APPLICATION ID 1520

Lurasidone

COMPOUND IDENTIFICATION

Compound Name Lurasidone
Lurasidone

CHROMATOGRAM

Chromatogram

ANALYTICAL REPORT

Column Trade Name

Column Size / Particle Size

CHIRALPAK® IE-3

250 x 4.6mm / 3µm

Mobile Phase Composition

n-hexane / ethanol / tetrahydrofuran / diethylamine = 80 / 10 / 10 / 0.1

Chromatographic Mode

Normal Phase
Primary screening solvent (Immobilised CSP)

Flow rate (ml/min)

1

Injection amount (mg)

0.0075

Temperature (°C)

25

Pressure (MPa)

Detection

UV 320 nm

Elution order

t1,t2=API, t3,t4,t5,t6,t7=Enantiomer

No.

Rt

K’

1

10.53

2.21

2

11.03

2.68

3

15.43

4.14

4

16.08

4.36

5

18.74

5.25

6

20.32

5.77

7

25.31

7.44

8

34.44

10.48

Alpha Value

Resolution

1 - 2

1.07

1.46

2 - 3

1.55

9.47

3 - 4

1.05

1.14

4 - 5

1.2

4.28

5 - 6

1.1

2.24

6 - 7

1.29

5.63

7 - 8

1.41

7.22

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