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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 the Section 3.1.4, Stability Studies section, for more information and examples on handling illustrating how to represent those data.

This example only shows test results for each constituent for one 1 replicate of one 1 sample of one 1 product that was tested (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 applicant or by regulatory requirement.  Sponsors Applicants would likely have multiple product samples tested in multiple replicates, and those would be distinguished in the dataset 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.

Dataset wrap
Namept
Rowcaps
Rows 1-17:

Show HPHC testing performed 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 (

ISO Non

non-intense regimen). PTSPEC=SMOKE to indicate the specimen type is smoke.

Row 18:Shows one 1 analyte was tested with a different smoking regimen (Canadian intense regimenPTREFID=INTENSE REGIMEN) using the same smoking machine.
Row 19:Shows one 1 analyte was tested in the tobacco filler (PTSPEC). Thus SPDEVID and PTREFID are null.
Dataset2
RowSTUDYIDDOMAINSPTOBIDSPDEVIDPTSEQPTREFID
PTCAS
PTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPEC
PTMETHOD
PTREPNUMPTDTC
1TOB07PTCIG01aPUFFMASTER3K1
ISO
NON-INTENSE REGIMEN
75-07-0
ACTALDAcetaldehydeHPHC TESTINGHPHC522
µg
ug/cigarette522522
µg
ug/cigaretteTL001_V5.pdfTPT LABCOSMOKE
TL001 Ver 5
12022-09-30
2TOB07PTCIG01aPUFFMASTER3K2
ISO
NON-INTENSE REGIMEN
107-02-8
ACROLEINAcroleinHPHC TESTINGHPHC43
µg
ug/cigarette4343
µg
ug/cigaretteTL002_V3.6.pdfTPT LABCOSMOKE
L002 V 3.6
12022-09-30
3TOB07PTCIG01aPUFFMASTER3K3
ISO
NON-INTENSE REGIMEN
107-13-1
ACRYNTRLAcrylonitrileHPHC TESTINGHPHC7
µg
ug/cigarette77
µg
ug/cigaretteTL006_V6.pdfTPT LABCOSMOKE
L006 V6
12022-09-30
4TOB07PTCIG01aPUFFMASTER3K4
ISO
NON-INTENSE REGIMEN
92-67-1
ABP44-AminobiphenylHPHC TESTINGHPHC1.2ng/cigarette1.21.2ng/cigaretteTL008_V3.pdfTPT LABCOSMOKE12022-09-30
5TOB07PTCIG01aPUFFMASTER3K5
ISO
NON-INTENSE REGIMEN
134-32-7
AMNPHTH11-AminonaphthaleneHPHC TESTINGHPHC14ng/cigarette1414ng/cigaretteTL003_V1.4.pdfTPT LABCOSMOKE12022-09-30
6TOB07PTCIG01aPUFFMASTER3K6
ISO
NON-INTENSE REGIMEN
134-32-7
AMNPHTH22-AminonaphthaleneHPHC TESTINGHPHC8ng/cigarette88ng/cigaretteTL003_V1.4.pdfTPT LABCOSMOKE12022-09-30
7TOB07PTCIG01aPUFFMASTER3K7
ISO
NON-INTENSE REGIMEN
7664-41-7
AMMONIAAmmoniaHPHC TESTINGHPHC9
µg
ug/cigarette99
µg
ug/cigaretteTL020_V4.pdfTPT LABCOSMOKE12022-09-30
8TOB07PTCIG01aPUFFMASTER3K8
ISO
NON-INTENSE REGIMEN
71-43-2
BENZENEBenzeneHPHC TESTINGHPHC33
µg
ug/cigarette3333
µg
ug/cigaretteTL017_V1.1.pdfTPT LABCOSMOKE12022-09-30
9TOB07PTCIG01aPUFFMASTER3K9
ISO
NON-INTENSE REGIMEN
50-32-8
BZAPYRBenzo[a]pyreneHPHC TESTINGHPHC6.8ng/cigarette6.86.8ng/cigaretteTL017_V1.1.pdfTPT LABCOSMOKE12022-09-30
10TOB07PTCIG01aPUFFMASTER3K10
ISO
NON-INTENSE REGIMEN
630-08-0
CMONOXCarbon MonoxideHPHC TESTINGHPHC10.1mg/cigarette10.110.1mg/cigaretteTL019_V3.pdfTPT LABCOSMOKE12022-09-30
11TOB07PTCIG01aPUFFMASTER3K11
ISO
NON-INTENSE REGIMEN
4170-30-3
CROTNALDCrotonaldehydeHPHC TESTINGHPHC11
µg
ug/cigarette1111
µg
ug/cigaretteTL001_V5.pdfTPT LABCOSMOKE12022-09-30
12TOB07PTCIG01aPUFFMASTER3K12
ISO
NON-INTENSE REGIMEN
50-00-0
FORMALDFormaldehydeHPHC TESTINGHPHC27
µg
ug/cigarette2727
µg
ug/cigaretteTL001_V5.pdfTPT LABCOSMOKE12022-09-30
13TOB07PTCIG01aPUFFMASTER3K13
ISO
NON-INTENSE REGIMEN
78-79-5
ISOPRENEIsopreneHPHC TESTINGHPHC320
µg
ug/cigarette320320
µg
ug/cigaretteTL041_V1.pdfTPT LABCOSMOKE12022-09-30
14TOB07PTCIG01aPUFFMASTER3K14
ISO
NON-INTENSE REGIMEN
1954-11-05
NICOTINENicotineHPHC TESTINGHPHC0.721mg/cigarette0.7210.721mg/cigaretteTL007_V2.1.pdfTPT LABCOSMOKE12022-09-30
15TOB07PTCIG01aPUFFMASTER3K15
ISO
NON-INTENSE REGIMEN
64091-91-4
NNKNicotine-Derived Nitrosamine KetoneHPHC TESTINGHPHC71ng/cigarette7171ng/cigaretteTL026_V12.2.pdfTPT LABCOSMOKE12022-09-30
16TOB07PTCIG01aPUFFMASTER3K16
ISO
NON-INTENSE REGIMEN
16543-55-8
NNNN-NitrosonornicotineHPHC TESTINGHPHC85ng/cigarette8585ng/cigaretteTL026_V12.2.pdfTPT LABCOSMOKE12022-09-30
17TOB07PTCIG01aPUFFMASTER3K17
ISO
NON-INTENSE REGIMEN
108-88-3
TOLUENETolueneHPHC TESTINGHPHC53
µg
ug/cigarette5353
µg
ug/cigaretteTL011_V3.3.pdfTPT LABCOSMOKE12022-09-30
18TOB07PTCIG01aPUFFMASTER3K18
CANADIAN
INTENSE REGIMEN
75-07-0
ACTALDAcetaldehydeHPHC TESTINGHPHC1552
µg
ug/cigarette15521552
µg
ug/cigaretteTL009_V4.3.pdfTPT LABCOSMOKE12022-09-30
19TOB07PTCIG01a
PUFFMASTER3K

19
7664-41-7

AMMONIAAmmoniaHPHC TESTINGHPHC956
µg
ug/g956956
µg
ug/cigaretteTL016_V1.2.pdfTPT LABCOTOBACCO FILLER12022-09-30

The identifying characteristics of the smoking machine are represented in the Device Identifiers reference dataset. DI is the source of the sponsorapplicant-defined device ID variable (SPDEVID) used in the PT dataset to indicate the smoking machine used to perform the smoking regimen.

...

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 above by matching values of PTREFID/DUREFID.

Dataset wrap
Namedu
Rowcaps
Rows 1-9:Show the parameters of the ISO non-intense smoking regimen.
Rows 8-9:Note the use of PTGRPID DUGRPID to group these records together to indicate that puff pause and puff pause interval are related records. Taken together, they tell us indicate that this smoking regimen pauses for 60 seconds every 10 puffs.
Rows 10-18:Show the parameters of the Canadian intense smoking regimen.
Rows 17-18:Note the use of PTGRPID DUGRPID to group these records together to indicate that puff pause and puff pause interval are related records. Taken together, they tell us indicate that this smoking regimen pauses for 30 seconds every 10 puffs.
Dataset2

Row

STUDYIDDOMAINSPDEVIDDUSEQDUREFIDDUGRPIDDUTESTCDDUTESTDUORRESDUORRESUDUSTRESCDUSTRESNDUSTRESU
1

TOB07

DUPUFFMASTER3K1ISO NON-INTENSE METHODREGIMEN
PUFFPROFPuff ProfileSQUARE
SQUARE

2

TOB07

DUPUFFMASTER3K2ISO NON-INTENSE METHODREGIMEN

PUFFDUR

Puff Duration

1.25

sec

1.25

1.25

sec

3

TOB07

DUPUFFMASTER3K3ISO NON-INTENSE METHODREGIMEN

PUFFINT

Puff Interval

3

PUFF/min

3

3

PUFF/min

4

TOB07

DUPUFFMASTER3K4ISO NON-INTENSE METHODREGIMEN

PUFFBLCK

Puff Block

25

%

25

25

%

5

TOB07

DUPUFFMASTER3K5ISO NON-INTENSE METHODREGIMEN
NUMPUFF

PUFFNUM

Total Number of Puffs

200

PUFF

200

200

PUFF

6

TOB07

DUPUFFMASTER3K6ISO NON-INTENSE METHODREGIMEN
PUFFVOLPuff Volume

10

mL

10

10

mL

7

TOB07

DUPUFFMASTER3K7ISO NON-INTENSE METHODREGIMEN
PUFFRNGPuff Range

100-200


100-200



8

TOB07

DUPUFFMASTER3K8ISO NON-INTENSE METHODREGIMEN1PUFFPAUSPuff Pause

60

s

60

60

s

9TOB07DUPUFFMASTER3K9ISO NON-INTENSE METHODREGIMEN1PUFFPINTPuff Pause Interval

10

PUFF

10

10

PUFF

10

TOB07

DUPUFFMASTER3K1CANADIAN INTENSE METHODREGIMEN
PUFFPROFPuff ProfileSQUARE
SQUARE

11

TOB07

DUPUFFMASTER3K2CANADIAN INTENSE METHODREGIMEN

PUFFDUR

Puff Duration

12.525

sec

12.525

1
2.525

sec

12

TOB07

DUPUFFMASTER3K3CANADIAN INTENSE METHODREGIMEN

PUFFINT

Puff Interval

3

PUFF/min

3

3

PUFF/min

13

TOB07

DUPUFFMASTER3K4CANADIAN INTENSE METHODREGIMEN

PUFFBLCK

Puff Block

30

%

30

30

%

14

TOB07

DUPUFFMASTER3K5CANADIAN INTENSE METHODREGIMEN
NUMPUFFPUFFNUMTotal Number of Puffs

100

PUFF

100

100

PUFF

15

TOB07

DUPUFFMASTER3K6CANADIAN INTENSE METHODREGIMEN
PUFFVOLPuff Volume

1020

mL

1020

10
20

mL

16

TOB07

DUPUFFMASTER3K7CANADIAN INTENSE METHODREGIMEN
PUFFRNGPuff Range

50-150


50-150



17

TOB07

DUPUFFMASTER3K8CANADIAN INTENSE METHODREGIMEN2PUFFPAUSPuff Pause

30

s

30

30

s

18TOB07DUPUFFMASTER3K9CANADIAN INTENSE METHODREGIMEN2PUFFPINTPuff Pause Interval

10

PUFF

10

10

PUFF