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https://open.canada.ca/data/en/dataset/71394df3-aee8-4117-92cb-a035360972a2/resource/7e6b0457-051e-4620-befc-8e4f50b75345 

John- Maybe I should use PTESTYP  with the code list (RESTYPRS)  SUBSTANCE CONCENTRATION", "PROPORTION", "MASS RATE", "ARBITRARY CONCENTRATION"

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 sposnor. 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.

ACETALD
Dataset wrap
Namept
Rowcaps
Rows 1-1517:

Show

the

HPHC testing performed

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. 
PTMETHOD
Dataset2
RowSTUDYIDDOMAINSPTOBIDSPDEVIDPTSEQPTREFIDPTTESTCDPTTEST
PTTSTDTL
PTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESU
PTTSTCND
PTXFNPTNAM
PTLLOQ
PTSPECPTREPNUMPTDTC
1TOB07PTCIG01aPUFFMASTER3K1
Sample 1
NON-INTENSE REGIMENACTALDAcetaldehyde
QUANTITY
HPHC TESTING
SMOKED PRODUCT
HPHC
1639
522ug/cigarette
1639
522
1639
522ug/cigarette
ISO INTENSE METHODGC-MS
TL001_V5.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
2TOB07PTCIG01aPUFFMASTER3K2
Sample 1ACROL
NON-INTENSE REGIMENACROLEINAcrolein
QUANTITY
HPHC TESTINGHPHC
TESTING
154
43ug/cigarette
154
43
154
43ug/cigarette
ISO INTENSE METHODGC-MS
TL002_V3.6.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
3TOB07PTCIG01aPUFFMASTER3K3
Sample 1ACRLONI
NON-INTENSE REGIMENACRYNTRLAcrylonitrile

QUANTITY

HPHC TESTING

ISO INTENSE METHOD
HPHC TESTINGHPHC7ug/cigarette77ug/cigaretteTL006_V6.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
4TOB07PTCIG01aPUFFMASTER3K4
Sample 1AMNPHEN4
NON-INTENSE REGIMENABP44-Aminobiphenyl
QUANTITY
HPHC TESTINGHPHC
TESTINGISO INTENSE METHODTOBACCO LAB 1
1.2ng/cigarette1.21.2ng/cigaretteTL008_V3.pdfTPT LABCOSMOKE12022-09-30
5TOB07PTCIG01aPUFFMASTER3K5
Sample 1
NON-INTENSE REGIMENAMNPHTH11-Aminonaphthalene

QUANTITY

HPHC TESTING

ISO INTENSE METHOD
HPHC TESTINGHPHC14ng/cigarette1414ng/cigaretteTL003_V1.4.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
6TOB07PTCIG01aPUFFMASTER3K6
Sample 1NH4AmmoniaQUANTITYHPHC TESTING29.2ug/cigarette29.229.2ug/cigaretteISO INTENSE METHODIC
NON-INTENSE REGIMENAMNPHTH22-AminonaphthaleneHPHC TESTINGHPHC8ng/cigarette88ng/cigaretteTL003_V1.4.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
7TOB07PTCIG01aPUFFMASTER3K7
Sample 1BENZBenzene

QUANTITY

HPHC TESTING

ISO INTENSE METHOD
NON-INTENSE REGIMENAMMONIAAmmoniaHPHC TESTINGHPHC9ug/cigarette99ug/cigaretteTL020_V4.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
8TOB07PTCIG01aPUFFMASTER3K8
Sample 1BENZAPBenzo[a]pyreneQUANTITYHPHC TESTING
NON-INTENSE REGIMENBENZENEBenzeneHPHC TESTINGHPHC33
30.5
ug/cigarette
30.5
3333
30.5
ug/cigarette
ISO INTENSE METHOD
TL017_V1.1.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
9TOB07PTCIG01aPUFFMASTER3K9
Sample 1COCarbon monoxide

QUANTITY

HPHC TESTING

28.2ug/cigarette28.228.2ug/cigaretteISO INTENSE METHOD
NON-INTENSE REGIMENBZAPYRBenzo[a]pyreneHPHC TESTINGHPHC6.8ng/cigarette6.86.8ng/cigaretteTL017_V1.1.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
10TOB07PTCIG01aPUFFMASTER3K10
Sample 1CROTALDCrotonaldehydeQUANTITYHPHC TESTING0.010.010.01ISO INTENSE METHOD
NON-INTENSE REGIMENCMONOXCarbon MonoxideHPHC TESTINGHPHC10.1mg/cigarette10.110.1mg/cigaretteTL019_V3.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
11TOB07PTCIG01aPUFFMASTER3K11
Sample 1FORMALDFormaldehyde

QUANTITY

HPHC TESTING

NON-INTENSE REGIMENCROTNALDCrotonaldehydeHPHC TESTINGHPHC11
83.2
ug/cigarette
83.2
1111
83.2
ug/cigarette
ISO INTENSE METHOD
TL001_V5.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
12TOB07PTCIG01aPUFFMASTER3K12
Sample 1ISOPRNIsopreneQUANTITYHPHC TESTINGISO INTENSE METHOD
NON-INTENSE REGIMENFORMALDFormaldehydeHPHC TESTINGHPHC27ug/cigarette2727ug/cigaretteTL001_V5.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
13TOB07PTCIG01aPUFFMASTER3K13
Sample 1NICNicotine

QUANITY

HPHC TESTING

NON-INTENSE REGIMENISOPRENEIsopreneHPHC TESTINGHPHC320ug/cigarette320320
1.71
ug/cigarette
1.711.71ug/cigaretteISO INTENSE METHODLC-MS/MSTOBACCO LAB 1
TL041_V1.pdfTPT LABCOSMOKE12022-09-30
14TOB07PTCIG01aPUFFMASTER3K14NON-INTENSE REGIMENNICOTINENicotineHPHC TESTINGHPHC0.721mg/cigarette0.7210.721mg/cigaretteTL007_V2.1.pdfTPT LABCOSMOKE12022-09-30
14
15TOB07PTCIG01aPUFFMASTER3K
14
15NON-INTENSE REGIMEN
Sample 1
NNKNicotine-
derived
Derived Nitrosamine Ketone
QUANTITY
HPHC TESTINGHPHC
TESTINGISO INTENSE METHODLC-MS/MS
71ng/cigarette7171ng/cigaretteTL026_V12.2.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
15
16TOB07PTCIG01a
15
PUFFMASTER3K16NON-INTENSE REGIMEN
Sample 1
NNNN-
nitrosonornicotine

QUANTITY

HPHC TESTING

284
NitrosonornicotineHPHC TESTINGHPHC85ng/cigarette8585ng/cigaretteTL026_V12.2.pdfTPT LABCOSMOKE12022-09-30
17TOB07PTCIG01aPUFFMASTER3K17NON-INTENSE REGIMENTOLUENETolueneHPHC TESTINGHPHC53ug/cigarette
284
53
284
53ug/cigarette
ISO INTENSE METHODLC-MS/MS
TL011_V3.3.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
16
18TOB07PTCIG01a

16

Sample 1ACETALD

Acetaldehyde

PUFFMASTER3K18INTENSE REGIMENACTALDAcetaldehydeHPHC TESTINGHPHC1552ug/cigarette15521552ug/cigaretteTL009_V4.3.pdfTPT LABCOSMOKE12022-09-30
19TOB07PTCIG01a
19
AMMONIAAmmonia
QUANTITY
HPHC TESTING
1569
HPHC956ug/
cigarette
g
1569
956
1569
956ug/cigarette
CANADIAN INTENSE METHOD
TL016_V1.2.pdfTPT LABCOTOBACCO FILLER
TOBACCO LAB 1
12022-09-30

The Trial Lookup table can be used to provide additional details on any test conditions or methods 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 testingsmoking regimen.   

Dataset wrap
titlelb.xpt
NameTLdi
Big
Dataset2
RowSTUDYIDDOMAIN
RDOMAIN
SPDEVIDDISEQ
TLVAR1
DIPARMCD
TLVRVAL1
DIPARM
TLSEQ
DIVAL
TLPARMCD
1
TLPARM
TOB07
TLVAL
DI
TLVALU
PUFFMASTER3K1DEVTYPEDevice Type

TOB07

TLPTPTSTCONDISO INTENSE METHOD1ISOSTNUMISO Standard NumberISO 3308
2

TOB07

TLPTPTSTCONDISO INTENSE METHOD2PUFFVOLPuff Volume34mg
3

TOB07

TLPTPTSTCONDISO INTENSE METHOD3TEMP Temperature 
4

TOB07

TLPTPTSTCONDISO INTENSE METHOD4PUFFVOLPuff Volume35mg
5

TOB07

TLPTPTSTCONDCANADIAN INTENSE METHOD1PUFFDURPuff DurationPT10M6

TOB07

TLPTPTSTCONDCANADIAN INTENSE METHOD2SMOKMACSmoking Machine
Smoking Machine
2TOB07DIPUFFMASTER3K2MANUFManufacturerAcme
3TOB07DIPUFFMASTER3K3TRADENAMTrade NamePuffMaster 3000

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.

Dataset wrap
Namedu
Rowcaps
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.
Dataset2

Row

STUDYIDDOMAINSPDEVIDDUSEQDUREFIDDUGRPIDDUTESTCDDUTESTDUORRESDUORRESUDUSTRESCDUSTRESNDUSTRESU
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

PUFFNUM

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

2.25

sec

2.25

2.25

sec

12

TOB07

DUPUFFMASTER3K3INTENSE REGIMEN

PUFFINT

Puff Interval

3

PUFF/min

3

3

PUFF/min

13

TOB07

DUPUFFMASTER3K4INTENSE REGIMEN

PUFFBLCK

Puff Block

30

%

30

30

%

14

TOB07

DUPUFFMASTER3K5INTENSE REGIMEN
PUFFNUMNumber of Puffs

100

PUFF

100

100

PUFF

15

TOB07

DUPUFFMASTER3K6INTENSE REGIMEN
PUFFVOLPuff Volume

20

mL

20

20

mL

16

TOB07

DUPUFFMASTER3K7INTENSE REGIMEN
PUFFRNGPuff Range

50-150


50-150



17

TOB07

DUPUFFMASTER3K8INTENSE REGIMEN2PUFFPAUSPuff Pause

30

s

30

30

s

18TOB07DUPUFFMASTER3K9INTENSE REGIMEN2PUFFPINTPuff Pause Interval

10

PUFF

10

10

PUFF