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 pt.xpt dataset shows 22 constituents each as a single replicate (PTREPNUM=1), at one time point (PTTPT=Week 0 / PTTPTNUM=1) and from one 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 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.

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 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 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.
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 of these conditions are represented in the ES dataset example that follows the two PT dataset examples.
In this example, the applicant chose to sub-categorize some constituents using the permissible variable PTSCAT (Sub-Category of Test).

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 in aerosol produced from the e-liquid product. The smoking machine is shown in SPDEVID and the regimen is shown in PTREFID.

pt.xpt

Row	STUDYID	DOMAIN	SPDEVID	SPTOBID	STOCONDID	PTSEQ	PTREFID	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	NON-INTENSE REGIMEN	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	NON-INTENSE REGIMEN	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	NON-INTENSE REGIMEN	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	NON-INTENSE REGIMEN	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	NON-INTENSE REGIMEN	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	NON-INTENSE REGIMEN	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	NON-INTENSE REGIMEN	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	NON-INTENSE REGIMEN	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	NON-INTENSE REGIMEN	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	NON-INTENSE REGIMEN	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	NON-INTENSE REGIMEN	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	NON-INTENSE REGIMEN	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	NON-INTENSE REGIMEN	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

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The second pt.xpt dataset shows testing for just one constituent, nicotine, performed in three replicates (note the values of PTREPNUM), at the first three time points of the study (as shown in PTTPT / PTTPTNUM), from three 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.

As in the first pt.xpt dataset, the details of the smoking machine and smoking 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.
Details of the three conditions are represented in the ES dataset example that follows below.

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 8	2
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 8	2
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 8	2
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 24	3
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 24	3
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 24	3
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 8	2
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 8	2
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 8	2
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 24	3
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 24	3
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 24	3
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 8	2
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 8	2
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 8	2
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 24	3
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 24	3
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 24	3

$warningHtml

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 dataset below shows all three sets of storage conditions used across both pt.xpt dataset examples above.

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

$warningHtml

Page tree

SDTM Example.Stability Study for E-Liquid Products