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  • The smoking regimen is carried out by the smoking machine/device shown in SPDEVID (sponsor-defined device identifier).
  • The storage condition is represented in STOCONID (Storage condition identifier- this variable as created after consultation with our internal standards modeling team).
  • The smoking regimen is represented in PTREFID (we made up a value; we can update with something realistic)
  • We got buy-in on using a new variable, "PTMATRIX" (for the sample matrix), since the existing SDTM "specimen type" variable was not appropriate.


https://www.ecigstats.org/docs/research/CoA_1R6F.pdf - This is a sample Smoking Regime that was used as the basis of the example.


https://open.canada.ca/data/en/dataset/71394df3-aee8-4117-92cb-a035360972a2/resource/7e6b0457-051e-4620-befc-8e4f50b75345 

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This example only shows test results for each constituent for one sample of one product that was tested. The sampling plan and testing plan including the number of samples of the products tested are determined by the sponsor. In reality, sponsors would have multiple product samples tested and those would be distinguished in the dataset. These sample identification information may be represented in PTREFID, and/ or PTSPID. In this example, SPTOBID indicated the product identification, and each sample of that product was numbered as Sample 1 thru Sample n. Many sponsor may use more specific codes to identify the source of product sample.           

Dataset wrap
Namept
Rowcaps
Rows 1-15:Show the HPHC testing performed on one sample of the product with SPTOBID CIG01a. The test condition are represented in PTTSTCND. 
Row 16:Shows the  HPHC testing performed on one sample for one ingredient using the CANDIAN INTENSE test conditions. 
Dataset2
RowSTUDYID
DOMAIN
SPTOBIDSPDEVIDSTOCONIDPTSEQPTREFIDPTCASPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTMETHODPTREPNUMPTTPTPTTPTNUMPTDTC
1Row
STUDYID
DOMAINSPTOBIDPTSEQPTREFIDPTCSREFIDPTTESTCDAnalytePTTSTDTLPTCATHPHC vs other constituentsPTORRESUnitResultPTSTRESNPTSTRESUMethodSmoking RegimeLabLimit of QuantitationPTREPNUMPTDTC
2









PTTEST

PTSCAT
PTORRESUPTSTRESC


PTMETHOD PTNAMPTLLOQ

MATRIX
31
TOB07
PTCIG01a1Batch 10175-07-0ACETALDAcetaldehydeQUANTITYHPHC TESTINGHPHC522µg/cigarette

µg/cigaretteTL001ISO METHODTOBACCO LAB 1
12022-09-30SMOKE
42
TOB07
PTCIG01a2Batch 101107-02-8ACROLAcroleinQUANTITYHPHC TESTINGHPHC43µg/cigarette

µg/cigaretteTL002ISO METHODTOBACCO LAB 1
12022-09-30SMOKE
53
TOB07
PTCIG01a3Batch 101107-13-1ACRLONIAcrylonitrileQUANTITYHPHC TESTINGHPHC7µg/cigarette

µg/cigaretteTL006ISO METHODTOBACCO LAB 1
12022-09-30SMOKE
64
TOB07
PTCIG01a4Batch 10192-67-1AMNPHEN44-AminobiphenylQUANTITYHPHC TESTINGHPHC1.2ng/cigarette

ng/cigarette
ISO METHODTOBACCO LAB 1
12022-09-30SMOKE
75
TOB07
PTCIG01a5Batch 101134-32-7AMNPHTH11-AminonaphthaleneQUANTITYHPHC TESTINGHPHC14ng/cigarette

ng/cigarette
ISO METHODTOBACCO LAB 1
12022-09-30SMOKE
8

TOB07
PTCIG01a6Batch 101134-32-7AMNPHTH22-AminonaphthaleneQUANTITYHPHC TESTINGHPHC8ng/cigarette

ng/cigarette
ISO METHODTOBACCO LAB 1   12022-09-30SMOKE
96
TOB07
PTCIG01a7Batch 1017664-41-7NH4AmmoniaQUANTITYHPHC TESTINGHPHC9µg/cigarette

µg/cigarette
ISO METHODTOBACCO LAB 1
12022-09-30SMOKE
107
TOB07
PTCIG01a8Batch 10171-43-2BENZBenzeneQUANTITYHPHC TESTINGHPHC33µg/cigarette

µg/cigarette
ISO METHODTOBACCO LAB 1
12022-09-30SMOKE
118
TOB07
PTCIG01a9Batch 10150-32-8BENZAPBenzo[a]pyreneQUANTITYHPHC TESTINGHPHC6.8ng/cigarette

ng/cigarette
ISO METHODTOBACCO LAB 1
12022-09-30SMOKE
129
TOB07
PTCIG01a10Batch 101630-08-0COCarbon monoxideQUANTITYHPHC TESTINGHPHC10.1mg/cigarette

mg/cigarette
ISO METHODTOBACCO LAB 1
12022-09-30SMOKE
1310
TOB07
PTCIG01a11Batch 1014170-30-3CROTALDCrotonaldehydeQUANTITYHPHC TESTINGHPHC11µg/cigarette

µg/cigarette
ISO METHODTOBACCO LAB 1
12022-09-30SMOKE
1411
TOB07
PTCIG01a12Batch 10150-00-0FORMALDFormaldehydeQUANTITYHPHC TESTINGHPHC27µg/cigarette

µg/cigarette
ISO METHODTOBACCO LAB 1
12022-09-30SMOKE
1512
TOB07
PTCIG01a13Batch 10178-79-5ISOPRNIsopreneQUANTITYHPHC TESTINGHPHC320µg/cigarette

µg/cigarette
ISO METHODTOBACCO LAB 1
12022-09-30SMOKE
1613
TOB07
PTCIG01a14Batch 1011954-11-05NICNicotineQUANITYHPHC TESTINGHPHC0.721mg/cigarette

mg/cigarette
ISO METHODTOBACCO LAB 1
12022-09-30SMOKE
1714
TOB07
PTCIG01a15Batch 10164091-91-4NNK4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanoneQUANTITYHPHC TESTINGHPHC71ng/cigarette

ng/cigarette
ISO METHODTOBACCO LAB 1
12022-09-30SMOKE
1815
TOB07
PTCIG01a16Batch 10116543-55-8NNNN-nitrosonornicotineQUANTITYHPHC TESTINGHPHC85ng/cigarette

ng/cigarette
ISO METHODTOBACCO LAB 1
12022-09-30SMOKE
19

TOB07
PTCIG01a17Batch 101108-88-3
TolueneQUANTITYHPHC TESTINGHPHC53µg/cigarette

µg/cigarette
ISO METHODTOBACCO LAB 1
12022-09-30SMOKE
2016
TOB07
PTCIG01a18Batch 10175-07-0ACETALDAcetaldehydeQUANTITYHPHC TESTINGHPHC1552µg/cigarette

µg/cigarette
CANADIAN INTENSE METHODTOBACCO LAB 1
12022-09-30SMOKE
2117
TOB07
PTCIG01a19Batch 1017664-41-7AMMONIAAmmoniaQuantityHPHC TESTINGHPHC956µg/g
612µg/cigarette
-

12022-09-30FILLER


the old example - from the original HPHC (as opposed to the one with the device and smoking regimen)

Dataset wrap
Namept
Rowcaps
Rows 1-15:Show the HPHC testing performed on one sample of the product with SPTOBID CIG01a. The test condition are represented in PTTSTCND. 
Row 16:Shows the  HPHC testing performed on one sample for one ingredient using the CANDIAN INTENSE test conditions. 
Dataset2
RowSTUDYIDDOMAINSPTOBIDSPDEVIDSTOCONIDPTSEQPTREFIDPTCASPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTMETHODPTREPNUMPTTPTPTTPTNUMPTDTC
1TOB07PTCIG01a


E-Liquid Standard (Long Term) Condition

1


75-07-0

1

Sample 1ACETALD

Acetaldehyde

HPHC TESTING

HPHC1639ug/cigarette16391639ug/cigaretteSMOKEISO INTENSE METHOD1Week 012022-09-30
2TOB07PTCIG01a2
E-Liquid Standard (Long Term) Condition2
107-02-8Sample 1ACROLAcroleinHPHC TESTINGHPHC154ug/cigarette154154ug/cigarette
ISO INTENSE METHOD1

2022-09-30
3TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition3
Sample 107-13-1ACRLONIAcrylonitrile

HPHC TESTING

HPHC





ISO INTENSE METHOD1

2022-09-30
4TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition4
Sample 92-67-1AMNPHEN44-AminobiphenylHPHC TESTINGHPHC





ISO INTENSE METHOD1

2022-09-30
5TOB07PTCIG01a5
E-Liquid Standard (Long Term) Condition5
134-32-7Sample 1AMNPHTH11-Aminonaphthalene

HPHC TESTING

HPHC





ISO INTENSE METHOD1

2022-09-30
6TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition6Sample 1

7664-41-7

NH4AmmoniaHPHC TESTINGHPHC29.2ug/cigarette29.229.2ug/cigarette
ISO INTENSE METHOD1

2022-09-30
7TOB07PTCIG01a7
E-Liquid Standard (Long Term) Condition7
71-43-2Sample 1BENZBenzene

HPHC TESTING

HPHC





ISO INTENSE METHOD1

2022-09-30
8TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition8Sample 1
50-32-8BENZAPBenzo[a]pyreneHPHC TESTINGHPHC30.5ug/cigarette30.530.5ug/cigarette
ISO INTENSE METHOD1

2022-09-30
9TOB07PTCIG01a9
E-Liquid Standard (Long Term) Condition9
630-08-0Sample 1COCarbon monoxide

HPHC TESTING

HPHC28.2ug/cigarette28.228.2ug/cigarette
ISO INTENSE METHOD1

2022-09-30
10TOB07PTCIG01a10
E-Liquid Standard (Long Term) Condition10
4170-30-3Sample 1CROTALDCrotonaldehydeHPHC TESTINGHPHC0.01
0.010.01

ISO INTENSE METHOD1

2022-09-30
11TOB07PTCIG01a11
E-Liquid Standard (Long Term) Condition11
50-00-0Sample 1FORMALDFormaldehyde

HPHC TESTING

HPHC83.2ug/cigarette83.283.2ug/cigarette
ISO INTENSE METHOD1

2022-09-30
12TOB07PTCIG01a
E-Liquid Standard (Long Term) Condition12Sample 1
78-79-5ISOPRNIsopreneHPHC TESTINGHPHC





ISO INTENSE METHOD1

2022-09-30
13TOB07PTCIG01aPUFFMASTER3KE-Liquid Standard (Long Term) Condition13Sample 1Medium Intensity Regimen1954-11-05NICNicotine

HPHC TESTING

HPHC1.71ug/cigarette1.711.71ug/cigarette
ISO INTENSE METHOD1

2022-09-30
14TOB07PTCIG01aPUFFMASTER3KE-Liquid Standard (Long Term) Condition14Sample 1Medium Intensity Regimen64091-91-4NNK

Nicotine-derived Nitrosamine Ketone

HPHC TESTINGHPHC





ISO INTENSE METHOD1

2022-09-30
15TOB07PTCIG01aPUFFMASTER3KE-Liquid Standard (Long Term) Condition15Sample 1Medium Intensity Regimen

16543-55-8

NNNN-nitrosonornicotine

HPHC TESTING

HPHC284ug/cigarette284284ug/cigarette
ISO INTENSE METHOD1

2022-09-30
16TOB07PTCIG01a

16


E-Liquid Standard (Long Term) Condition

16


75-07-0

Sample 1

ACETALD

Acetaldehyde

HPHC TESTING

HPHC1569ug/cigarette15691569ug/cigarette
CANADIAN INTENSE METHOD1

2022-09-30

The Environmental Storage Conditions (ES) dataset can be used to provide additional details on any test conditions or methods used to perform the testing.   

Dataset wrap
NameES
Big
Dataset2
RowSTUDYIDDOMAINSTOCONIDESSEQESPARMCDESPARMESVALESVALU
1

TOB07

ESCondition 11ISOSTNUMISO Standard NumberISO 33082

TOB07

ESCondition 12PUFFVOLPuff DurationPT2S
3

TOB07

ESCondition 13PUFFVOLPuff Volume35mg
4

TOB07

ESCondition 21PUFFDURPuff DurationPT2S5

TOB07

ESCondition 22SMOKMACSmoking Machine

Next ,we use DU (device-in use properties/settings) for smoking regimen. Note that the separate DI (device identifiers) dataset is needed to show identifying parameters of the "PUFFMASTER3K" smoking machine. We cannot have DU without also including DI).

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