Tirzepatide impurity profile
Every named species the index has reported alongside Tirzepatide, 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.
Median total impurities
1.56%
n=576
Median largest single
0.79%
n=576
Worst single observed
2.72%
n=576
Named species observed
8 / 8
n=8
| Named species | ΔRT (min) | Δ mass (Da) | Seen in | Median % area | Max % area |
|---|---|---|---|---|---|
| [D-Aib13]-diastereomer | -0.19 | mass-identical | 85% | 0.17 | 2.72 |
| des-Aib2 analogue | -0.35 | -85.053 | 82% | 0.18 | 2.10 |
| Met(O) sulfoxide (+16 Da) | -0.74 | +15.995 | 76% | 0.10 | 2.19 |
| C20 diacid mono-amide | +1.62 | +0.984 | 69% | 0.11 | 1.66 |
| des-Gly deletion (−57 Da) | -0.61 | -57.021 | 67% | 0.13 | 1.63 |
| trifluoroacetyl adduct (+96 Da) | +0.93 | +95.982 | 66% | 0.08 | 2.37 |
| truncated (3-39) | -1.48 | -222.112 | 64% | 0.16 | 2.08 |
| tirzepatide dimer | +3.98 | +4810.410 | 36% | 0.05 | 0.89 |
[D-Aib13]-diastereomer
- Retention offset from the main peak
- -0.19 min on RG-2
- Mass difference
- mass-identical — chromatography only
- Reported in
- 491 of 576 records (85 %)
- Level when reported
- median 0.17 %, max 2.72 %
- Resolution requirement
- A gradient long enough to separate it. No mass spectrometer will.
des-Aib2 analogue
- Retention offset from the main peak
- -0.35 min on RG-2
- Mass difference
- -85.053 Da
- Reported in
- 475 of 576 records (82 %)
- Level when reported
- median 0.18 %, max 2.10 %
- Resolution requirement
- Baseline-resolved on the reference method.
Met(O) sulfoxide (+16 Da)
- Retention offset from the main peak
- -0.74 min on RG-2
- Mass difference
- +15.995 Da
- Reported in
- 437 of 576 records (76 %)
- Level when reported
- median 0.10 %, max 2.19 %
- Resolution requirement
- Baseline-resolved on the reference method.
C20 diacid mono-amide
- Retention offset from the main peak
- +1.62 min on RG-2
- Mass difference
- +0.984 Da
- Reported in
- 398 of 576 records (69 %)
- Level when reported
- median 0.11 %, max 1.66 %
- Resolution requirement
- Baseline-resolved on the reference method.
des-Gly deletion (−57 Da)
- Retention offset from the main peak
- -0.61 min on RG-2
- Mass difference
- -57.021 Da
- Reported in
- 384 of 576 records (67 %)
- Level when reported
- median 0.13 %, max 1.63 %
- Resolution requirement
- Baseline-resolved on the reference method.
trifluoroacetyl adduct (+96 Da)
- Retention offset from the main peak
- +0.93 min on RG-2
- Mass difference
- +95.982 Da
- Reported in
- 382 of 576 records (66 %)
- Level when reported
- median 0.08 %, max 2.37 %
- Resolution requirement
- Baseline-resolved on the reference method.
truncated (3-39)
- Retention offset from the main peak
- -1.48 min on RG-2
- Mass difference
- -222.112 Da
- Reported in
- 368 of 576 records (64 %)
- Level when reported
- median 0.16 %, max 2.08 %
- Resolution requirement
- Baseline-resolved on the reference method.
tirzepatide dimer
- Retention offset from the main peak
- +3.98 min on RG-2
- Mass difference
- +4810.410 Da
- Reported in
- 208 of 576 records (36 %)
- Level when reported
- median 0.05 %, max 0.89 %
- 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.
- Met14 oxidation on exposure to peroxide-bearing excipients or air-saturated diluent
- aspartimide formation at the Asp-Gly motif during synthesis, carried into the lot
- slow deamidation of Asn in reconstituted material stored above 8 °C