Blossmate ® Phenyl 2.1mm×100mm, 3.5 μm, 450Å Solve the problem of semaglutide residue

Test Report

Chromatography conditions:

Chromatogram and Data: 

Mass Spectrometry Conditions:
Ion Source: ESI

Detection Mode: MRM
Drying Gas: Nitrogen, 400 ℃,

Flow Rate: 1000 L/Hr
Collision Gas: Argon Ion

Spray Voltage:1kV

Solution preparation

1. Preparation of Mobile Phase:
0.1% Formic Acid Aqueous Solution: Take 0.05 mL of formic acid, dilute with water to 100 mL, mix well, and set aside;
0.02% Trifluoroacetic Acid Acetonitrile Solution: Take 0.1 mL of trifluoroacetic acid, dilute with acetonitrile to 500 mL, mix well, and set aside.

2. Preparation of Solutions:
Methanol-Water Solution (50+50): Take 100 mL of methanol, add an equal volume of water, mix well, and set aside.

3. Preparation of Standard Solutions:
Dissolve the Somatropin standard substance in pure water to a concentration of 1000 mg/L; Dilute the 1000 mg/L Somatropin standard substance with 50% methanol-water to concentrations of 20 mg/L, 1 mg/L, 50 ng/L, 20 ng/L, 10 ng/L, and 5 ng/L; The 1 mg/L Somatropin standard dilution solution is used for mass spectrometry tuning after adding an appropriate amount of formic acid.

4. Sample Volume:

1) 20 mg/L Standard Injection Solution:

2) Blank injection 1:

3) Blank injection 2:

4) Blank injection 3:

5) Blank injection 4:

6) Blank injection 5:

7) 5 ng/L standard solution:

8) 10 ng/L standard solution:

9) 20 ng/L standard solution:

10) 50 ng/L standard solution:

Conclusion:

Using the Welch Blossmate® Phenyl 2.1mm×100mm, 3.5 μm, 450Å HPLC column, after injecting the 20 mg/L Somatropin standard injection solution in the mobile phase system, blank solution (50% methanol-water) was injected. The first blank injection showed approximately 2 ng/mL, and subsequent blank injections showed no significant residue.