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PTCAS variable (in place of the LBLOINC variable) provides the accurate chemical name, structure for organic and inorganic substances.


Info

Question: For laboratory's limit of detection (LOD), limit of quantification (LOQ); Should we have --ORNRLO = Reference Range Lower Limit in Orig Unit; and --ORNRHI = Reference Range Upper Limit in Orig Unit?  There is a variable --LLOD = Lower Limit of Detection. Added this for LOD. What should be used for LOQ? Thanks.

Dataset wrap
Namept
Rowcaps
Rows 1-20:Show several analytes (as noted in the PTTEST) in the E-Liquid substance for the condition noted in PTTSTCND which is Condition 1. 
Rows 2, 12, 13:Show the
Dataset wrap
Namept
Rowcaps
Rows 1-20:Show several analytes (as noted in the PTTEST) in the E-Liquid substance for the condition noted in PTTSTCND which is Condition 1. 
Rows 2, 12, 13:Show the 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 17, 18:Show microbials, TAMC and TYMC (PTTEST and PTTESTCD), used in testing (aerobic plate count, mold, and yeast) using the PTSCAT variable. The E-Liquid substance has the condition represented using the PTTSTCND which is Condition 1.  E-Liquid substance has the condition represented using the PTTSTCND which is Condition 1.  
1
Dataset2
RowSTUDYIDDOMAINSPTOBIDSPDEVIDSTOCONDIDPTSEQPTREFIDPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTSPECPTSPCCNDPTMETHODPTLLOQPTREPNUMPTTPTPTTPTNUM
1TOB07PT111
Condition 1

1

VAP77777.1NICOTINENicotineSTABILITY STUDY
35.94mg/g
35.9435.94mg/gE-LIQUID


1Week 01
2TOB07PT111
Condition 12VAP77777.1NICOTINENicotineSTABILITY STUDY

0.1039

mg/PUFF
0.10390.1039mg/PUFFAEROSOL


1Week 01
3TOB07PT111
Condition 13VAP77777.1NORNCTN

Nornicotine

STABILITY STUDYNicotine Degradant25.76ug/g
25.7625.76ug/gE-LIQUID


1Week 01
4TOB07PT111
Condition 13VAP77777.1NORNCTN

Nornicotine

STABILITY STUDYNicotine Degradant0.0392ug/PUFF
0.03920.0392ug/PUFFAEROSOL


1Week 01
5TOB07PT111
Condition 15VAP77777.1GLYCRLGlycerolSTABILITY STUDYPrimary Ingredient615.68mg/g
615.68615.68mg/gE-LIQUID


1Week 01
6TOB07PT111
Condition 15VAP77777.1GLYCRLGlycerolSTABILITY STUDYPrimary Ingredient1.81mg/PUFF0.001441.811.81mg/PUFFAEROSOL


1Week 01
7TOB07PT111
Condition 16VAP77777.1PRPYLGLYPropylene GlycolSTABILITY STUDYPrimary Ingredient218.21mg/g
218.21218.21mg/gE-LIQUID


1Week 01
8TOB07PT111
Condition 16VAP77777.1PRPYLGLYPropylene GlycolSTABILITY STUDYPrimary Ingredient0.8565mg/PUFF0.000240.85650.8565mg/PUFFAEROSOL


1Week 01
9TOB07PT111
Condition 17VAP77777.1BNZOICACBenzoic AcidSTABILITY STUDYAcid





E-LIQUID


1Week 01
10TOB07PT111
Condition 18VAP77777.1MENTHOLMentholSTABILITY STUDYFlavorant37.53mg/g
37.5337.53mg/gE-LIQUID


1Week 01
11TOB07PT111
Condition 18VAP77777.1MENTHOLMentholSTABILITY STUDYFlavorant0.5881mg/PUFF0.000240.58810.5881mg/PUFF

AEROSOL




1Week 01
12
Dataset2
RowSTUDYIDDOMAINSPTOBIDSPDEVIDSTOCONDIDPTSEQPTREFIDPTCASPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTSPCCNDPTMETHODPTLLOQPTREPNUMPTTPTPTTPTNUM
TOB07PT111
Condition 1

1


VAP77777.1
54-11-5NICOTINE
GLYCDOLGlycidol
Nicotine
STABILITY STUDY
Stabilizer<Limit of Detection (LOD)
0.00011<Limit of detection (LOD)

AEROSOL

E-LIQUID




1Week 01
2
13TOB07PT111
Condition
12VAP77777.154-11-5NICOTINENicotineSTABILITY STUDY
1
VAP77777.1
FormaldehydeSTABILITY STUDY
0.0728ug/PUFF0.005490.07280.0728ug/PUFF

AEROSOL




1Week 01
3
14TOB07PT111
Condition 1
3

VAP77777.1
494-97-3NORNCTN

Nornicotine

STABILITY STUDYNicotine Degradant

AcrolienSTABILITY STUDY
<Limit of Quantification (LOQ)
0.00928Limit of Quantification (LOQ)

AEROSOL

E-LIQUID




1Week 01
4
15TOB07PT111
Condition 1
4

VAP77777.1
494-52-0ANABASN

Anabasine

STABILITY STUDY

Lactic AcidSTABILITY STUDY
40.44ug/g
40.4440.44ug/g
Nicotine Degradant

E-LIQUID




1Week 01
5
16TOB07PT111
Condition 1
5

VAP77777.1
56-81-5GLYCRLGlycerolSTABILITY STUDYPrimary Ingredient

Lactic AcidSTABILITY STUDY
29.71ug/PUFF0.28429.7129.71ug/PUFF

AEROSOL

E-LIQUID




1Week 01
6
17























18TOB07PT111
Condition 1
6
9VAP77777.1
57-55-6PRPYLGLYPropylene Glycol
VANLLNVanillinSTABILITY STUDY
Primary Ingredient
Flavorant





E-LIQUID


1Week 01
7
19TOB07PT111
Condition 1
7
10VAP77777.1
65-85-0BNZOICACBenzoic Acid
NNKNicotine-Derived Nitrosamine KetoneSTABILITY STUDY
Acid
HPHC





E-LIQUID


1Week 01
8
20TOB07PT111
Condition 1
8XXXXXMenthol
11VAP77777.1

89-78-1

confirm this one, there are two - the other is 1490-04-6

NNNN-Nitrosonornicotine
STABILITY STUDY
Flavorant
HPHC





E-LIQUID


1Week 01
9
21TOB07PT111
Condition 1
9
12VAP77777.1
XXXXX
NNKNicotine-Derived Nitrosamine Ketone
Vanillin
STABILITY STUDY
Flavorant
HPHC
E-LIQUID






AEROSOL


1Week 01
10
22TOB07PT111
Condition 1
10
13VAP77777.1
64091-91-4NNK
NNNN-Nitrosonornicotine
Nicotine-Derived Nitrosamine Ketone
STABILITY STUDYHPHC
E-LIQUID






AEROSOL


1Week 01
11
23TOB07PT111
Condition 1
11
14VAP77777.1
80508-23-2NNNN-Nitrosonornicotine
NICKELNickelSTABILITY STUDY
HPHC
Extractables / Leachables 





E-LIQUID


1Week 01
12
24TOB07PT111
Condition 1
12
14VAP77777.1
64091-91-4NNKNicotine-Derived Nitrosamine KetoneSTABILITY STUDY
MASSMassSTABILITY STUDY
3.87mg/PUFF0.00713.873.87mg/PUFF
HPHC
AEROSOL


1Week 01
13
25TOB07PT111
Condition 1
13
14VAP77777.1
80508-23-2NNNN-Nitrosonornicotine
CHROMIUMChromiumSTABILITY STUDY
HPHC

NOT DETECTED

NOT DETECTED

E-LIQUID
AEROSOL



1Week 01
14
26TOB07PT111
Condition 1
14
15VAP77777.1
NICKEL
PH
Nickel
pHSTABILITY STUDY
Extractables / Leachables 







E-LIQUID


1Week 01
15
27TOB07PT111
Condition 115VAP77777.1PHpHSTABILITY STUDY
E-LIQUID







AEROSOL


1Week 01
16
28TOB07PT111
Condition 116VAP77777.1
XXXXX
ENDTXNEndotoxinSTABILITY STUDYToxins





E-LIQUID


1Week 01
17
29TOB07PT111
Condition 117VAP77777.1AEBPLCTAerobic Plate CountSTABILITY STUDYMicrobiological<1 CFU/mL
<1 <1 CFU/mLE-LIQUID


1Week 01
18
30TOB07PT111
Condition 118VAP77777.1TYMCTotal Yeast and/or Mold CountSTABILITY STUDYMicrobiological1CFU/mL
11CFU/mLE-LIQUID


1Week 01
19
31TOB07PT111
Condition 119VAP77777.1
75-07-0
ACTALDAcetaldehydeSTABILITY STUDYAldehyde





E-LIQUID


1Week 01
20
32TOB07PT111
Condition 120VAP77777.1ACTPROPNAcetyl PropionylSTABILITY STUDYDiketone





E-LIQUID


1Week 01

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.

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