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Tobacco product HPHC testing results are represented in the PT domain. This example 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 sponsor-defined value for SPTOBID to identify the product. 

Jon - since we started with using PTREFID for the Smoking Regimen in the Cig. example, The batch number could go in --SPID. It seems like Smoking Regimen is a method for testing and I am not sure --REFID is the right place for the "Smoking Regimen".

The following references were used as guidance for the example below:

  1. Aerosol data used data from: https://www.mdpi.com/2297-8739/8/10/168/htm was from a 3% nicotine solution.

       2. Data for acetaldehyde in solution from Chemical evaluation of electronic cigarettes | Tobacco Control (bmj.com), calculation below

Rows 1-2:Show 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.
Rows 3-5:Show the HPHC testing performed for three constituents using the NON-INTENSE SMOKING REGIME for BATCH 1 and Replicate 1.
Rows 6-7:Show the HPHC testing performed for three constituents using the INTENSE SMOKING REGIME for BATCH 1 and Replicate 1.

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDSPDEVIDPTSEQPTREFIDPTSPIDPTCASPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTMETHODPTREPNUMPTDTC
1TOB08PTENDS02a
1Batch 101??? -put batch here?75-07-0ACETALDAcetaldehydeHPHC TESTINGHPHC7.9µg/mL7.97.9µg/mLE-LIQUID
12022-09-30
2TOB08PTENDS02aPUFFMASTER3K2Batch 101
1954-11-05NICNicotineHPHC TESTINGHPHC53.5µg/puff53.553.5µg/puffAEROSOLNon-intense12022-09-30
3TOB08PTENDS02aPUFFMASTER3K3Batch 101
75-07-0ACETALDAcetaldehydeHPHC TESTINGHPHC34.7ng/puff34.734.7ng/puffAEROSOLNon-intense12022-09-30
4TOB08PTENDS02aPUFFMASTER3K4Batch 101
65-85-0
Benzoic AcidHPHC TESTINGOther43.3µg/puff43.343.3µg/puffAEROSOLNon-intense12022-09-30
5TOB08PTENDS02aPUFFMASTER3K5Batch 101
1954-11-05NICNicotineHPHC TESTINGHPHC105µg/puff105105µg/puffAEROSOLIntense22022-09-30
6TOB08PTENDS02aPUFFMASTER3K6Batch 101
75-07-0ACETALDAcetaldehydeHPHC TESTINGHPHC43.5ng/puff43.543.5ng/puffAEROSOLIntense22022-09-30
7TOB08PTENDS02aPUFFMASTER3K7Batch 101
65-85-0
Benzoic AcidHPHC TESTINGOther84.1µg/puff84.184.1µg/puffAEROSOLIntense22022-09-30
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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 = "Non-intense Regimen". 

du.xpt

du.xpt

RowSTUDYIDDOMAINSPDEVIDDUSEQDUREFIDDUGRPIDDUTESTCDDUTESTDUORRESDUORRESUDUSTRESCDUSTRESNDUSTRESU
1

TOB07

DUPUFFMASTER3K1Non-intense Regimen
PUFFPROFPuff ProfileSQUARE
SQUARE

2

TOB07

DUPUFFMASTER3K2Non-intense Regimen

PUFFDUR

Puff Duration

1.25

sec

1.25

1.25

sec

3

TOB07

DUPUFFMASTER3K3Non-intense Regimen

PUFFINT

Puff Interval

3

PUFF/min

3

3

PUFF/min

4

TOB07

DUPUFFMASTER3K4Non-intense Regimen

PUFFBLCK

Puff Block

25

%

25

25

%

5

TOB07

DUPUFFMASTER3K5Non-intense Regimen
NUMPUFFTotal Number of Puffs

200

PUFF

200

200

PUFF

6

TOB07

DUPUFFMASTER3K6Non-intense Regimen
PUFFVOLPuff Volume

10

mL

10

10

mL

7

TOB07

DUPUFFMASTER3K7Non-intense Regimen
PUFFRNGPuff Range

100-200


100-200



8

TOB07

DUPUFFMASTER3K8Non-intense Regimen1PUFFPAUSPuff Pause

60

s

60

60

s

9TOB07DUPUFFMASTER3K9Non-intense Regimen1PUFFPINTPuff Pause Interval

10

PUFF

10

10

PUFF

10

TOB07

DUPUFFMASTER3K1Intense Regimen
PUFFPROFPuff ProfileSQUARE
SQUARE

11

TOB07

DUPUFFMASTER3K2Intense Regimen

PUFFDUR

Puff Duration

1.25

sec

1.25

1.25

sec

12

TOB07

DUPUFFMASTER3K3Intense Regimen

PUFFINT

Puff Interval

3

PUFF/min

3

3

PUFF/min

13

TOB07

DUPUFFMASTER3K4Intense Regimen

PUFFBLCK

Puff Block

25

%

25

25

%

14

TOB07

DUPUFFMASTER3K5Intense Regimen
NUMPUFFTotal Number of Puffs

200

PUFF

200

200

PUFF

15

TOB07

DUPUFFMASTER3K6Intense Regimen
PUFFVOLPuff Volume

10

mL

10

10

mL

16

TOB07

DUPUFFMASTER3K7Intense Regimen
PUFFRNGPuff Range

100-200


100-200



17

TOB07

DUPUFFMASTER3K8Intense Regimen1PUFFPAUSPuff Pause

10

s

10

10

s

18TOB07DUPUFFMASTER3K9Intense Regimen1PUFFPINTPuff Pause Interval

20

PUFF

20

20

PUFF

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