The examples in this section illustrate how to represent lists of design parameter specifications and testing for conformance to those specifications using three tobacco product categories: cigarettes (Example 1), ENDS devices (Example 2), and smokeless tobacco products (Example 3). Each example starts with a TO dataset, followed by a Product Design Parameters (PD) dataset and a Tobacco Product Testing (PT) dataset.

Note that tobacco product testing for conformance to design parameters would typically require multiple replicates for each parameter being tested. In SDTM, each replicate would be represented in its own record, differentiated by using the PTREPNUM variable (repetition number), which would be set to values of 1 through (where n = the total number of replicates being tested).  For simplicity of review, each example uses the PTREPNUM variable, but only for 1 record (1 repetition). In reality, if only 1 record for a given parameter or analyte is collected, the PTREPNUM variable would not be used.

Example

This example illustrates the representation of a cigarette product's identifiers and descriptors using the TO domain. Note that this example uses TOSCAT (Subcategory of Tobacco Prod ID Element, a permissible variable) to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors. 

to.xpt

to.xpt

RowSTUDYIDDOMAINSPTOBIDTOSEQTOPARMCDTOPARMTOCATTOSCATTOVALTOVALU
1TOB07TOCIG01a

1

TBPRDCATTobacco Product CategoryNEW PRODUCTPRODUCT IDENTIFIERCigarettes
2TOB07TOCIG01a2TBPRSCATTobacco Product SubcategoryNEW PRODUCTPRODUCT IDENTIFIERFiltered
3TOB07TOCIG01a3MANUFManufacturerNEW PRODUCTPRODUCT IDENTIFIERJoes Cigs USA
4TOB07TOCIG01a4TRADENAMTrade NameNEW PRODUCTPRODUCT IDENTIFIERTreetop Menthol King Size
5TOB07TOCIG01a5PACKTYPPackage TypeNEW PRODUCTPRODUCT DESCRIPTORHARD PACK
6TOB07TOCIG01a6PRDQUANProduct QuantityNEW PRODUCTPRODUCT DESCRIPTOR20CIGARETTE
7TOB07TOCIG01a7LENGTHLengthNEW PRODUCTPRODUCT DESCRIPTOR86.0mm
8TOB07TOCIG01a8CIRCUMFCircumferenceNEW PRODUCTPRODUCT DESCRIPTOR26.0mm
9TOB07TOCIG01a9VENTLTOTTotal VentilationNEW PRODUCTPRODUCT DESCRIPTOR10.0%
10TOB07TOCIG01a10CHARFLAVCharacterizing FlavorNEW PRODUCTPRODUCT DESCRIPTORMENTHOL
$warningHtml

The manufacturing parameter specifications of the cigarette tobacco product as intended for use are represented in the PD domain  The following example shows the target, minimum, and maximum values associated with each of 23 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.

Note the use of the variable IGDCMPID (Ingredient or Component Identifier) in rows 5-6. This tobacco product had 2 tobacco ingredients with 2 different tobacco cut sizes. IGDCMPID identifies to which tobacco ingredient the cut size applies. IGDCMPID originates in the IT (Tobacco Ingredients) and IN (Non-Tobacco Ingredients) domains. See Section 3.1.3.1, Ingredients and Additives, for more information.

pd.xpt

pd.xpt

RowSTUDYIDDOMAINSPTOBIDIGDCMPIDPDSEQPDPARMCDPDPARMPDVALTRGPDVALMINPDVALMAXPDVALU
1

TOB07

PDCIG01a


1

LENGTHLength

84

83.5

84.5

mm

2TOB07PDCIG01a
2CIRCUMFCircumference24.824.625mm
3TOB07PDCIG01a
3TBFLMASSTobacco Filler Mass783753814mg
4TOB07PDCIG01a
4MOISTUREMoisture131214%
5TOB07PDCIG01a

Burley tobacco

5TOCUTSIZTobacco Cut Size

22

20

24

cuts/in

6TOB07PDCIG01a

Reconstituted tobacco

6TOCUTSIZTobacco Cut Size

27

25

29

mm

7TOB07PDCIG01a


7VENTLFLTFilter Ventilation

30

23

37

%

8TOB07PDCIG01a
8TPNPLGTHTipping Paper Length313032mm
9TOB07PDCIG01a
9CBPPOR

Cigarette Base Paper Porosity

50

45

55Cu
10TOB07PDCIG01a


10CBPPERMCigarette Base Paper Permeability

50

45

55

Cu

11TOB07PDCIG01a
11CPBPORCigarette Paper Band Porosity100.213Cu
12TOB07PDCIG01a
12CPBPERMCigarette Paper Band Permeability100.213Cu
13TOB07PDCIG01a
13

CPBDIFF

Cigarette Paper Band Diffusivity0.050.0010.100cm2/s
14TOB07PDCIG01a


14CPBWIDCigarette Paper Band Width

7

6.7

7.3

mm

15TOB07PDCIG01a


15CPBSPCCigarette Paper Band Space20

19.8

20.2

mm

16TOB07PDCIG01a


16FLTREFFFilter Efficiency

30

25

35

%

17TOB07PDCIG01a


17DPFDenier Per Filament43.64.4


18TOB07PDCIG01a


18TDENIERTotal Denier

30000

29100

30900

g/9000m

19TOB07PDCIG01a
19FLTRDENFilter Density0.12340.1050.1419g/cm3
20TOB07PDCIG01a
20FLTRLGTHFilter Length2524.525.5mm
21TOB07PDCIG01a
21FLTPRDRPFilter Pressure Drop605169mm H2O
22TOB07PDCIG01a
22TORODDENTobacco Rod Density0.26780.24370.2919g/cm3
23TOB07PDCIG01a
23CIGPLGTHCigarette Paper Length535254mm
$warningHtml

Finally, the PT domain is used to represent the actual results of testing the manufactured cigarette product for conformance to the tobacco product design parameters shown in PD above. PTCAT is a Required variable and is set to "DESIGN PARAMETER TESTING" for all records here. As described in the PD example, IGDCMPID is also used here to differentiate 2 records of the same test performed on each of 2 different types of tobacco that are ingredients of the tobacco product. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only 1 replicate per parameter is shown. Note that PTREPNUM (repetition number) = 1 for all rows.

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDIGDCMPIDPTSEQPTTESTCDPTTESTPTCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTMETHODPTREPNUM
1TOB07PTCIG01a

1

LENGTHLengthDESIGN PARAMETER TESTING

83.9

mm

83.9

83.9

mm
1
2TOB07PTCIG01a
2CIRCUMFCircumferenceDESIGN PARAMETER TESTING24.9mm24.924.9mm
1
3TOB07PTCIG01a
3TBFLMASSTobacco Filler MassDESIGN PARAMETER TESTING779mg779779mg
1
4TOB07PTCIG01a
4MOISTUREMoistureDESIGN PARAMETER TESTING13.1%13.113.1%
1
5TOB07PTCIG01a

Burley tobacco

5TOCUTSIZTobacco Cut SizeDESIGN PARAMETER TESTING22cuts/in2222cuts/in
1
6TOB07PTCIG01a

Reconstituted tobacco

6TOCUTSIZTobacco Cut SizeDESIGN PARAMETER TESTING27mm2727mm
1
7TOB07PTCIG01a
7VENTLFLTFilter VentilationDESIGN PARAMETER TESTING35%3535%
1
8TOB07PTCIG01a
8TPNPLGTHTipping Paper LengthDESIGN PARAMETER TESTING30mm3030mm
1
9TOB07PTCIG01a
9CBPPORCigarette Base Paper PorosityDESIGN PARAMETER TESTING48Cu4848Cu
1
10TOB07PTCIG01a
10CBPPERMCigarette Base Paper PermeabilityDESIGN PARAMETER TESTING50Cu5050Cu
1
11TOB07PTCIG01a
11CPBPORCigarette Paper Band PorosityDESIGN PARAMETER TESTING9.8Cu9.89.8Cu
1
12TOB07PTCIG01a
12CPBPERMCigarette Paper Band PermeabilityDESIGN PARAMETER TESTING10Cu1010Cu
1
13TOB07PTCIG01a
13CPBDIFFCigarette Paper Band DiffusivityDESIGN PARAMETER TESTING0.06cm2/s0.060.06cm2/s
1
14TOB07PTCIG01a
14CPBWIDCigarette Paper Band WidthDESIGN PARAMETER TESTING7.1mm7.17.1mm
1
15TOB07PTCIG01a
15CPBSPCCigarette Paper Band SpaceDESIGN PARAMETER TESTING19.9mm19.919.9mm
1
16TOB07PTCIG01a
16FLTREFFFilter EfficiencyDESIGN PARAMETER TESTING28%2828%
1
17TOB07PTCIG01a
17DPFDenier Per FilamentDESIGN PARAMETER TESTING4.1
4.14.1

1
18TOB07PTCIG01a
18TDENIERTotal DenierDESIGN PARAMETER TESTING29900g/9000m2990029900g/9000m
1
19TOB07PTCIG01a
19FLTRDENFilter DensityDESIGN PARAMETER TESTING0.1112g/cm30.11120.1112g/cm3
1
20TOB07PTCIG01a
20FLTRLGTHFilter LengthDESIGN PARAMETER TESTING25mm2525mm
1
21TOB07PTCIG01a
21FLTPRDRPFilter Pressure DropDESIGN PARAMETER TESTING62mm H2O6262mm H2O
1
22TOB07PTCIG01a
22TORODDENTobacco Rod DensityDESIGN PARAMETER TESTING0.2701g/cm30.27010.2701g/cm3
1
23TOB07PTCIG01a
23CIGPLGTHCigarette Paper LengthDESIGN PARAMETER TESTING53mm5353mm
1
$warningHtml

References:

  1. International Organization for Standardization. ISO 9512:2019(en) - Cigarettes — Determination of ventilation — Definitions and measurement principles. ISO; June 2019. Accessed October 15, 2023. https://www.iso.org/obp/ui/#iso:std:iso:9512:ed-3:v1:en
  2. Song M-A, Benowitz NL, Berman M, et al. Cigarette filter ventilation and its relationship to increasing rates of lung adenocarcinoma. J Natl Cancer Inst. 2017;109(12):djx075. https://doi.org/10.1093/jnci/djx075

Example

The following example illustrates the representation of an ENDS tobacco product's identifiers and descriptors using the TO domain. Note that this example uses TOSCAT to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.

to.xpt

to.xpt

RowSTUDYIDDOMAINSPTOBIDTOSEQTOPARMCDTOPARMTOCATTOSCATTOVALTOVALU
1TOB09TOVAPE-Z27

1

TBPRDCATTobacco Product CategoryNEW PRODUCTPRODUCT IDENTIFIERElectronic Nicotine Delivery Systems (ENDS) (Vapes)
2TOB09TOVAPE-Z272TBPRSCATTobacco Product SubcategoryNEW PRODUCTPRODUCT IDENTIFIERClosed E-Cigarette
3TOB09TOVAPE-Z273MANUFManufacturerNEW PRODUCTPRODUCT IDENTIFIERJoes Vapes USA
4TOB09TOVAPE-Z274TRADENAMTrade NameNEW PRODUCTPRODUCT IDENTIFIEREveryday Rich Tobacco
5TOB09TOVAPE-Z275PACKTYPPackage TypeNEW PRODUCTPRODUCT DESCRIPTORBOX
6TOB09TOVAPE-Z276PRDQUANProduct QuantityNEW PRODUCTPRODUCT DESCRIPTOR1E-CIGARETTE
7TOB09TOVAPE-Z277LENGTHLengthNEW PRODUCTPRODUCT DESCRIPTOR107.2mm
8TOB09TOVAPE-Z278DIAMETERDiameterNEW PRODUCTPRODUCT DESCRIPTOR9mm
9TOB09TOVAPE-Z279NICTNCNCNicotine ConcentrationNEW PRODUCTPRODUCT DESCRIPTOR2mg/L
10TOB09TOVAPE-Z2710PRPYLGLYPropylene GlycolNEW PRODUCTPRODUCT DESCRIPTOR50%
11TOB09TOVAPE-Z2711VEGGLYVegetable GlycerinNEW PRODUCTPRODUCT DESCRIPTOR50%
12TOB09TOVAPE-Z2712CHARFLAVCharacterizing FlavorNEW PRODUCTPRODUCT DESCRIPTORTobacco
13TOB09TOVAPE-Z2713ELQDVOL

E-Liquid Volume

NEW PRODUCTPRODUCT DESCRIPTOR1mL
14TOB09TOVAPE-Z2714BATCAPCBattery CapacityNEW PRODUCTPRODUCT DESCRIPTOR600mAh
15TOB09TOVAPE-Z2715DSCRTINDDisposable Cartridge IndicatorNEW PRODUCTPRODUCT DESCRIPTORY
$warningHtml

The manufacturing parameter specifications of the ENDS product as intended for used are represented in the PD domain. The following example shows the target, minimum, and maximum values associated with each of 33 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally. 

pd.xpt

pd.xpt

RowSTUDYIDDOMAINSPTOBIDPDSEQPDPARMCDPDPARMPDVALTRGPDVALMINPDVALMAXPDVALU
1TOB09PDVAPE-Z27

1

DRWRSTDraw Resistance90.080.0120.0mm H2O
2TOB09PDVAPE-Z272PUFCNTPuff Count300290310
3TOB09PDVAPE-Z273CRTVOLCartridge Volume315mL
4TOB09PDVAPE-Z274HTELNUMNumber of Heating Elements11

1


5TOB09PDVAPE-Z275HTELGTHHeating Element Length32.73.3mm
6TOB09PDVAPE-Z276HTEDIAMHeating Element Diameter32.93.2mm
7TOB09PDVAPE-Z277HTELRSTHeating Element Resistance0.750.251.5ohm
8TOB09PDVAPE-Z278HTELRNGHeating Element Range175100250C
9TOB09PDVAPE-Z279HTELCFGHeating Element ConfigurationSPIRALSPIRALSPIRAL
10TOB09PDVAPE-Z2710BTVLTORG

Battery Voltage Operating Range

4.536V
11TOB09PDVAPE-Z2711BTCRTORG

Battery Current Operating Range

10006501600mAh
12TOB09PDVAPE-Z2712BATCAPCBattery Capacity11008003000mAh
13TOB09PDVAPE-Z2713BATNOMV

Battery Nominal Voltage

4.24.04.5V
14TOB09PDVAPE-Z2714BTCRTRTBattery Current Rating250020002800mA
15TOB09PDVAPE-Z2715BTCHTPLBattery Charging Temperature Limits200100315C
16TOB09PDVAPE-Z2716BTDCTMPLBattery Discharge Temperature Limits20-2060C
17TOB09PDVAPE-Z2717BTENDCVBattery End of Discharge Voltage3.02.03.5V
18TOB09PDVAPE-Z2718BTMXCHCBattery Maximum Charging Current242030mA
19TOB09PDVAPE-Z2719BTMXDCC

Battery Maximum Discharging Current

270024003000mA
20TOB09PDVAPE-Z2720BTULCHVBattery Upper Limits Charging Voltage4.24.14.3V
21TOB09PDVAPE-Z2721PDUVORPDU Voltage Operating Range3.73.24.2V
22TOB09PDVAPE-Z2722PDUCORPDU Current Operating Range12008501800mA
23TOB09PDVAPE-Z2723PDUTCTOFPDU Temperature Cut-off705565C
24TOB09PDVAPE-Z2724AIRFLRTAirflow Rate720700740L/min
25TOB09PDVAPE-Z2725PDUCRCOFPDU Current Cut-off352050mA
26TOB09PDVAPE-Z2726INHAERTInhaled Aerosol Temperature373540C
27TOB09PDVAPE-Z2727VENTLTOTTotal Ventilation504060%
28TOB09PDVAPE-Z2728ELQDVISCE-Liquid Viscosity500751130mPa/s
29TOB09PDVAPE-Z2729ELQDVOLE-liquid Volume6010120mL
30TOB09PDVAPE-Z2730PNUMCNCParticle Number Concentration5001081010/cm3
31TOB09PDVAPE-Z2731CTMDDIAMCount Median Diameter200150250nm
32TOB09PDVAPE-Z2732PM2.5Particulate Matter 2.5251235ug/m3
$warningHtml

Finally, the PT domain is used to represent the actual results of testing the manufactured ENDS product for conformance to the tobacco product design parameters shown in PD. PTCAT is a Required variable and is set to "DESIGN PARAMETER TESTING" for all records here. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only 1 replicate per parameter is shown. Note that PTREPNUM (repetition number) = 1 for all rows. 

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDPTSEQPTREFIDPTTESTCDPTTESTPTTSTCNDPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESU

PTREPNUM

1TOB09PTVAPE-Z27

1


DRWRSTDraw Resistance
DESIGN PARAMETER TESTING
91mm H2O9191mm H2O1
2TOB09PTVAPE-Z272
PUFCNTPuff Count
DESIGN PARAMETER TESTING
309
309309
1
3TOB09PTVAPE-Z273
CRTVOLCartridge Volume
DESIGN PARAMETER TESTING
3.09mL3.093.09mL1
4TOB09PTVAPE-Z274
HTELNUMNumber of Heating Elements
DESIGN PARAMETER TESTING
1
11
1
5TOB09PTVAPE-Z275
HTELGTHHeating Element Length
DESIGN PARAMETER TESTING
2.97mm2.972.97mm1
6TOB09PTVAPE-Z276
HTEDIAMHeating Element Diameter
DESIGN PARAMETER TESTING
3.05mm3.053.05mm

1

7TOB09PTVAPE-Z277
HTELRSTHeating Element Resistance
DESIGN PARAMETER TESTING
0.77ohm0.770.77ohm1
8TOB09PTVAPE-Z278
HTELRNGHeating Element Range
DESIGN PARAMETER TESTING
174C174174C1
9TOB09PTVAPE-Z279
HTELCFGHeating Element Configuration
DESIGN PARAMETER TESTING
SPIRAL
SPIRALSPIRAL
1
10TOB09PTVAPE-Z2710
BTVLTORG

Battery Voltage Operating Range


DESIGN PARAMETER TESTING
4.6V4.64.6V1
11TOB09PTVAPE-Z2711
BTCRTORG

Battery Current Operating Range


DESIGN PARAMETER TESTING
997mAh997997mAh1
12TOB09PTVAPE-Z2712
BATCAPCBattery Capacity
DESIGN PARAMETER TESTING
1112mAh11121112mAh1
13TOB09PTVAPE-Z2713
BATNOMV

Battery Nominal Voltage


DESIGN PARAMETER TESTING
4.18V4.184.18V1
14TOB09PTVAPE-Z2714
BTCRTRTBattery Current Rating
DESIGN PARAMETER TESTING
2488mA24882488mA1
15TOB09PTVAPE-Z2715
BTCHTPLBattery Charging Temperature Limits
DESIGN PARAMETER TESTING
198C198198C1
16TOB09PTVAPE-Z2716
BTDCTMPLBattery Discharge Temperature Limits
DESIGN PARAMETER TESTING
19C1919C1
17TOB09PTVAPE-Z2717
BTENDCVBattery End of Discharge Voltage
DESIGN PARAMETER TESTING
3.03V3.033.03V1
18TOB09PTVAPE-Z2718
BTMXCHCBattery Maximum Charging Current
DESIGN PARAMETER TESTING
23.5mA23.523.5mA1
19TOB09PTVAPE-Z2719
BTMXDCC

Battery Maximum Discharging Current


DESIGN PARAMETER TESTING
2696mA26962696mA1
20TOB09PTVAPE-Z2720
BTULCHVBattery Upper Limits Charging Voltage
DESIGN PARAMETER TESTING
4.21V4.214.21V1
21TOB09PTVAPE-Z2721
PDUVORPDU Voltage Operating Range
DESIGN PARAMETER TESTING
3.65V3.653.65V1
22TOB09PTVAPE-Z2722
PDUCORPDU Current Operating Range
DESIGN PARAMETER TESTING
1202mA12021202mA1
23TOB09PTVAPE-Z2723
PDUTCTOFPDU Temperature Cut-off
DESIGN PARAMETER TESTING
69.9C69.969.9C1
24TOB09PTVAPE-Z2724
AIRFLRTAirflow Rate
DESIGN PARAMETER TESTING
727L/min727727L/min1
25TOB09PTVAPE-Z2725
PDUCRCOFPDU Current Cut-off
DESIGN PARAMETER TESTING
34.8mA34.834.8mA1
26TOB09PTVAPE-Z2726
INHAERTInhaled Aerosol Temperature
DESIGN PARAMETER TESTING
36.9C36.936.9C1
27TOB09PTVAPE-Z2727
VENTLTOTTotal Ventilation
DESIGN PARAMETER TESTING
51%5151%1
28TOB09PTVAPE-Z2728
ELQDVISCE-Liquid ViscosityTest performed at 20 degrees CelsiusDESIGN PARAMETER TESTING
496mPa/s496496mPa/s1
29TOB09PTVAPE-Z2729
ELQDVOLE-liquid Volume
DESIGN PARAMETER TESTING
60.1mL60.160.1mL1
30TOB09PTVAPE-Z2730
PNUMCNCParticle Number Concentration
DESIGN PARAMETER TESTING
511/cm3511511/cm31
31TOB09PTVAPE-Z2731
CTMDDIAMCount Median Diameter
DESIGN PARAMETER TESTING
202nm202202nm1
32TOB09PTVAPE-Z2732
PM2.5Particulate Matter 2.5
DESIGN PARAMETER TESTING
24.4ug/m324.424.4ug/m31
$warningHtml

Example

The following example illustrates the representation of a smokeless tobacco product's (portioned snus) identifiers and descriptors using the TO domain. Note that this example uses TOSCAT to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.

to.xpt

to.xpt

RowSTUDYIDDOMAINSPTOBIDTOSEQTOPARMCDTOPARMTOCATTOSCATTOVALTOVALU
1

TOB17

TOSNUS-771TBPRDCATTobacco Product CategoryNEW PRODUCTPRODUCT IDENTIFIERSmokeless Tobacco Products
2TOB17TOSNUS-772TBPRSCATTobacco Product SubcategoryNEW PRODUCTPRODUCT IDENTIFIERPortioned Snus
3TOB17TOSNUS-773MANUFManufacturerNEW PRODUCTPRODUCT IDENTIFIERJoes Smokeless
4TOB17TOSNUS-774TRADENAMTrade NameNEW PRODUCTPRODUCT IDENTIFIERHappy Dog Snus
5TOB17TOSNUS-775PACKTYPPackage TypeNEW PRODUCTPRODUCT DESCRIPTORPlastic Can with Lid
6TOB17TOSNUS-776PACKQUANPackage QuantityNEW PRODUCTPRODUCT DESCRIPTOR24g
7TOB17TOSNUS-777PRTMASSPortion MassNEW PRODUCTPRODUCT DESCRIPTOR1g
8TOB17TOSNUS-778PORTCONTPortion countNEW PRODUCTPRODUCT DESCRIPTOR24
9TOB17TOSNUS-779PRTLENGPortion lengthNEW PRODUCTPRODUCT DESCRIPTOR30mm
10TOB17TOSNUS-7710PRTWDTHPortion widthNEW PRODUCTPRODUCT DESCRIPTOR10mm
11TOB17TOSNUS-7711PRTTHICKPortion thicknessNEW PRODUCTPRODUCT DESCRIPTOR5mm
12TOB17TOSNUS-7712CHARFLAVCharacterizing FlavorNEW PRODUCTPRODUCT DESCRIPTORFlavored
$warningHtml

The manufacturing parameter specifications of the portioned snus tobacco product as intended for use are represented in the PD domain. The following example shows the target, minimum, and maximum values associated with each of 10 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally. 

pd.xpt

pd.xpt

RowSTUDYIDDOMAINSPTOBIDPDSEQPDPARMCDPDPARMPDVALTRGPDVALMINPDVALMAXPDVALU
1

TOB17

PDSNUS-77

1

TOCUTSIZTobacco Cut Size

70

65

75

cuts/in

2

TOB17

PDSNUS-77

1

TOPRTSIZTobacco Particle Size

70

65

75

mm

3TOB17PDSNUS-772TOMOISTRTobacco Moisture32.23134%
4TOB17PDSNUS-773PRTLENGPortion Length3836.539.5mm
5TOB17PDSNUS-774PRTWDTHPortion Width161517mm
6TOB17PDSNUS-775PRTMASSPortion Mass10009001100mg
7TOB17PDSNUS-776PRTTHICKPortion Material Thickness0.060.0550.065mm
8TOB17PDSNUS-777PRTMWGTPouch Material Basis Weight161517g/m2
9TOB17PDSNUS-778PRTMPORPouch Material Porosity185016002200L/m2/s
10TOB17PDSNUS-779NICTDSRTNicotine Dissolution Rate15522%/min
$warningHtml

Finally, the PT domain is used to represent the actual results of testing the manufactured portioned snus product for conformance to the tobacco product design parameters shown in PD. PTCAT is a Required variable and is set to "DESIGN PARAMETER TESTING" for all records here. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only 1 replicate per parameter is shown. Note that PTREPNUM (repetition number) = 1 for all rows.

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDPTSEQPTTESTCDPTTESTPTCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTREPNUM
1TOB17PTSNUS-771TOCUTSIZTobacco Cut SizeDESIGN PARAMETER TESTING

70

cuts per inch

70

70

cuts/in1
2TOB17PTSNUS-771TOPRTSIZTobacco Particle SizeDESIGN PARAMETER TESTING

70

mm

70

70

mm1
3TOB17PTSNUS-772TOMOISTRTobacco MoistureDESIGN PARAMETER TESTING31.8%31.831.8%1
4TOB17PTSNUS-773PRTMASSPortion MassDESIGN PARAMETER TESTING998mg998998mg1
5TOB17PTSNUS-774PRTMWGTPouch Material Basis WeightDESIGN PARAMETER TESTING15.3g/m215.315.3g/m21
6TOB17PTSNUS-775PRTMPORPouch Material PorosityDESIGN PARAMETER TESTING1900L/m2/s19001900L/m2/s1
7TOB17PTSNUS-776NICTDSRTNicotine Dissolution RateDESIGN PARAMETER TESTING18%/min1818%/min1
$warningHtml

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