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Tobacco product stability is assessed to ensure products are as expected with regard to their properties, characteristics and constituents over the course of the product's shelf-life after manufacture. Any changes of a product over time may affect the health risks of product use.

  • Finished product stability studies - most common. This may include aspects of:
    • raw materials stability studies - mention, but not focus
    • bulk e-liquid stability studies - mention,  but not focus


Measures of stability may include:

  • microbial stability
  • chemical stability
  • product component stability (i.e. battery)
  • container closure stability (i.e. leachability)
  • shelf life and storage

Example

The first PT dataset shows 7 constituents/parameters, each as a single replicate (PTREPNUM=1), at 1 time point (PTTPT=Week 0 / PTTPTNUM=1) and from 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 of a smokeless product. Some constituent names (Values of PTTESTCD/PTTEST) appear twice because their results are reported two separate ways: once for the result as tested and once where the result is expressed as dry weight basis (the latter is indicated by PTTSTDTL = DRY WEIGHT BASIS). Note that the constituent/parameter names shown do not represent an exhaustive list of the controlled terminology that will be developed to support representation of stability studies in SDTM.

  • 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 ES dataset example that follows the 2 PT dataset examples. 
  • 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/parameter when such methodology is too complex for the single PTMETHOD variable.

Row 1:

Shows the PTTEST of Moisture Content, which reflects the percentage of moisture in the substance for the condition noted in STOCONID (i.e., Condition 1). Moisture Content is used in chemistry stability studies. For microbial stability studies, Water Activity should be used, not Moisture Content (see row 3).

Rows 4, 6:Show the NNK and NNN tests with the results from the tobacco product as tested.
Rows 5, 7:Show the NNK and NNN test results as dry weight basis (DWB). Note the use of PTTSTDTL = "DRY WEIGHT BASIS"
Rows 2-3, 8-9:

Show the other analytes measured in testing.

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDSTOCONIDPTSEQPTTESTCDPTTESTPTTSTDTLPTCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07PTSmokeless01Condition 11MOISTCTTMoisture Content
STABILITY TESTING52.0%0.152.052.0%

TLT07_V1

TPT LABCOTOBACCO0.12102-01-2023Week 01
2TOB07PTSmokeless01Condition 12PHpH
STABILITY TESTING8.06

8.068.06
TL009_V1TPT LABCOTOBACCO
102-01-2023Week 01
3TOB07PTSmokeless01Condition 13H2OACTWater Activity
STABILITY TESTING0.86
0.010.860.86
TLPH01_V1TPT LABCOTOBACCO0.05102-01-2023Week 01
4TOB07PTSmokeless01Condition 14NNKNicotine-Derived Nitrosamine Ketone
STABILITY TESTING1.0225ug/g0.011.02251.0225ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
5TOB07PTSmokeless01Condition 15NNKNicotine-Derived Nitrosamine KetoneDRY WEIGHT BASISSTABILITY TESTING0.4908ug/g0.010.49080.4908ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
6TOB07PTSmokeless01Condition 16NNNN-Nitrosonornicotine
STABILITY TESTING4.4633ug/g0.014.46334.4633ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
7TOB07PTSmokeless01Condition 17NNNN-NitrosonornicotineDRY WEIGHT BASISSTABILITY TESTING2.1424ug/g0.012.14242.1424ug/gTL026_V12.2TPT LABCOTOBACCO0.05102-01-2023Week 01
8TOB07PTSmokeless01Condition 18AEBCTAerobic Colony Count
STABILITY TESTING154000CFU/g1154000154000CFU/gTLMB_V1.1TPT LABCOTOBACCO1102-01-2023Week 01
9TOB07PTSmokeless01Condition 19YSTMLDCTYeast and/or Mold Colony Count
STABILITY TESTING<10CFU/g1<10
CFU/gTLMB_V1.1TPT LABCOTOBACCO1102-01-2023Week 01
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Dataset Wrapper Debug Message

Please add a row column to your dataset.

The second PT dataset shows testing for just 1 parameter (Moisture Content), performed in 3 replicates (note the values of PTREPNUM), at the first 3 time points of the study (as shown in PTTPT/PTTPTNUM), from 2 sets of storage conditions (STOCONID), in samples of both dried and as-is tobacco (PTSPEC, PTSPCCND) in order to illustrate how those variables are used to represent their associated concepts in a stability study. 

  • Details of the storage conditions are represented in the ES dataset example that follows.

Rows 1-9:

Show the results of testing Moisture Content in 3 replicates (PTREPNUM) at 3 timepoints (weeks 0, 8, and 24) under the storage "Condition 1" (STOCONID).

Rows 10-18:Show the results of testing Moisture Content in 3 replicates (PTREPNUM) at 3 timepoints (weeks 0, 8, and 24) under the storage "Condition 2" (STOCONID).

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDSTOCONIDPTSEQPTTESTCDPTTESTPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTSPCCNDPTLLOQPTREPNUMPTDTCPTTPTPTTPTNUM
1TOB07PTSmokeless01Condition 1111MOISTCTTMoisture Content51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-2023Week 01
2TOB07PTSmokeless01Condition 1112MOISTCTTMoisture Content51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-2023Week 01
3TOB07PTSmokeless01Condition 1113MOISTCTTMoisture Content51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-2023Week 01
4TOB07PTSmokeless01Condition 1114MOISTCTTMoisture Content51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023Week 82
5TOB07PTSmokeless01Condition 1115MOISTCTTMoisture Content51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 82
6TOB07PTSmokeless01Condition 1116MOISTCTTMoisture Content51.67%0.151.6751.67%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023Week 82
7TOB07PTSmokeless01Condition 1117MOISTCTTMoisture Content52.05%0.152.0552.05%TLT07_V1TPT LABCOTOBACCOAS-IS0.12107-19-2023Week 243
8TOB07PTSmokeless01Condition 1118MOISTCTTMoisture Content52.68%0.152.6852.68%TLT07_V1TPT LABCOTOBACCOAS-IS0.12207-19-2023Week 243
9TOB07PTSmokeless01Condition 1119MOISTCTTMoisture Content52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.12307-19-2023Week 243
10TOB07PTSmokeless01Condition 2120MOISTCTTMoisture Content51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.12102-01-2023Week 01
11TOB07PTSmokeless01Condition 2121MOISTCTTMoisture Content51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.12202-01-2023Week 01
12TOB07PTSmokeless01Condition 2122MOISTCTTMoisture Content51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.12302-01-2023Week 01
13TOB07PTSmokeless01Condition 2123MOISTCTTMoisture Content51.80%0.151.8051.80%TLT07_V1TPT LABCOTOBACCOAS-IS0.12103-29-2023Week 82
14TOB07PTSmokeless01Condition 2124MOISTCTTMoisture Content51.77%0.151.7751.77%TLT07_V1TPT LABCOTOBACCOAS-IS0.12203-29-2023Week 82
15TOB07PTSmokeless01Condition 2125MOISTCTTMoisture Content51.84%0.151.8451.84%TLT07_V1TPT LABCOTOBACCOAS-IS0.12303-29-2023Week 82
16TOB07PTSmokeless01Condition 2126MOISTCTTMoisture Content52.18%0.152.1852.18%TLT07_V1TPT LABCOTOBACCOAS-IS0.12107-19-2023Week 243
17TOB07PTSmokeless01Condition 2127MOISTCTTMoisture Content52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.12207-19-2023Week 243
18TOB07PTSmokeless01Condition 2128MOISTCTTMoisture Content51.87%0.151.8751.87%TLT07_V1TPT LABCOTOBACCOAS-IS0.12307-19-2023Week 243
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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 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 dataset shows both sets of storage conditions used across both of the PT dataset examples.

es.xpt

es.xpt

RowSTUDYIDDOMAINSTOCONIDESSEQESPARMCDESPARMESVALESVALU
1

TOB07

ESCondition 11HUMIDHumidity37%
2

TOB07

ESCondition 12TEMPTemperature24C
3

TOB07

ESCondition 21HUMIDHumidity85%
4

TOB07

ESCondition 22TEMPTemperature27C
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Example

The following example illustrates calculation of some of the statistics typically calculated on product stability measures.

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adpt.xpt

RowSTUDYIDPRODSTIDSPTOBIDSTOCONIDPARQUALPARAMPARAMCDAVALATPTATPTN
1TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)AverageAVERAGE51.95667Week 01
2TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)S.D.STD0.025166Week 01
3TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)% RSDPCTRSD0.048437Week 01
4TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)AverageAVERAGE51.72333Week 82
5TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)S.D.STD0.046188Week 82
6TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)% RSDPCTRSD0.089298Week 82
7TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)AverageAVERAGE52.31333Week 243
8TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)S.D.STD0.327465Week 243
9TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)% RSDPCTRSD0.625969Week 243
10TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)AverageAVERAGE51.95667Week 01
11TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)S.D.STD0.025166Week 01
12TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)% RSDPCTRSD0.048437Week 01
13TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)AverageAVERAGE51.80333Week 82
14TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)S.D.STD0.035119Week 82
15TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)% RSDPCTRSD0.067793Week 82
16TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)AverageAVERAGE52.08667Week 243
17TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)S.D.STD0.188237Week 243
18TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)% RSDPCTRSD0.361393Week 243
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ADPT Dataset Metadata

ADPT Variable Metadata



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