity Regimen

PUFFINT

Puff Interval

3

PUFF/min

3

3

PUFF/min

4

TOB07

DUPUFFMASTER3K4Medium Intensity Regimen

PUFFBLCK

Puff Block

25

%

25

25

%

5

TOB07

DUPUFFMASTER3K5Medium Intensity Regimen
NUMPUFFTotal Number of Puffs

200

PUFF

200

200

PUFF

6

TOB07

DUPUFFMASTER3K6Medium Intensity Regimen
PUFFVOLPuff Volume

10

mL

10

10

mL

7

TOB07

DUPUFFMASTER3K7Medium Intensity Regimen
PUFFRNGPuff Range

100-200


100-200



8

TOB07

DUPUFFMASTER3K8Medium Intensity Regimen1PUFFPAUSPuff Pause

60

s

60

60

s

9TOB07DUPUFFMASTER3K9Medium Intensity Regimen1PUFFPINTPuff Pause Interval

10

PUFF

10

10

PUFF

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