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