The example below demonstrates the required data structure of one record per analyte per replicate per test condition per timepoint to accurately represent data from a stability study. The resulting structure would require 648 rows to illustrate the 12 analytes shown in the example study we received, done in triplicate under two test conditions at the number of timepoints in the example study.
For conciseness, we have abbreviated the examples below to demonstrate the concepts as follows:
First- we show all 12 analytes as a single replicate, at one time point and one test condition in order to illustrate the variables and terminology required to put together a stability study with assays done in replicate at different time points and varying test conditions, even though only one record per analyte is illustrated.
Second- We show ONE analyte (moisture) in triplicate, over a series of time points and two test conditions to give a sense of what the complete data would look like.
Hopefully users could combine the information shown in both examples to construct a complete dataset containing all the records for each analyte-replicate-test condition-time point group.
Tobacco domains
DI = TO for Tobacco Product Identifiers and Descriptors
SPDEVID = SPTOBID for Sponsor Tobacco Product Identifier
Shelf life study has a protocol and provides the results of shelf life studies of Vapes products over time with different conditions and analytes. Generally there are many conditions with at least two with varying temperature, humidity, etc.
The initial table shows the a number of the analytes and test conditions used in Shelf Life studies for Vapes products for one testing condition at one timepoint and one replicate.
Tobacco Product Testing (TT) is a Findings domain similar to the Laboratory Test Results domain.
Rows 1-12:
Shows several analytes (as noted in the PTTEST) in the E-Liquid substance for the condition noted in PTTSTCND which is E-Liquid Standard (Long Term) Condition.
Row 13:
Show microbials used in testing (aerobic plate count, mold, and yeast) using the PTTEST and PTTESTCD variable in the E-Liquid substance for the condition noted in PTTSTCND which is E-Liquid Standard (Long Term) Condition.
Row Captions Debug Message
Remember to keep number agreement between labels and captions.
pt.xpt
pt.xpt
Row
STUDYID
DOMAIN
PTSEQ
PTREFID
SPTOBID
PTTESTCD
PTTEST
PTCAT
PTSCAT
PTTSTCND
PTORRES
PTORRESU
PTSTRESC
PTSTRESN
PTSTRESU
PTSPEC
PTSPCCND
PTMETHOD
PTLLOQ
PTREPNUM
PTTPT
PTTPTNUM
1
TOB07
PT
1
VAP77777.1
111
NIC
Nicotine
STABILITY STUDY
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
2
TOB07
PT
2
VAP77777.1
111
XXXXX
Nicotine Degredants - add a few
STABILITY STUDY
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
3
TOB07
PT
3
VAP77777.1
111
XXXXX
Glycerin
STABILITY STUDY
Primary Ingredient
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
4
TOB07
PT
3
VAP77777.1
111
XXXXX
Propylene Glycol
STABILITY STUDY
Primary Ingredient
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
5
TOB07
PT
4
VAP77777.1
111
XXXXX
Acids
STABILITY STUDY
Organic compounds
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
6
TOB07
PT
4
VAP77777.1
111
RXN
Reaction Product
STABILITY STUDY
Organic compounds
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
7
TOB07
PT
6
VAP77777.1
111
XXXXX
Flavorant - add Menthol
STABILITY STUDY
Flavorant
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
8
TOB07
PT
6
VAP77777.1
111
XXXXXX
Flavorant
Nicotine salt solution
STABILITY STUDY
Flavorant
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
9
TOB07
PT
8
VAP77777.1
111
XXXXX
HPHC
STABILITY STUDY
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
10
TOB07
PT
10
VAP77777.1
111
XXXXX
Extractables / Leachables
STABILITY STUDY
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
11
TOB07
PT
11
VAP77777.1
111
XXXXX
Non targeted compounds
STABILITY STUDY
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
12
TOB07
PT
12
VAP77777.1
111
XXXXX
Potential Combustion Products
STABILITY STUDY
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
13
TOB07
PT
12
VAP77777.1
111
PH
pH
STABILITY STUDY
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
14
TOB07
PT
12
VAP77777.1
111
XXXXX
microbiological
STABILITY STUDY
E-Liquid Standard (Long Term) Condition
E-LIQUID
1
Week 0
1
Dataset Debug Messages
There are three leading, trailing, or non-breaking spaces in the dataset.
*DWB=Dry weight basis. The DWB normalizes the results since starting moisture may vary.
A Shelf Life study dataset would shows analytes done in different test conditions with replicates over time points. In the interest of brevity for this example, only portions of the content using the TEST of Nicotine is shown in a sample of timepoints in two conditions with replicates. The weeks reflective of Week 1, Week 2, Week 3, etc. which would align with the PTTPTNUM of 2,3, etc. are not shown for visual viewing purposes.
Rows 1-9:
Show the PTTEST of Nicotine for E-Liquid Standard (Long Term) Condition which is shown in PTTSTCND. The sample of various timepoints that may be used in the testing for Nicotine is reflected in PTTPT. The PTTPTNUM shows the numerical version of the planned timepoint. The REPNUM shows the incidence number of a test that is repeated within a given timeframe for the same test.
Rows 10-18:
Show the PTTEST of Nicotine for E-Liquid Accelerated Aging Condition across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain.
Rows 19-28:
Show the PTTEST of Nicotine for E-Vapor Standard Aerosol Condition across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain.
Rows 29-36:
Show the PTTEST of Nicotine for E-Vapor Intense Aerosol Condition across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain.