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The document contains sample information for two analyses conducted by Cephas Life Sciences Pvt. Ltd. on a product called Theruptor Sterile Barrier Wound Dressing. Each analysis includes details such as sample ID, processing dates, and quantitative results for various nitrosamines detected. The results are presented in MS chromatograms and quantitative tables, showing retention times and signal-to-noise ratios for each compound.
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0% found this document useful (0 votes)
32 views2 pages

Img 0001

The document contains sample information for two analyses conducted by Cephas Life Sciences Pvt. Ltd. on a product called Theruptor Sterile Barrier Wound Dressing. Each analysis includes details such as sample ID, processing dates, and quantitative results for various nitrosamines detected. The results are presented in MS chromatograms and quantitative tables, showing retention times and signal-to-noise ratios for each compound.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

27-05-2022 12:02:57

CEPHAS LIFE SCIENCES PVT.LTD


Sample Information
Acquired by : Phani Kumar
DateAcquired | 5/27/2022 8:48,52 AM
SampleName : Theruptor Steril€ Banier Wound Dressing
Sample ID : Diluent Blank
Trat# :l
Vial# :l
Injection Volume :20
Data File : Diluent Blank-002.Icd
Method File SPL-22-035 l_EX_LCMS-N-proc.lcm
Original Method File :SPL-22-0151 EX LCMS-N lcm
Processed by : Phani Kumar
Date Processed : 5/2712022 ll23:05 AM

MS Chromatogram
Diluent Blank-002.1cd

{r 10P00, totlooo>srrooo(+t@7
l.oo I
]t6.3e7
l .i
0.ofr
2.88 ](x10,000)
l2t-7s9

l0l 2000-,-56 0000( -)ir.1

I,i9 l (xlr:)>6 1. 1 000(+) ('5

#H __l

o.oaF T
0 3 4 7 8 I )0
nIn

MS Quantilalive Table

t ID#
I
Name
N-Nitrosomorpholine
Ret. Time fitJz
117. t0>45.0s
Height s/N

I, 2 N-Nitrosopyrrolidine l0l.l0>55.10
l N-Nitrosodimethylamine 75.10>43.00
I N-Nitrosodiethylamine 102 2D56.00
5 N-Nilroso-N-Methvlethlanrine 89.10>61.I0
N-Nilroso-Di-N-Propylamine l3 r. t 0>89.10
7 N-Nitrosopiperidine I15.l0>69. | 0
u N-Nitroso-N-Di-bulylamine t59.10>57.20
Tota 0 (l

*u'r*Orr,*;A,,r- Checked By:

1t1
27-05-2022 12.03:02

CEPHAS LIFB SCIBNCES PVT.LTD


Sample Informalion
Acquired by : Phani Kumar
DateAcquired : 5121 /2022 8:5950 AM
Sample Name : TheruDlor Sterile Barrier Wound Dressins
Sample ID Workihg Standnd Solution-Ol
Tratr+ :l
Vial# :2
InjectionVolume :20
Dala File Working Slandard Solutjon-ooJ tcd
Melhod File : SPL-22-03 51_EX_LCMS-N-proc.lcm
Original Method File : SPL-22-0351 EX LCMS-N.lcm
Processed by : Phani Kumar
Date Processed : 5127n022 llt2306 AJ\.I,

MS Chromatogram
Working Standard Solution-003.1cd

Int€nsity
8.39l(xt00) nS H7 r000>15 0500(+)(71

f., /'E
o.oot,-
3.90 kxlO,O00) l0l 1000>55 1000(+)ia2

75 100D43.0000(+)@3

0.00
2.00 102.200D56.0000(+)@41

--
0.00
2.00 89imo-jr-r004tr)@l

) _l
2.96 (x10,000) 13 l. 1000>89. l 000(+)@6

0.00 F--
3.39 (x10.000) iTtrabaxrLoaF@l
]33.8e6
I
0.00 I
3.20 (x10.000)
13l.96l

o.oaf-- _ 1

0l I 56J 9 t0
min

MS Quantitative Table

ID# Name Ret. Time filz Height SrN


l N-Nitrosomorpholine |.497 I17.10>45 05 14222. 6s9 54.86
2 N-Nitrosopynolidine I 521 101.10>55.10 49950t 32019 67.84
.,] N-Nitrosodimethylamine 1188 75.10>43.00 7',7119 5268 l4t.55
t N-Nitrosodiethylamine 1.517 102.20>56.00 26830 178,1 21.7 t
5 N-Nitroso-N-Methylethlamine 1.5 l8 89 10>61 l0 28t572 22t12 324.8,{
N-Nilroso-Di-N-Propylamine 1 726 l3l.l0>89.10 368228 691 96
1 N-Nitrosopiperidine 1.6t0 ll5.l0>69 l0 4t 5949 27995 l8l l5
8 N-Nilroso-N-Di-bulylamine I 999 r59.t0>57.20 38049r 26698 445 73
Tota 2064133 l4I315

*.,r*dBr,:S{2r)r- Checked By:

1t1

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