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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.

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
RowSTUDYIDDOMAINSPTOBIDSPDEVIDPTSEQPTREFIDPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESU
PTMATRIXPTTSTCND
PTXFNPTNAM
PTLLOQ
PTSPECPTREPNUMPTDTC
1TOB07PTCIG01aPUFFMASTER3K1
Sample 1
NON-INTENSE REGIMENACTALDAcetaldehydeHPHC TESTING
1639
HPHC522ug/cigarette
1639
522
1639
522ug/cigarette
SMOKEISO INTENSE METHODGC-MSTOBACCO LAB 11
TL001_V5.pdfTPT LABCOSMOKE12022-09-30
2TOB07PTCIG01aPUFFMASTER3K2
Sample 1ACROL
NON-INTENSE REGIMENACROLEINAcroleinHPHC TESTINGHPHC
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 REGIMENACRYNTRLAcrylonitrileHPHC TESTING
ISO INTENSE METHOD
HPHC7ug/cigarette77ug/cigaretteTL006_V6.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
4TOB07PTCIG01aPUFFMASTER3K4
Sample 1AMNPHEN4
NON-INTENSE REGIMENABP44-AminobiphenylHPHC TESTING
ISO INTENSE METHODTOBACCO LAB 11
HPHC1.2ng/cigarette1.21.2ng/cigaretteTL008_V3.pdfTPT LABCOSMOKE12022-09-30
5TOB07PTCIG01aPUFFMASTER3K5
Sample 1
NON-INTENSE REGIMENAMNPHTH11-AminonaphthaleneHPHC TESTING
ISO INTENSE METHOD
HPHC14ng/cigarette1414ng/cigaretteTL003_V1.4.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
6TOB07PTCIG01aPUFFMASTER3K6
Sample 1NH4
NON-INTENSE REGIMENAMNPHTH22-Aminonaphthalene
Ammonia
HPHC TESTINGHPHC
29.2
8
ug
ng/cigarette
29.229.2
88ng
ug
/cigarette
ISO INTENSE METHODIC
TL003_V1.4.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
7TOB07PTCIG01aPUFFMASTER3K7
Sample 1BENZ
NON-INTENSE REGIMENAMMONIAAmmonia
Benzene
HPHC TESTING
ISO INTENSE METHOD
HPHC9ug/cigarette99ug/cigaretteTL020_V4.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
8TOB07PTCIG01aPUFFMASTER3K8
Sample 1BENZAP
NON-INTENSE REGIMENBENZENEBenzene
Benzo[a]pyrene
HPHC TESTINGHPHC
30.5
33ug/cigarette
30.5
3333
30.5
ug/cigarette
ISO INTENSE METHOD
TL017_V1.1.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
9TOB07PTCIG01aPUFFMASTER3K9
Sample 1CO
NON-INTENSE REGIMENBZAPYRBenzo[a]pyrene
Carbon monoxide
HPHC TESTINGHPHC
28
6.
2
8
ug
ng/cigarette
28
6.
2
8
28
6.
2
8
ug
ng/cigarette
ISO INTENSE METHOD
TL017_V1.1.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
10TOB07PTCIG01aPUFFMASTER3K10
Sample 1CROTALD
NON-INTENSE REGIMENCMONOXCarbon Monoxide
Crotonaldehyde
HPHC TESTING
0.010.010.01ISO INTENSE METHOD
HPHC10.1mg/cigarette10.110.1mg/cigaretteTL019_V3.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
11TOB07PTCIG01aPUFFMASTER3K11
Sample 1FORMALD
NON-INTENSE REGIMENCROTNALDCrotonaldehyde
Formaldehyde
HPHC TESTING
83.2
HPHC11ug/cigarette
83.2
1111
83.2
ug/cigarette
ISO INTENSE METHOD
TL001_V5.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
12TOB07PTCIG01aPUFFMASTER3K12
Sample 1ISOPRNIsopreneHPHC TESTINGISO INTENSE METHOD
NON-INTENSE REGIMENFORMALDFormaldehydeHPHC TESTINGHPHC27ug/cigarette2727ug/cigaretteTL001_V5.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
13TOB07PTCIG01aPUFFMASTER3K13
Sample 1NIC
NON-INTENSE REGIMENISOPRENEIsoprene
Nicotine
HPHC TESTING
1.71
HPHC320ug/cigarette320320ug/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 KetoneHPHC TESTING
ISO INTENSE METHODLC-MS/MS
HPHC71ng/cigarette7171ng/cigaretteTL026_V12.2.pdfTPT LABCOSMOKE
TOBACCO LAB 1
12022-09-30
15
16TOB07PTCIG01aPUFFMASTER3K
15
16NON-INTENSE REGIMEN
Sample 1
NNNN
-nitrosonornicotine
-NitrosonornicotineHPHC TESTINGHPHC85ng/cigarette8585ng/cigaretteTL026_V12.2.pdfTPT LABCOSMOKE12022-09-30
17TOB07PTCIG01aPUFFMASTER3K17NON-INTENSE REGIMENTOLUENETolueneHPHC TESTING
284
HPHC53ug/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 1
PUFFMASTER3K18INTENSE REGIMENACTALD
ACETALD
AcetaldehydeHPHC TESTING
1569
HPHC1552ug/cigarette15521552ug/cigarette
1569
TL009_V4.3.pdfTPT LABCOSMOKE12022-09-30
19TOB07PTCIG01a
19
AMMONIAAmmoniaHPHC TESTINGHPHC956ug/g956956
1569
ug/cigarette
CANADIAN INTENSE METHOD
TL016_V1.2.pdfTPT LABCOTOBACCO FILLER
TOBACCO LAB 1
12022-09-30

The Test Conditions dataset 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
NameTCdi
Big
Dataset2
RowSTUDYIDDOMAIN
RDOMAIN
SPDEVIDDISEQ
TCVAR1
DIPARMCD
TCVRVAL1
DIPARM
TCSEQ
DIVAL
TCPARMCD
1
TCPARM
TOB07
TCVAL
DI
TCVALU
PUFFMASTER3K1DEVTYPEDevice TypeSmoking Machine
2TOB07
TCPTPTSTCNDISO INTENSE METHOD1ISOSTNUMISO Standard NumberISO 33082

TOB07

TCPTPTSTCNDISO INTENSE METHOD2PUFFVOLPuff DurationPT2S
3

TOB07

TCPTPTSTCNDISO INTENSE METHOD3PUFFVOLPuff Volume35mg
4

TOB07

TCPTPTSTCNDCANADIAN INTENSE METHOD1PUFFDURPuff DurationPT2S5

TOB07

TCPTPTSTCNDCANADIAN INTENSE METHOD2SMOKMACSmoking Machine
DIPUFFMASTER3K2MANUFManufacturerAcme
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