MC-2321 - Moravek, Incproducts.moravek.com/DataSheets/MC2321DS.pdfMC-2321 Oxaliplatin,...
Transcript of MC-2321 - Moravek, Incproducts.moravek.com/DataSheets/MC2321DS.pdfMC-2321 Oxaliplatin,...
MC-2321
Oxaliplatin, [cyclohexane-ring-14C(U)]-
Lot 177-141-054-A-20090128-JI
A) All chromatograms were run using the HPLC method described on the Product Data Sheet.
Concentrations and volumes:
Standard solution concentration was 1.0 mg/mL.
Oxaliplatin, [cyclohexane-ring-14C(U)]- concentration was 160.0 µCi/mL. Volume of standard alone injection was 5.0 µL.
Volume of Oxaliplatin, [cyclohexane-ring-14C(U)]- alone injection was 1.5 µL.
Co-injection solution consisted of 0.5 µL Oxaliplatin, [cyclohexane-ring-14C(U)]- + 5.0 µL standard.
Volume of co-injection was 5.5 µL.
Volume of blank injection was 1.5 µL.
B) Mass spectrometry- Positive Mode C) NMR
MC-2321
Oxaliplatin, [cyclohexane-ring-14C(U)]-
Lot 177-141-054-A-20090128-JI
Chromatogram Info:
File Name : V:\ReIntgtd\int6890 File Created : 1/28/2009 4:10:04 PM
Origin : Save File C:\Labdata\int6890.PRM As V:\ReIntgtd\int6890.PRM Acquired Date : 1/27/2009 3:06:50 PM
Project : Test By : Administrator
Method : Unit6-40minrun By : Administrator
Description : Radiochemical trace of 14C material alone
Created : 7/14/2007 11:10 AM Modified : 10/30/2012 4:07 PM
Column : Detection : Radiochemical
Mobile Phase : Temperature :
Flow Rate : Pressure :
Note :
[min.]Time
10 20 30 40
[V]
Volta
ge
0.0
0.5
1.0
1.5
2.0
2.5
4.6
1
6.5
2
7.6
3
8.1
4
12.8
5
14.2
6
V:\ ReI nt gt d\ in t 6890 - Unit 6 Radio
10/30/2012 4:08 PM Page 1 of 2Chromatogram V:\ReIntgtd\int6890.PRM
Result Table (Uncal - V:\ReIntgtd\int6890 - Unit 6 Radio)
Reten. Time[min]
Area[mV.s]
Height[mV]
Area[%]
Height[%]
W05[min]
1 4.603 45.805 1.143 0.09 0.0 0.47
2 6.490 15.276 1.017 0.03 0.0 0.21
3 7.607 14.315 1.160 0.03 0.0 0.22
4 8.053 32.617 1.484 0.07 0.1 0.36
5 12.807 33.442 1.345 0.07 0.0 0.24
6 14.207 49287.175 2737.697 99.71 99.8 0.26
Total 49428.630 2743.848 100.00 100.0
10/30/2012 4:08 PM Page 2 of 2Chromatogram V:\ReIntgtd\int6890.PRM
MC-2321
Oxaliplatin, [cyclohexane-ring-14C(U)]-
Lot 177-141-054-A-20090128-JI
Chromatogram Info:
File Name : V:\ReIntgtd\int6890 File Created : 1/28/2009 4:10:04 PM
Origin : Save File C:\Labdata\int6890.PRM As V:\ReIntgtd\int6890.PRM Acquired Date : 1/27/2009 3:06:50 PM
Project : Test By : Administrator
Method : Unit6-40minrun By : Administrator
Description : UV trace of 14C material alone
Created : 7/14/2007 11:10 AM Modified : 10/30/2012 4:08 PM
Column : Detection : UV 255nm
Mobile Phase : Temperature :
Flow Rate : Pressure :
Note :
[min.]Time
10 20 30 40
[mV]
Volta
ge
50
100
150
200 13.8
1
V:\ ReI nt gt d\ in t 6890 - Unit 6 UV
10/30/2012 4:08 PM Page 1 of 2Chromatogram V:\ReIntgtd\int6890.PRM
Result Table (Uncal - V:\ReIntgtd\int6890 - Unit 6 UV)
Reten. Time[min]
Area[mV.s]
Height[mV]
Area[%]
Height[%]
W05[min]
1 13.843 901.127 146.011 100.00 100.0 0.09
Total 901.127 146.011 100.00 100.0
10/30/2012 4:08 PM Page 2 of 2Chromatogram V:\ReIntgtd\int6890.PRM
MC-2321
Oxaliplatin, [cyclohexane-ring-14C(U)]-
Lot 177-141-054-A-20090128-JI
Chromatogram Info:
File Name : V:\ReIntgtd\int6892 File Created : 10/30/2012 3:51:04 PM
Origin : Acquired Acquired Date : 1/28/2009 1:49:10 PM
Project : Test By : Administrator
Method : Unit6-40minrun By : Administrator
Description : UV trace of standard alone
Created : 7/14/2007 11:10 AM Modified : 10/30/2012 4:09 PM
Column : Detection : UV 255nm
Mobile Phase : Temperature :
Flow Rate : Pressure :
Note :
[min.]Time
10 20 30 40
[mV]
Volta
ge
100
200
300
400
500
3.8
1
13.8
2
33.7
3
V:\ ReI nt gt d\ in t 6892 - Unit 6 UV
10/30/2012 4:10 PM Page 1 of 2Chromatogram V:\ReIntgtd\int6892.PRM
Result Table (Uncal - V:\ReIntgtd\int6892 - Unit 6 UV)
Reten. Time[min]
Area[mV.s]
Height[mV]
Area[%]
Height[%]
W05[min]
1 3.833 11.852 0.472 0.68 0.1 0.39
2 13.823 1682.362 363.122 96.81 99.1 0.07
3 33.737 43.522 2.997 2.50 0.8 0.17
Total 1737.735 366.590 100.00 100.0
10/30/2012 4:10 PM Page 2 of 2Chromatogram V:\ReIntgtd\int6892.PRM
MC-2321
Oxaliplatin, [cyclohexane-ring-14C(U)]-
Lot 177-141-054-A-20090128-JI
Chromatogram Info:
File Name : V:\ReIntgtd\int6894 File Created : 10/30/2012 3:51:04 PM
Origin : Acquired Acquired Date : 1/28/2009 3:46:48 PM
Project : Test By : Administrator
Method : Unit6-40minrun By : Administrator
Description : Radiochemical trace of 14C material co-injected with standard
Created : 7/14/2007 11:10 AM Modified : 10/30/2012 4:11 PM
Column : Detection : Radiochemical
Mobile Phase : Temperature :
Flow Rate : Pressure :
Note :
[min.]Time
10 20 30 40
[V]
Volta
ge
0.0
0.5
1.0
1.5
2.0
2.5
4.6
1
5.1
2
7.4
3
11.7
4
13.1
5
15.1
6
15.7
7
16.2
8
18.1
9
V:\ ReI nt gt d\ in t 6894 - Unit 6 Radio
10/30/2012 4:11 PM Page 1 of 2Chromatogram V:\ReIntgtd\int6894.PRM
Result Table (Uncal - V:\ReIntgtd\int6894 - Unit 6 Radio)
Reten. Time[min]
Area[mV.s]
Height[mV]
Area[%]
Height[%]
W05[min]
1 4.623 12.577 1.020 0.03 0.0 0.22
2 5.073 8.783 0.745 0.02 0.0 0.20
3 7.423 36.283 2.358 0.08 0.1 0.26
4 11.727 65.901 1.932 0.14 0.1 0.40
5 13.127 46855.570 2631.195 99.49 99.6 0.25
6 15.063 5.857 0.442 0.01 0.0 0.09
7 15.663 8.884 0.699 0.02 0.0 0.21
8 16.230 16.622 0.900 0.04 0.0 0.37
9 18.097 87.485 1.609 0.19 0.1 0.22
Total 47097.963 2640.900 100.00 100.0
10/30/2012 4:11 PM Page 2 of 2Chromatogram V:\ReIntgtd\int6894.PRM
MC-2321
Oxaliplatin, [cyclohexane-ring-14C(U)]-
Lot 177-141-054-A-20090128-JI
Chromatogram Info:
File Name : V:\ReIntgtd\int6894 File Created : 10/30/2012 3:51:04 PM
Origin : Acquired Acquired Date : 1/28/2009 3:46:48 PM
Project : Test By : Administrator
Method : Unit6-40minrun By : Administrator
Description : UV trace of 14C material co-injected with standard
Created : 7/14/2007 11:10 AM Modified : 10/30/2012 4:12 PM
Column : Detection : UV 255nm
Mobile Phase : Temperature :
Flow Rate : Pressure :
Note :
[min.]Time
10 20 30 40
[mV]
Volta
ge
100
200
300
400
500
3.9
1
12.8
2
33.9
3
V:\ ReI nt gt d\ in t 6894 - Unit 6 UV
10/30/2012 4:12 PM Page 1 of 2Chromatogram V:\ReIntgtd\int6894.PRM
Result Table (Uncal - V:\ReIntgtd\int6894 - Unit 6 UV)
Reten. Time[min]
Area[mV.s]
Height[mV]
Area[%]
Height[%]
W05[min]
1 3.910 10.051 0.460 0.43 0.1 0.35
2 12.760 2284.990 385.011 97.75 99.1 0.09
3 33.933 42.662 3.059 1.82 0.8 0.15
Total 2337.703 388.531 100.00 100.0
10/30/2012 4:12 PM Page 2 of 2Chromatogram V:\ReIntgtd\int6894.PRM
MC-2321
Oxaliplatin, [cyclohexane-ring-14C(U)]-
Lot 177-141-054-A-20090128-JI
Chromatogram Info:
File Name : V:\ReIntgtd\int6891 File Created : 10/30/2012 3:51:04 PM
Origin : Acquired Acquired Date : 1/28/2009 12:38:19 PM
Project : Test By : Administrator
Method : Unit6-40minrun By : Administrator
Description : UV trace of blank injection
Created : 7/14/2007 11:10 AM Modified : 10/30/2012 4:13 PM
Column : Detection : UV 255nm
Mobile Phase : Temperature :
Flow Rate : Pressure :
Note :
[min.]Time
0 10 20 30 40
[mV]
Volta
ge
50
60
70
80
90
100V:\ ReI nt gt d\ in t 6891 - Unit 6 UV
10/30/2012 4:13 PM Page 1 of 2Chromatogram V:\ReIntgtd\int6891.PRM
Result Table (Uncal - V:\ReIntgtd\int6891 - Unit 6 UV)
Reten. Time[min]
Area[mV.s]
Height[mV]
Area[%]
Height[%]
W05[min]
No peak to report
10/30/2012 4:13 PM Page 2 of 2Chromatogram V:\ReIntgtd\int6891.PRM
C:\Xcalibur\data\MC2321-20090128-JI 9/2/2010 1:16:27 PM MC2321-20090128-JI
RT: 0.00 - 1.99
0.0 0.5 1.0 1.5
Time (min)
0
5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
95
100
Relative Abundance
1.830.08 0.15
0.20
0.24
0.35 0.45
0.51
0.600.66
0.80
1.23
0.94
NL:7.88E6
TIC F: MS MC2321-20090128-JI
MC2321-20090128-JI#1-160 RT: 0.00-1.99T: + c Q3MS [ 368.00-428.00]m/z= 386.93-413.71
m/z Intensity Relativem/z Intensity Relative
391.28 49898.7 7.26 392.26 24372.3 3.54 393.31 50543.8 7.35 394.24 70936.8 10.32 395.21 93740.4 13.63 396.23 95507.6 13.89 397.15 615447.7 89.50 398.15 669823.3 97.40 399.14 687672.7 100.00 400.15 263001.2 38.25 401.15 461566.3 67.12 402.15 229207.5 33.33 403.15 244153.0 35.50 404.15 69975.2 10.18 405.15 101741.3 14.80 406.17 35961.1 5.23 407.17 44019.0 6.40 409.23 25288.7 3.68
MC2321-20090128-JI #1-160 RT: 0.00-1.99 AV: 160 NL: 6.88E5T: + c Q3MS [ 368.00-428.00]
370 380 390 400 410 420
m/z
0
10
20
30
40
50
60
70
80
90
100
Relative Abundance
399.14
397.15
401.15
403.15
419.26405.15396.23
415.29420.20
393.31371.34 407.17379.42 425.20385.27
98
76
54
32
1pp
m1.0541.0881.1931.2231.4621.489
1.9371.9772.2432.271
4.14
1.91
2.012.00
PC 1.00
GB 0
LB 2.70 Hz
SSB 0
WDW EM
SF 300.1300000 MHz
SI 32768
F2 − Processing parameters
SFO1 300.1318534 MHz
PL1 0.00 dB
P1 10.25 usec
NUC1 1H
======== CHANNEL f1 ========
TD0 1
D1 1.00000000 sec
TE 300.0 K
DE 6.00 usec
DW 81.000 usec
RG 362
AQ 5.3084660 sec
FIDRES 0.094190 Hz
SWH 6172.839 Hz
DS 2
NS 500
SOLVENT D2O
TD 65536
PULPROG zg30
PROBHD 5 mm DUX 3H−1H
INSTRUM spect
Time 14.13
Date_ 20090325
F2 − Acquisition Parameters
PROCNO 1
EXPNO 1
NAME MC2321
Current Data Parameters
Batch 20090128−JI
MC2321 1H NMR in D2O