SDTM Example.Stability Study for E-Liquid Products

The following example illustrates stability study results for an ENDS tobacco product. Stability study results are represented in the PT domain, with PTCAT = STABILITY STUDY.

The first dataset shows 22 constituents each as a single replicate, at one time point and from one set of storage conditions in order to illustrate the variables and terminology required to construct an SDTM-conformant PT dataset for a stability study. Some constituent names (Values of PTTESTCD/PTTEST) appear multiple times because they are tested separately in 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.

The use of SPDEVID and PTREFID in this example on records where PTSPEC=AEROSOL indicates that a smoking machine (SPDEVID) was used to perform a smoking regimen (PTREFID) to produce the aerosol from the e-liquid product. Smoking machine and smoking regimen data are not shown. For an example illustrating these concepts, see Section 3.1.3.1, Harmful and Potentially Harmful Constituents (HPHCs) and Smoking Regimens.

Rows 1-31:	Show several analytes (as noted in the PTTEST) in the E-Liquid substance for the condition noted in STOCONDID which is Condition 1.
Rows 2, 4, 6, 8, 11, 12, 13, 14, 16, 20, 21, 23, 26:	Show the several analytes such as Nicotine, 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK), and N-nitrosonornicotine analytes in the Aerosol substance represented using the PTSPEC variable.
Rows 28, 29:	Show microbials, TAMC and TYMC (PTTEST and PTTESTCD), used in testing (aerobic plate count, mold, and yeast) using the PTSCAT variable.

pt.xpt

Row	STUDYID	DOMAIN	SPDEVID	SPTOBID	STOCONDID	PTSEQ	PTTESTCD	PTTEST	PTCAT	PTSCAT	PTORRES	PTORRESU	PTLLOD	PTSTRESC	PTSTRESN	PTSTRESU	PTNAM	PTXFN	PTSPEC	PTLLOQ	PTREPNUM	PTTPT	PTTPTNUM
1	TOB07	PT		111	Condition 1	1	NICOTINE	Nicotine	STABILITY STUDY		35.94	mg/g		35.94	35.94	mg/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
2	TOB07	PT	PUFFMASTER3K	111	Condition 1	2	NICOTINE	Nicotine	STABILITY STUDY		0.1039	mg/PUFF		0.1039	0.1039	mg/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
3	TOB07	PT		111	Condition 1	3	NORNCTN	Nornicotine	STABILITY STUDY	Nicotine Degradant	25.76	ug/g		25.76	25.76	ug/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
4	TOB07	PT	PUFFMASTER3K	111	Condition 1	4	NORNCTN	Nornicotine	STABILITY STUDY	Nicotine Degradant	0.0392	ug/PUFF		0.0392	0.0392	ug/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
5	TOB07	PT		111	Condition 1	5	GLYCRL	Glycerol	STABILITY STUDY	Primary Ingredient	615.68	mg/g		615.68	615.68	mg/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
6	TOB07	PT	PUFFMASTER3K	111	Condition 1	6	GLYCRL	Glycerol	STABILITY STUDY	Primary Ingredient	1.81	mg/PUFF	0.00144	1.81	1.81	mg/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
7	TOB07	PT		111	Condition 1	7	PRPYLGLY	Propylene Glycol	STABILITY STUDY	Primary Ingredient	218.21	mg/g		218.21	218.21	mg/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
8	TOB07	PT	PUFFMASTER3K	111	Condition 1	8	PRPYLGLY	Propylene Glycol	STABILITY STUDY	Primary Ingredient	0.8565	mg/PUFF	0.00024	0.8565	0.8565	mg/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
9	TOB07	PT		111	Condition 1	9	BNZOICAC	Benzoic Acid	STABILITY STUDY	Acid	42.2	ug/PUFF		42.2	42.2	ug/PUFF	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
10	TOB07	PT		111	Condition 1	10	MENTHOL	Menthol	STABILITY STUDY	Flavorant	37.53	mg/g		37.53	37.53	mg/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
11	TOB07	PT	PUFFMASTER3K	111	Condition 1	11	MENTHOL	Menthol	STABILITY STUDY	Flavorant	0.5881	mg/PUFF	0.00024	0.5881	0.5881	mg/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
12	TOB07	PT	PUFFMASTER3K	111	Condition 1	12	GLYCDOL	Glycidol	STABILITY STUDY	Stabilizer	NOT DETECTED		0.00011	NOT DETECTED			TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
13	TOB07	PT	PUFFMASTER3K	111	Condition 1	13	FRMLDHD	Formaldehyde	STABILITY STUDY		0.0728	ug/PUFF	0.00549	0.0728	0.0728	ug/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
14	TOB07	PT	PUFFMASTER3K	111	Condition 1	14	ACROLN	Acrolien	STABILITY STUDY		DETECTED, BELOW LLOQ		0.00928	DETECTED, BELOW LLOQ			TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
15	TOB07	PT		111	Condition 1	15	LACTICAC	Lactic Acid	STABILITY STUDY		40.44	ug/g		40.44	40.44	ug/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
16	TOB07	PT	PUFFMASTER3K	111	Condition 1	16	LACTICAC	Lactic Acid	STABILITY STUDY		29.71	ug/PUFF	0.284	29.71	29.71	ug/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
17	TOB07	PT		111	Condition 1	17	VANLLN	Vanillin	STABILITY STUDY	Flavorant	1.12	ug/g		1.12	1.12	ug/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
18	TOB07	PT		111	Condition 1	18	NNK	Nicotine-Derived Nitrosamine Ketone	STABILITY STUDY	HPHC	0.0711	ug/g		0.0711	0.0711	ug/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
19	TOB07	PT		111	Condition 1	19	NNN	N-Nitrosonornicotine	STABILITY STUDY	HPHC	0.0852	ug/g		0.0852	0.0852	ug/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
20	TOB07	PT	PUFFMASTER3K	111	Condition 1	20	NNK	Nicotine-Derived Nitrosamine Ketone	STABILITY STUDY	HPHC	0.0577	ug/PUFF		0.0577	0.0577	ug/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
21	TOB07	PT	PUFFMASTER3K	111	Condition 1	21	NNN	N-Nitrosonornicotine	STABILITY STUDY	HPHC	0.0742	ug/PUFF		0.0742	0.0742	ug/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
22	TOB07	PT		111	Condition 1	22	NICKEL	Nickel	STABILITY STUDY	Extractables / Leachables	0.0897	ug/g		0.0897	0.0897	ug/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
23	TOB07	PT	PUFFMASTER3K	111	Condition 1	23	MASS	Mass	STABILITY STUDY		3.87	mg/PUFF	0.0071	3.87	3.87	mg/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
24	TOB07	PT		111	Condition 1	24	CHROMIUM	Chromium	STABILITY STUDY		NOT DETECTED			NOT DETECTED			TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
25	TOB07	PT		111	Condition 1	25	PH	pH	STABILITY STUDY		7.15			7.15	7.15		TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
26	TOB07	PT	PUFFMASTER3K	111	Condition 1	26	PH	pH	STABILITY STUDY		7.24			7.24	7.24		TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
27	TOB07	PT		111	Condition 1	27	ENDTXN	Endotoxin	STABILITY STUDY	Toxins	NOT DETECTED			NOT DETECTED			TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
28	TOB07	PT		111	Condition 1	28	AEBPLCT	Aerobic Plate Count	STABILITY STUDY	Microbiological	<1	CFU/mL		<1		CFU/mL	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
29	TOB07	PT		111	Condition 1	29	TYMC	Total Yeast and/or Mold Count	STABILITY STUDY	Microbiological	1	CFU/mL		1	1	CFU/mL	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
30	TOB07	PT		111	Condition 1	30	ACTALD	Acetaldehyde	STABILITY STUDY	Aldehyde	7.8	ug/mL		7.8	7.8	ug/mL	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
31	TOB07	PT		111	Condition 1	31	ACTPROPN	Acetyl Propionyl	STABILITY STUDY	Diketone	32.4	ug/mL		32.4	32.4	ug/mL	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

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. This is an example, this provides possible tests that might be used to demonstrate how to use the datasets and variables to show what was done for the shelf-life stability study. It shows what timepoint and what type of data follows. It is important to show different test conditions for each analyte. For aerosol a machine similutaion is use so mg/puff is valid.

Rows 1-9:	Show the PTTEST of Nicotine for Condition 1 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 10-19:	Show the PTTEST of Nicotine for Condition 2 across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain.
Rows 20-27:	Show the PTTEST of Nicotine for Condition 3 across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain.

pt.xpt

Row	STUDYID	DOMAIN	SPTOBID	STOCONID	PTSEQ	PTTESTCD	PTTEST	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTNAM	PTXFN	PTSPEC	PTREPNUM	PTTPT	PTTPTNUM
1	TOB07	PT	111	Condition 1	211	NICOTINE	Nicotine	35.94	mg/g	35.94	35.94	mg/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	1	Week 0	1
2	TOB07	PT	111	Condition 1	212	NICOTINE	Nicotine	35.46	mg/g	35.46	35.46	mg/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	2	Week 0	1
3	TOB07	PT	111	Condition 1	213	NICOTINE	Nicotine	35.97	mg/g	35.97	35.97	mg/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	3	Week 0	1
4	TOB07	PT	111	Condition 1	214	NICOTINE	Nicotine	35.55	mg/g	35.55	35.55	mg/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	1	Week 24	4
5	TOB07	PT	111	Condition 1	215	NICOTINE	Nicotine	35.88	mg/g	35.88	35.88	mg/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	2	Week 24	4
6	TOB07	PT	111	Condition 1	216	NICOTINE	Nicotine	35.67	mg/g	35.67	35.67	mg/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	3	Week 24	4
7	TOB07	PT	111	Condition 1	217	NICOTINE	Nicotine	36.11	mg/g	36.11	36.11	mg/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	1	Week 52	9
8	TOB07	PT	111	Condition 1	218	NICOTINE	Nicotine	35.72	mg/g	35.72	35.72	mg/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	2	Week 52	9
9	TOB07	PT	111	Condition 1	219	NICOTINE	Nicotine	35.54	mg/g	35.54	35.54	mg/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	3	Week 52	9
10	TOB07	PT	111	Condition 2	220	NICOTINE	Nicotine	0.1039	mg/PUFF	0.1039	0.1039	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	1	Week 0	1
11	TOB07	PT	111	Condition 2	221	NICOTINE	Nicotine	0.1142	mg/PUFF	0.1142	0.1142	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	2	Week 0	1
12	TOB07	PT	111	Condition 2	222	NICOTINE	Nicotine	0.1282	mg/PUFF	0.1282	0.1282	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	3	Week 0	1
13	TOB07	PT	111	Condition 2	223	NICOTINE	Nicotine	0.1242	mg/PUFF	0.1242	0.1242	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	1	Week 24	4
14	TOB07	PT	111	Condition 2	224	NICOTINE	Nicotine	0.1084	mg/PUFF	0.1084	0.1084	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	2	Week 24	4
15	TOB07	PT	111	Condition 2	225	NICOTINE	Nicotine	0.1174	mg/PUFF	0.1174	0.1174	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	3	Week 24	4
16	TOB07	PT	111	Condition 2	226	NICOTINE	Nicotine	0.1374	mg/PUFF	0.1374	0.1374	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	1	Week 52	9
17	TOB07	PT	111	Condition 2	227	NICOTINE	Nicotine	0.1364	mg/PUFF	0.1364	0.1364	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	2	Week 52	9
18	TOB07	PT	111	Condition 2	228	NICOTINE	Nicotine	0.1264	mg/PUFF	0.1264	0.1264	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	3	Week 52	9
19	TOB07	PT	111	Condition 2	229	NICOTINE	Nicotine	0.1256	mg/PUFF	0.1256	0.1256	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	1	Week 0	1
20	TOB07	PT	111	Condition 3	230	NICOTINE	Nicotine	0.1236	mg/PUFF	0.1236	0.1236	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	2	Week 0	1
21	TOB07	PT	111	Condition 3	231	NICOTINE	Nicotine	0.1126	mg/PUFF	0.1126	0.1126	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	3	Week 0	1
22	TOB07	PT	111	Condition 3	232	NICOTINE	Nicotine	0.1334	mg/PUFF	0.1334	0.1334	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	1	Week 24	4
23	TOB07	PT	111	Condition 3	233	NICOTINE	Nicotine	0.1134	mg/PUFF	0.1134	0.1134	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	2	Week 24	4
24	TOB07	PT	111	Condition 3	234	NICOTINE	Nicotine	0.1125	mg/PUFF	0.1125	0.1125	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	3	Week 24	4
25	TOB07	PT	111	Condition 3	235	NICOTINE	Nicotine	0.1156	mg/PUFF	0.1156	0.1156	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	1	Week 52	9
26	TOB07	PT	111	Condition 3	236	NICOTINE	Nicotine	0.1145	mg/PUFF	0.1145	0.1145	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	2	Week 52	9
27	TOB07	PT	111	Condition 3	237	NICOTINE	Nicotine	0.1157	mg/PUFF	0.1157	0.1157	mg/puff	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	3	Week 52	9

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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. Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU.

es.xpt

Row	STUDYID	DOMAIN	STOCONID	ESSEQ	ESPARMCD	ESPARM	ESVAL	ESVALU
1	TOB07	ES	Condition 1	1	HUMID	Humidity	37	%
2	TOB07	ES	Condition 1	2	TEMP	Temperature	24	C
3	TOB07	ES	Condition 2	1	HUMID	Humidity	60	%
4	TOB07	ES	Condition 2	2	TEMP	Temperature	27	C
5	TOB07	ES	Condition 3	1	HUMID	Humidity	95	%
6	TOB07	ES	Condition 3	2	TEMP	Temperature	31	C

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SDTM Example.Stability Study for E-Liquid Products