USP Plerixafor Injection: Assay and Organic Impurities- system suitability solution

LC Conditions

Column

Luna Omega 5 µm C18 100 Å, LC Column 250 x 4.6 mm, Ea

Brand

Luna Omega

Part No

00G-4785-E0

Phase Name

C18

Elution Type

Gradient

Mobile Phase

A: Methanol + Water + TFA (8.5:91.5:1)

B: Methanol + Water + TFA (50:50:1)

Gradient Profile

Step No.

Time(min)

%A

%B

1

0

100

0

2

20

100

0

3

32

48

52

4

33

10

90

5

34

10

90

6

34.1

100

0

7

40

100

0

Flow Rate

1.00 mL/min

Temperature

45°C

System

Agilent Technologies 1260 Infinity Agilent Technologies 1260 Infinity

Detection

LC/UV (DAD, PDA) @ 230 nm (nanometers)

Detection Info

Sample Notes

System Suitability Solution: 2mg/mL Plerixafor system suitability solution mixture