APPLICATION ID 1509

Entecavir Monohydrate

COMPOUND IDENTIFICATION

Compound Name Entecavir Monohydrate
Entecavir Monohydrate

CHROMATOGRAM

Chromatogram

ANALYTICAL REPORT

Column Trade Name

Column Size / Particle Size

CHIRALPAK® IE

250 x 4.6mm / 5µm

Mobile Phase Composition

ethanol / methanol / diethylamine = 90 / 10 / 0.1

Chromatographic Mode

Normal Phase
Secondary screening solvent (Immobilised CSP)

Flow rate (ml/min)

0.7

Injection amount (mg)

0.0025

Temperature (°C)

25

Pressure (MPa)

Detection

UV 260 nm

Elution order

Enantiomer, API

No.

Rt

K’

1

5.82

0.36

2

7.67

0.79

Alpha Value

Resolution

1 - 2

2.21

4.23

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