Integration is where purity is decided
Rule AX-R12 is added. The uncertainty budget shows that the choice between two integration conventions is larger than every other error source combined.
The index published its first uncertainty budget for a purity figure in 2026-Q1, and the exercise reordered the priorities.
The budget
| Source | Standard uncertainty (pp) |
|---|---|
| Relative response factors assumed to be unity | 0.10–0.30 |
| Integration boundary on an unresolved shoulder | 0.05–0.45 |
| Baseline placement | 0.08 |
| Peaks below the reporting threshold | 0.05 (systematic, one-directional) |
| Detector non-linearity | 0.06 |
| Column ageing across a sequence | 0.05 |
| Injection repeatability | 0.04 |
| Sample-preparation concentration error | 0.03 |
Combined standard uncertainty for a well-resolved main peak comes out at 0.24 pp, giving an expanded uncertainty of roughly 0.48 pp at 95 % confidence. With an unresolved shoulder it roughly doubles to 1.0 pp.
Three conclusions
- Differences under 0.3 pp are not findings. They are inside the expanded uncertainty of either measurement. The index does not treat them as findings and readers should not either.
- The empirical and theoretical numbers agree. Measured inter-lab limits of agreement run ±0.44 to ±0.52 pp for the high-volume laboratories, close to the calculated expanded uncertainty. That agreement is reassuring about both.
- Rule AX-R05's threshold is justified. Its 1.5 pp trigger is roughly three times the expanded uncertainty of a well-behaved measurement, which is why the index is willing to call a divergence above it a finding.
Rule AX-R12
The largest controllable term in the budget is the integration boundary on an unresolved shoulder, so the index added a rule for it: peak asymmetry above 1.50, or resolution below 1.20 to the nearest named impurity. Either condition makes the reported purity a range rather than a number, and the record is marked integration-limited.
Tirzepatide accounts for a disproportionate share of instances, because its des-Aib2 impurity elutes 0.35 min early and frequently appears as an unresolved leading shoulder. Retatrutide and the other multi-Aib analogues follow for the same reason.
| Compound | Records | Median purity | Suppliers |
|---|---|---|---|
| BPC-157 | 85 | 98.95 | 10 |
| Semaglutide | 79 | 98.96 | 7 |
| Retatrutide | 67 | 98.75 | 8 |
| Tirzepatide | 66 | 98.37 | 9 |
| Semax | 58 | 99.56 | 5 |
| CJC-1295 with DAC | 50 | 98.84 | 7 |
| TB-500 | 49 | 99.68 | 7 |
| Melanotan II | 40 | 99.33 | 4 |
| Ipamorelin | 29 | 99.53 | 6 |
| MK-677 (Ibutamoren mesylate) | 29 | 98.42 | 4 |
| Selank | 22 | 99.92 | 4 |
| Epitalon | 19 | 98.44 | 2 |