Versions Compared

Old Version 38

changes.mady.by.user Jon Neville

Saved on

compared with

New Version Current

changes.mady.by.user Alana St. Clair

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

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

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 from the tobacco product identified in SPTOBID (CIG01a).

SPDEVID indicates

Note of the use of SPDEVID as the device identifier for 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.

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 nullRows 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.
Dataset2
RowSTUDYIDDOMAINSPTOBIDSPDEVIDPTSEQPTREFID
PTCAS
PTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPEC
PTMETHOD
PTREPNUMPTDTC
1TOB07PTCIG01aPUFFMASTER3K1
75-07-0
NON-INTENSE REGIMENACTALDAcetaldehydeHPHC TESTINGHPHC522
µg
ug/cigarette522522
µg
ug/cigaretteTL001_V5.pdfTPT LABCO
TOBACCOISO METHOD
SMOKE12022-09-30
2TOB07PTCIG01aPUFFMASTER3K2
107-02-8
NON-INTENSE REGIMENACROLEINAcroleinHPHC TESTINGHPHC43
µg
ug/cigarette4343
µgISO METHOD
ug/cigaretteTL002_V3.6.pdfTPT LABCO
TOBACCO
SMOKE12022-09-30
3TOB07PTCIG01aPUFFMASTER3K3
107-13-1
NON-INTENSE REGIMENACRYNTRLAcrylonitrileHPHC TESTINGHPHC7
µg
ug/cigarette77
µgISO METHOD
ug/cigaretteTL006_V6.pdfTPT LABCO
TOBACCO
SMOKE12022-09-30
4TOB07PTCIG01aPUFFMASTER3K4
92-67-1
NON-INTENSE REGIMENABP44-AminobiphenylHPHC TESTINGHPHC1.2ng/cigarette1.21.2ng/cigaretteTL008_V3.pdfTPT LABCO
TOBACCO
SMOKE
ISO METHOD
12022-09-30
5TOB07PTCIG01aPUFFMASTER3K5
134-32-7
NON-INTENSE REGIMENAMNPHTH11-AminonaphthaleneHPHC TESTINGHPHC14ng/cigarette1414ng/cigaretteTL003_V1.4.pdfTPT LABCO
TOBACCO
SMOKE
ISO METHOD
12022-09-30
6TOB07PTCIG01aPUFFMASTER3K6
134-32-7
NON-INTENSE REGIMENAMNPHTH22-AminonaphthaleneHPHC TESTINGHPHC8ng/cigarette88ng/cigaretteTL003_V1.4.pdfTPT LABCO
TOBACCO
SMOKE
ISO METHOD
12022-09-30
7TOB07PTCIG01aPUFFMASTER3K7
7664-41-7
NON-INTENSE REGIMENAMMONIAAmmoniaHPHC TESTINGHPHC9
µg
ug/cigarette99
µgISO METHOD
ug/cigaretteTL020_V4.pdfTPT LABCO
TOBACCO
SMOKE12022-09-30
8TOB07PTCIG01aPUFFMASTER3K8
71-43-2
NON-INTENSE REGIMENBENZENEBenzeneHPHC TESTINGHPHC33
µg
ug/cigarette3333
µg
ug/cigaretteTL017_V1.1.pdfTPT LABCO
TOBACCO
SMOKE
ISO METHOD
12022-09-30
9TOB07PTCIG01aPUFFMASTER3K9
50-32-8
NON-INTENSE REGIMENBZAPYRBenzo[a]pyreneHPHC TESTINGHPHC6.8ng/cigarette6.86.8ng/cigaretteTL017_V1.1.pdfTPT LABCO
TOBACCO
SMOKE
ISO METHOD
12022-09-30
10TOB07PTCIG01aPUFFMASTER3K10
630-08-0ISO METHOD
NON-INTENSE REGIMENCMONOXCarbon MonoxideHPHC TESTINGHPHC10.1mg/cigarette10.110.1mg/cigaretteTL019_V3.pdfTPT LABCO
TOBACCO
SMOKE12022-09-30
11TOB07PTCIG01aPUFFMASTER3K11
4170-30-3
NON-INTENSE REGIMENCROTNALDCrotonaldehydeHPHC TESTINGHPHC11
µg
ug/cigarette1111
µg
ug/cigaretteTL001_V5.pdfTPT LABCO
TOBACCO
SMOKE
ISO METHOD
12022-09-30
12TOB07PTCIG01aPUFFMASTER3K12
50-00-0
NON-INTENSE REGIMENFORMALDFormaldehydeHPHC TESTINGHPHC27
µg
ug/cigarette2727
µg
ug/cigaretteTL001_V5.pdfTPT LABCO
TOBACCO
SMOKE
ISO METHOD
12022-09-30
13TOB07PTCIG01aPUFFMASTER3K13
78-79-5
NON-INTENSE REGIMENISOPRENEIsopreneHPHC TESTINGHPHC320
µg
ug/cigarette320320
µgISO METHOD
ug/cigaretteTL041_V1.pdfTPT LABCO
TOBACCO1954-11-05
SMOKE12022-09-30
14TOB07PTCIG01aPUFFMASTER3K14
Medium Intensity Regimen
NON-INTENSE REGIMENNICOTINENicotineHPHC TESTINGHPHC0.721mg/cigarette0.7210.721mg/cigaretteTL007_V2.1.pdfTPT LABCOSMOKE
ISO METHOD64091-91-4
12022-09-30
15TOB07PTCIG01aPUFFMASTER3K15
Medium Intensity Regimen
NON-INTENSE REGIMENNNKNicotine-Derived Nitrosamine KetoneHPHC TESTINGHPHC71ng/cigarette7171ng/cigaretteTL026_V12.2.pdfTPT LABCOSMOKE
ISO METHOD16543-55-8
12022-09-30
16TOB07PTCIG01aPUFFMASTER3K16
Medium Intensity Regimen
NON-INTENSE REGIMENNNNN-NitrosonornicotineHPHC TESTINGHPHC85ng/cigarette8585ng/cigaretteTL026_V12.2.pdfTPT LABCOSMOKE
ISO METHOD
12022-09-30
17TOB07PTCIG01aPUFFMASTER3K17
108-88-3
NON-INTENSE REGIMENTOLUENETolueneHPHC TESTINGHPHC53
µg
ug/cigarette5353
µg
ug/cigaretteTL011_V3.3.pdfTPT LABCO
TOBACCO
SMOKE
ISO METHOD
12022-09-30
18TOB07PTCIG01aPUFFMASTER3K18
75-07-0
INTENSE REGIMENACTALDAcetaldehydeHPHC TESTINGHPHC1552
µg
ug/cigarette15521552
µg
ug/cigaretteTL009_V4.3.pdfTPT LABCO
TOBACCO
SMOKE
CANADIAN INTENSE METHOD
12022-09-30
19TOB07PTCIG01a
19
7664-41-7

AMMONIAAmmoniaHPHC TESTINGHPHC956
µg
ug/g956956
µg
ug/cigaretteTL016_V1.2.pdfTPT LABCOTOBACCO FILLER
CANADIAN INTENSE METHOD
12022-09-30

The 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 smoking regimen.

Dataset wrap
titlelb.xpt
Namedi
Dataset2
RowSTUDYIDDOMAINSPDEVIDDISEQDIPARMCDDIPARMDIVAL
1TOB07DIPUFFMASTER3K1DEVTYPEDevice TypeSmoking 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 above by matching values of PTREFID/DUREFID = "Medium Intensity Regimen". 

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

DUPUFFMASTER3K1Medium Intensity RegimenNON-INTENSE REGIMEN
PUFFPROFPuff ProfileSQUARE
SQUARE

2

TOB07

DUPUFFMASTER3K2Medium Intensity RegimenNON-INTENSE REGIMEN

PUFFDUR

Puff Duration

1.25

sec

1.25

1.25

sec

3

TOB07

DUPUFFMASTER3K3Medium Intensity RegimenNON-INTENSE REGIMEN

PUFFINT

Puff Interval

3

PUFF/min

3

3

PUFF/min

4

TOB07

DUPUFFMASTER3K4Medium Intensity RegimenNON-INTENSE REGIMEN

PUFFBLCK

Puff Block

25

%

25

25

%

5

TOB07

DUPUFFMASTER3K5Medium Intensity RegimenNUMPUFFNON-INTENSE REGIMEN

PUFFNUM

Total Number of Puffs

200

PUFF

200

200

PUFF

6

TOB07

DUPUFFMASTER3K6Medium Intensity RegimenNON-INTENSE REGIMEN
PUFFVOLPuff Volume

10

mL

10

10

mL

7

TOB07

DUPUFFMASTER3K7Medium Intensity RegimenNON-INTENSE REGIMEN
PUFFRNGPuff Range

100-200


100-200



8

TOB07

DUPUFFMASTER3K8Medium Intensity RegimenNON-INTENSE REGIMEN1PUFFPAUSPuff Pause

60

s

60

60

s

9TOB07DUPUFFMASTER3K9Medium Intensity RegimenNON-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 REGIMEN21PUFFPINTPuff Pause Interval

10

PUFF

10

10

PUFF