AssayIndex
Cross-section

Liraglutide impurity profile

Every named species the index has reported alongside Liraglutide, how often, at what level, and what its presence implies about the synthesis or the handling. Reporting threshold is 0.05 % area; anything below it is invisible to this page and is silently added to the main peak.

154 recordsmedian 99.02 %spec 97.5 %
Median total impurities 0.98% n=154
Median largest single 0.48% n=154
Worst single observed 2.12% n=154
Named species observed 6 / 6 n=6
Named speciesΔRT (min)Δ mass (Da)Seen inMedian % areaMax % area
γ-Glu regioisomer+0.41mass-identical92%0.081.19
des-palmitoyl liraglutide (−238 Da)-3.44-238.23087%0.181.49
deamidated (Asn→Asp, +1 Da)-0.48+0.98483%0.161.77
palmitoyl bis-adduct (+238 Da)+2.88+238.23079%0.062.12
des-His1 truncate (−137 Da)-1.02-137.05978%0.111.93
liraglutide dimer+3.15+3748.96367%0.070.51

γ-Glu regioisomer

Retention offset from the main peak
+0.41 min on RG-2
Mass difference
mass-identical — chromatography only
Reported in
141 of 154 records (92 %)
Level when reported
median 0.08 %, max 1.19 %
Resolution requirement
A gradient long enough to separate it. No mass spectrometer will.

des-palmitoyl liraglutide (−238 Da)

Retention offset from the main peak
-3.44 min on RG-2
Mass difference
-238.230 Da
Reported in
134 of 154 records (87 %)
Level when reported
median 0.18 %, max 1.49 %
Resolution requirement
Baseline-resolved on the reference method.

deamidated (Asn→Asp, +1 Da)

Retention offset from the main peak
-0.48 min on RG-2
Mass difference
+0.984 Da
Reported in
128 of 154 records (83 %)
Level when reported
median 0.16 %, max 1.77 %
Resolution requirement
Baseline-resolved on the reference method.

palmitoyl bis-adduct (+238 Da)

Retention offset from the main peak
+2.88 min on RG-2
Mass difference
+238.230 Da
Reported in
121 of 154 records (79 %)
Level when reported
median 0.06 %, max 2.12 %
Resolution requirement
Baseline-resolved on the reference method.

des-His1 truncate (−137 Da)

Retention offset from the main peak
-1.02 min on RG-2
Mass difference
-137.059 Da
Reported in
120 of 154 records (78 %)
Level when reported
median 0.11 %, max 1.93 %
Resolution requirement
Baseline-resolved on the reference method.

liraglutide dimer

Retention offset from the main peak
+3.15 min on RG-2
Mass difference
+3748.963 Da
Reported in
103 of 154 records (67 %)
Level when reported
median 0.07 %, max 0.51 %
Resolution requirement
Baseline-resolved on the reference method.

Degradation pathways

Degradants are a handling finding rather than a synthesis finding. A lot that shipped clean and arrived oxidised tells you about the courier, not the chemist.

  • palmitoyl amide hydrolysis under alkaline conditions
  • fibrillation at the isoelectric point (pH ≈ 4.6) — avoid acidic reconstitution