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The following example illustrates stability study results for an ENDS tobacco product. Stability study results are represented in the Tobacco Product Testing (PT) domain, with PTCAT = STABILITY STUDYTESTING.

Info

The first pt.xpt dataset shows 22 constituents consituents and parameters each as a single replicate (PTREPNUM=1), at one 1 time point (PTTPT=Week 0 / PTTPTNUM=1) and from one 1 set of storage conditions (STOCONID= Condition 1) in order to illustrate the variables and terminology required to construct an SDTM-conformant PT dataset for a stability study. Some constituent names (Values values of PTTESTCD/PTTEST) appear twice because they are tested separately in both e-liquid and aerosol (as indicated by PTSPEC). Note that the constituent names shown do not represent an exhaustive list of the controlled terminology that will be developed to support representation of stability studies in SDTM.

Note
  • The use of SPDEVID and PTREFID in this example on records where PTSPEC=AEROSOL indicates that a smoking machine (shown in SPDEVID) was used to perform the smoking vaping regimen (shown in PTREFID) to produce the aerosol from the e-liquid product on records where PTSPEC=AEROSOL. Details of the smoking machine and smoking vaping regimen are not shown in this example. For examples illustrating how to represent these concepts in SDTM, see Section 3.1.3.1, Harmful and Potentially Harmful Constituents (HPHCs) and Smoking Regimens.2, HPHCs, Other Constituents, and Smoking / Vaping Regimens.
  • PTXFN (External File Path) is used to document the location or file name within the submission that contains the lab methodology protocol used to assay the associated constituent when such methodology is too complex for the single PTMETHOD variable.
  • STOCONID is used to identify the storage conditions of the e-liquid product for the testing performed. Details STOCONID is used to identify the storage conditions of the e-liquid product for the testing performed. Details of these conditions are represented in the Environmental Storage Conditions (ES) dataset example that follows the two 2 PT dataset examples. 
  • In this example, the applicant chose to sub-categorize some constituents subcategorize some consituents and parameters using the permissible variable PTSCAT (Sub-Category of Test).
Dataset wrap
Namept
Rowcaps
Rows 1, 3, 5, 7, 9, 10, 15, 17-19, 22, 24, 25, 27-31:Show the results of testing for constituents in samples of e-liquid product (PTSPEC=E-LIQUID).
Rows 2, 4, 6, 8, 11-14, 16, 20, 21, 23, 26:Show the results of testing for constituents/parameters in aerosol produced from the e-liquid product. The smoking machine is shown in SPDEVID and the regimen is shown in PTREFID.
Dataset2
RowSTUDYIDDOMAINSPTOBIDSPDEVID
SPTOBID
STOCONDIDPTSEQPTREFIDPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTNAMPTXFNPTSPECPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07PT111
Condition 1

1


NICOTINENicotineSTABILITY
STUDY
TESTING
35.94mg/g
35.9435.94mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
2TOB07PT111PUFFMASTER3K
111
Condition 12NON-INTENSE REGIMENNICOTINENicotineSTABILITY
STUDY
TESTING

0.1039

mg/PUFF
0.10390.1039mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
3TOB07PT111
Condition 13
NORNCTN

Nornicotine

STABILITY
STUDY
TESTINGNicotine Degradant25.76ug/g
25.7625.76ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
4TOB07PT111PUFFMASTER3K
111
Condition 14NON-INTENSE REGIMENNORNCTN

Nornicotine

STABILITY
STUDY
TESTINGNicotine Degradant0.0392ug/PUFF
0.03920.0392ug/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
5TOB07PT111
Condition 15
GLYCRLGlycerolSTABILITY
STUDY
TESTINGPrimary Ingredient615.68mg/g
615.68615.68mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
6TOB07PT111PUFFMASTER3K
111
Condition 16NON-INTENSE REGIMENGLYCRLGlycerolSTABILITY
STUDY
TESTINGPrimary Ingredient1.81mg/PUFF0.001441.811.81mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
7TOB07PT111
Condition 17
PRPYLGLYPropylene GlycolSTABILITY
STUDY
TESTINGPrimary Ingredient218.21mg/g
218.21218.21mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
8TOB07PT111PUFFMASTER3K
111
Condition 18NON-INTENSE REGIMENPRPYLGLYPropylene GlycolSTABILITY
STUDY
TESTINGPrimary Ingredient0.8565mg/PUFF0.000240.85650.8565mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
9TOB07PT111
Condition 19
BNZOICACBenzoic AcidSTABILITY
STUDY
TESTINGAcid42.2ug/PUFF
42.242.2ug/PUFFTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
10TOB07PT111
Condition 110
MENTHOLMentholSTABILITY
STUDY
TESTINGFlavorant37.53mg/g
37.5337.53mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
11TOB07PT111PUFFMASTER3K
111
Condition 111NON-INTENSE REGIMENMENTHOLMentholSTABILITY
STUDY
TESTINGFlavorant0.5881mg/PUFF0.000240.58810.5881mg/PUFFTPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.001102-01-2023Week 01
12TOB07PT111PUFFMASTER3K
111
Condition 112NON-INTENSE REGIMENGLYCDOLGlycidolSTABILITY
STUDY
TESTINGStabilizerNOT DETECTED
0.00011NOT DETECTED

TPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.001102-01-2023Week 01
13TOB07PT111PUFFMASTER3K
111
Condition 113NON-INTENSE REGIMENFRMLDHDFormaldehydeSTABILITY
STUDY
TESTING
0.0728ug/PUFF0.005490.07280.0728ug/PUFFTPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.001102-01-2023Week 01
14TOB07PT111PUFFMASTER3K
111
Condition 114NON-INTENSE REGIMENACROLNAcrolienSTABILITY
STUDY
TESTING
DETECTED, BELOW LLOQ
0.00928DETECTED, BELOW LLOQ

TPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.001102-01-2023Week 01
15TOB07PT111
Condition 115
LACTICACLactic AcidSTABILITY
STUDY
TESTING
40.44ug/g
40.4440.44ug/gTPT LABCOTLEL01_v1.5.pdf

E-LIQUID

0.0011
Week 0
02-01-2023Week 01
16TOB07PT111PUFFMASTER3K
111
Condition 116NON-INTENSE REGIMENLACTICACLactic AcidSTABILITY
STUDY
TESTING
29.71ug/PUFF0.28429.7129.71ug/PUFFTPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.001102-01-2023Week 01
17TOB07PT111
Condition 117
VANLLNVanillinSTABILITY
STUDY
TESTINGFlavorant1.12ug/g
1.121.12ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
18TOB07PT111
Condition 118
NNKNicotine-Derived Nitrosamine KetoneSTABILITY
STUDY
TESTINGHPHC0.0711ug/g
0.07110.0711ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
19TOB07PT111
Condition 119
NNNN-NitrosonornicotineSTABILITY
STUDY
TESTINGHPHC0.0852ug/g
0.08520.0852ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
20TOB07PT111PUFFMASTER3K
111
Condition 120NON-INTENSE REGIMENNNKNicotine-Derived Nitrosamine KetoneSTABILITY
STUDY
TESTINGHPHC0.0577ug/PUFF
0.05770.0577ug/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
21TOB07PT111PUFFMASTER3K
111
Condition 121NON-INTENSE REGIMENNNNN-NitrosonornicotineSTABILITY
STUDY
TESTINGHPHC0.0742ug/PUFF
0.07420.0742ug/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
22TOB07PT111
Condition 122
NICKELNickelSTABILITY
STUDY
TESTINGExtractables / Leachables0.0897ug/g
0.08970.0897ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011
Week
02-01-2023Week 01
23TOB07PT111PUFFMASTER3K
111
Condition 123NON-INTENSE REGIMENMASSMassSTABILITY
STUDY
TESTING
3.87mg/PUFF0.00713.873.87mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
24TOB07PT111
Condition 124
CHROMIUMChromiumSTABILITY
STUDY
TESTING
NOT DETECTED

NOT DETECTED

TPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
25TOB07PT111
Condition 125
PH

pH

STABILITY
STUDY
TESTING
7.15

7.157.15
TPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
26TOB07PT111PUFFMASTER3K
111
Condition 126NON-INTENSE REGIMENPHpHSTABILITY
STUDY
TESTING
7.24

7.247.24
TPT LABCOTLAE01_v2.1.pdfAEROSOL0.001102-01-2023Week 01
27TOB07PT111
Condition 127
ENDTXNEndotoxinSTABILITY
STUDY
TESTINGToxinsNOT DETECTED

NOT DETECTED

TPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
28TOB07PT111
Condition 128
AEBPLCT

AEBCTAerobic
Plate
Colony CountSTABILITY
STUDY
TESTINGMicrobiological<1CFU/mL
<1
CFU/mLTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
29TOB07PT111
Condition 129
TYMC

YSTMLDCT
Total
Yeast and/or Mold Colony CountSTABILITY
STUDY
TESTINGMicrobiological1CFU/mL
11CFU/mLTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
30TOB07PT111
Condition 130
ACTALDAcetaldehydeSTABILITY
STUDY
TESTINGAldehyde7.8ug/mL
7.87.8ug/mLTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
31TOB07PT111
Condition 131
ACTPROPNAcetyl PropionylSTABILITY
STUDY
TESTINGDiketone32.4ug/mL
32.432.4ug/mLTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.001102-01-2023Week 01
Info

The second pt.xpt PT dataset shows testing for just one 1 constituent , (nicotine), performed in three 3 replicates (note the values of PTREPNUM), at three the first 3 time points of the study (as shown in PTTPT/PTTPTNUM), from three 3 sets of storage conditions (STOCONID), in samples of e-liquid and aerosol )(PTSPEC) in order to illustrate how those variables are used to represent their associated concepts in a stability study. 

Note
  • As in the first pt.xpt PT dataset, the details of the smoking machine and smoking vaping regimen are not shown in this example. For examples illustrating how to represent these concepts in SDTM, see Section 3.1.3.1, Harmful and Potentially Harmful Constituents (HPHCs) and Smoking 2, HPHCs, Other Constituents, and Smoking/Vaping Regimens.
  • Details of the three 3 conditions are represented in the ES dataset example that follows below.
Dataset wrap
Namept
Dataset2
Row

STUDYID

DOMAINSPTOBIDSPDEVIDSTOCONIDPTSEQPTREFIDPTTESTCDPTTESTPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTNAMPTXFNPTSPECPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07PT111
Condition 1211
NICOTINE

Nicotine

35.94mg/g35.9435.94mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID102-01-2023Week 01
2TOB07PT111
Condition 1212


NICOTINE

Nicotine35.46mg/g35.4635.46mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID202-01-2023Week 01
3TOB07PT111
Condition 1213
NICOTINENicotine35.97mg/g35.9735.97mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID302-01-2023Week 01
4TOB07PT111
Condition 1214
NICOTINENicotine35.55mg/g35.5535.55mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID1Week 2403-29-2023Week 824
5TOB07PT111
Condition 1215
NICOTINENicotine35.88mg/g35.8835.88mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID203-29-2023Week 24842
6TOB07PT111
Condition 1216
NICOTINENicotine35.67mg/g35.6735.67mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID3Week 2403-29-2023Week 824
7TOB07PT111
Condition 1217
NICOTINENicotine36.11mg/g36.1136.11mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID1Week 5207-19-2023Week 2439
8TOB07PT111
Condition 1218
NICOTINENicotine35.72mg/g35.7235.72mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID207-19-2023Week 522493
9TOB07PT111
Condition 1219
NICOTINENicotine35.54mg/g35.5435.54mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID307-19-2023Week 522493
10TOB07PT111PUFFMASTER3KCondition 2220NON-INTENSE REGIMENNICOTINE

Nicotine

0.1039mg/PUFF0.10390.1039mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL102-01-2023Week 01
11TOB07PT111PUFFMASTER3KCondition 2221NON-INTENSE REGIMENNICOTINENicotine0.1142mg/PUFF0.11420.1142mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL202-01-2023Week 01
12TOB07PT111PUFFMASTER3KCondition 2222NON-INTENSE REGIMENNICOTINENicotine0.1282mg/PUFF0.12820.1282mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL302-01-2023Week 01
13TOB07PT111PUFFMASTER3KCondition 2223NON-INTENSE REGIMENNICOTINENicotine0.1242mg/PUFF0.12420.1242mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 2403-29-2023Week 824
14TOB07PT111PUFFMASTER3KCondition 2224NON-INTENSE REGIMENNICOTINENicotine0.1084mg/PUFF0.10840.1084mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 2403-29-2023Week 824
15TOB07PT111PUFFMASTER3KCondition 2225NON-INTENSE REGIMENNICOTINENicotine0.1174mg/PUFF0.11740.1174mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL303-29-2023Week 24842
16TOB07PT111PUFFMASTER3KCondition 2226NON-INTENSE REGIMENNICOTINENicotine0.1374mg/PUFF0.13740.1374mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL107-19-2023Week 522493
17TOB07PT111PUFFMASTER3KCondition 2227NON-INTENSE REGIMENNICOTINENicotine0.1364mg/PUFF0.13640.1364mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL207-19-2023Week 522493
18TOB07PT111PUFFMASTER3KCondition 2228NON-INTENSE REGIMENNICOTINENicotine0.1264mg/PUFF0.12640.1264mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL307-19-2023Week 522493
19TOB07PT111PUFFMASTER3KCondition 2229NON-INTENSE REGIMENNICOTINENicotine0.1256mg/PUFF0.12560.1256mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL102-01-2023Week 01
20TOB07PT111PUFFMASTER3KCondition 3230NON-INTENSE REGIMENNICOTINENicotine0.1236mg/PUFF0.12360.1236mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2202-01-2023Week 01
21TOB07PT111PUFFMASTER3KCondition 3231NON-INTENSE REGIMENNICOTINENicotine0.1126mg/PUFF0.11260.1126mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL302-01-2023Week 01
22TOB07PT111PUFFMASTER3KCondition 3232NON-INTENSE REGIMENNICOTINENicotine0.1334mg/PUFF0.13340.1334mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 2403-29-2023Week 824
23TOB07PT111PUFFMASTER3KCondition 3233NON-INTENSE REGIMENNICOTINENicotine0.1134mg/PUFF0.11340.1134mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL203-29-2023Week 24842
24TOB07PT111PUFFMASTER3KCondition 3234NON-INTENSE REGIMENNICOTINENicotine0.1125mg/PUFF0.11250.1125mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 2403-29-2023Week 824
25TOB07PT111111PUFFMASTER3KCondition 3235NON-INTENSE REGIMENNICOTINENicotine0.1156mg/PUFF0.11560.1156mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL107-19-2023Week 522493
26TOB07PT111PUFFMASTER3KCondition 3236NON-INTENSE REGIMENNICOTINENicotine0.1145mg/PUFF0.11450.1145mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 5207-19-2023Week 2439
27TOB07PT111PUFFMASTER3KCondition 3237NON-INTENSE REGIMENNICOTINENicotine0.1157mg/PUFF0.11570.1157mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL307-19-2023Week 522493

Details of the storage conditions are represented in the Environmental Storage Conditions ( ES ) dataset. The variable STOCONID/Storage Condition ID represents the storage condition and links to the PT datasets above by matching values of STOCONID there. Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU. The es.xpt ES dataset below shows all three 3 sets of storage conditions used across both pt.xpt of the PT dataset examples above.

Dataset wrap
Namees
Dataset2
RowSTUDYIDDOMAINSTOCONIDESSEQESPARMCDESPARMESVALESVALU
1

TOB07

ESCondition 11HUMIDHumidity37%
2

TOB07

ESCondition 12TEMPTemperature24C
3

TOB07

ESCondition 21HUMIDHumidity60%
4

TOB07

ESCondition 22TEMPTemperature27C
5

TOB07

ESCondition 31HUMIDHumidity95%
6

TOB07

ESCondition 32TEMPTemperature31C