A specification is a decision and a result is a measurement. Where a template puts one in the other's field the fix is editorial, and the numbers behind it reconcile fine — 98.05 % here against the declared figure.
AX-2025-020574
Tirzepatide · 5 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2502-D7226
MARGINALPURITY ONLY
- Report ID
- AX-2025-020574
- Compound
- Tirzepatide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
- Batch / lot
- SSA-2502-D7226
- Declared label claim
- 5mg
- Laboratory
- Nordanalyt Laboratories
- Assay date
- 20 Jul 2025
- Submitted
- 02 Aug 2025
- Quarter
- 2025-Q3
- Submitter
- Contributor #E-6741
- Sample provenance
- Buyer-sourced
Section 1
Results
Measured against the index acceptance specification for the incretin analogues and co-agonists class. A specification is a decision the index made; a result is a measurement. See where each threshold came from.
| Parameter | Method | Result | Unit | Index spec | |
|---|---|---|---|---|---|
| Purity | RP-HPLC, 35 min gradient, 214 nm | 98.05 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.95 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — [D-Aib13]-diastereomer | 0.98 | % area | ≤ 1.00 | PASS |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Peptide content | not ordered on this submission | not determined | — | required to check label claim | NOT TESTED |
| Water content | Karl Fischer, coulometric, duplicate | 6.69 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 6.86 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.75 | % | — | NOT TESTED |
| Endotoxin | not ordered on this submission | not determined | — | ≤ 5.0 | NOT TESTED |
| Sterility | not ordered on this submission | not determined | — | no growth | NOT TESTED |
| Appearance | visual, diffuse light, black and white background | Off-white lyophilised cake, intact | — | white to off-white intact cake | PASS |
| Reconstitution clarity | reconstituted per submitter procedure | Clear, colourless, no visible particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 3.33 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 35 min gradient | 22.93 | min | 22.91 ± 0.45 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.44 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 64,026 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib13]-diastereomer | 0.60 | — | no index criterion | REPORTED |
Section 2
Chromatogram and peak integration
The figure is drawn from the table. It is not an independent illustration — if a number in the table changed, the trace would change with it.
| # | Peak | RT | Area (µV·s) | % area | Δ mass (Da) |
|---|---|---|---|---|---|
| 1 | Tirzepatide — main peak | 22.93 | 4,765,534 | 98.05 | — |
| 2 | [D-Aib13]-diastereomer | 22.71 | 47,631 | 0.98 | 0.000 |
| 3 | des-Gly deletion (−57 Da) | 22.22 | 29,648 | 0.61 | -57.021 |
| 4 | C20 diacid mono-amide | 24.82 | 7,290 | 0.15 | +0.984 |
| 5 | truncated (3-39) | 21.20 | 5,346 | 0.11 | -222.112 |
| 6 | tirzepatide dimer | 27.57 | 3,402 | 0.07 | +4810.410 |
| 7 | des-Aib2 analogue | 22.52 | 1,458 | 0.03 | -85.053 |
| Closure check — purity + Σ impurities | 100.00 | CLOSES | |||
Reporting threshold 0.05 % area. Peaks below it are not reported and are therefore excluded from the total, which overstates purity by their sum — see peak integration.
Section 4
Gravimetric mass balance
Water, counter-ion, residual and total peptide content are exhaustive and mutually exclusive categories. They must account for 100 % of the cake mass. The index closes this to within 0.02 pp and the build asserts it.
Supplier certificate, as declared
The supplier's own figures for this lot, beside the independent measurement. Divergence is assessed against the batch median, not against this single report — see rule AX-R05.
| Figure | Supplier COA | This report | Index note |
|---|---|---|---|
| Purity (% area) | 97.5 | 98.05 | divergence -0.44 pp vs batch median |
| Total impurities (% area) | 2.50 | 1.95 | |
| Largest single impurity (% area) | not stated | 0.98 | |
| Water (%) | 4.6 | 6.69 | |
| Counter-ion (%) | not stated | 6.86 | |
| Peptide content (%w/w) | 90.6 | not determined | |
| Endotoxin (EU/mg) | not stated | not determined | |
| Method stated on certificate | YES | — | column, gradient and wavelength given |
Section 5
Provenance and caveats
Where a sample came from changes the weight of the evidence. The index treats it as a first-class field.
- Sample provenance
- Buyer-sourced
- Evidentiary weight
- Strongest available evidence in this index.
- Chain of custody
- Retail purchase → third-party forwarder (8 d) → laboratory (courier, cold pack, 3 d) → assay.
- Assay date
- 20 Jul 2025
- Submitted to the index
- 02 Aug 2025
- Laboratory
- Nordanalyt Laboratories, Uppsala, Sweden
- Method basis
- 35 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
Section 6
Annotations 3
Signed technical comments from index contributors. Not a discussion forum — annotations question or contextualise the result, and the data team replies where a reply is warranted.
What resolves this in one email is the batch record rather than the summary sheet: the integration report at full precision, with the reporting threshold stated. It is routinely available.
The more useful question than the rounding is whether the certificate states the method. Where it does, a rounded figure is comparable; where it does not, an unrounded one still is not.
Section 7
Related records
Same batch — lot SSA-2502-D7226 n=13
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-020572 | SSA-2502-D7226 | Medutest | 2025-Q3 | 98.55 | 6.24 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2025-020573 | SSA-2502-D7226 | Janoshik | 2025-Q3 | 97.89 | 6.94 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2025-020575 | SSA-2502-D7226 | VendorInvestigate | 2025-Q3 | 97.94 | 6.51 | — | Buyer-sourced | 2 | FAIL |
| AX-2025-020576 | SSA-2502-D7226 | Nordanalyt | 2025-Q3 | 97.20 | 7.21 | 95.0 | Buyer-sourced | 1 | MARGINAL |
| AX-2025-020577 | SSA-2502-D7226 | Janoshik | 2025-Q3 | 98.09 | 6.21 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2025-020578 | SSA-2502-D7226 | Janoshik | 2025-Q3 | 97.84 | 7.06 | 92.1 | Buyer-sourced | 1 | MARGINAL |
| AX-2025-020579 | SSA-2502-D7226 | Medutest | 2025-Q3 | 97.88 | 6.67 | 89.7 | Buyer-sourced | 2 | MARGINAL |
| AX-2025-020580 | SSA-2502-D7226 | PeptideMeter | 2025-Q3 | 98.05 | 6.90 | — | Laboratory-retained | 1 | MARGINAL |
| AX-2025-020581 | SSA-2502-D7226 | Janoshik | 2025-Q3 | 97.83 | 6.53 | 96.6 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-020582 | SSA-2502-D7226 | PeptideMeter | 2025-Q3 | 97.70 | 6.61 | 100.1 | Laboratory-retained | 1 | MARGINAL |
| AX-2025-020583 | SSA-2502-D7226 | Kestrel | 2025-Q3 | 99.04 | 7.10 | 104.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-020584 | SSA-2502-D7226 | PeptideMeter | 2025-Q3 | 97.97 | 6.65 | 101.5 | Buyer-sourced | 1 | MARGINAL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043288 | CPC | CPC-2607-L1516 | Janoshik | 2026-Q3 | 96.89 | 5.11 | 101.1 | Laboratory-retained | 0 | FAIL |
| AX-2026-041610 | FGP | FGP-2603-L7753 | Janoshik | 2026-Q3 | 98.81 | 2.45 | 101.0 | Buyer-sourced | 0 | PASS |
| AX-2026-041974 | AMB | AMB-2603-C5112 | Nordanalyt | 2026-Q3 | 98.20 | 3.41 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041975 | AMB | AMB-2603-C5112 | Medutest | 2026-Q3 | 97.88 | 3.45 | 106.9 | Laboratory-retained | 0 | PASS |
| AX-2026-041609 | FGP | FGP-2603-L7753 | Janoshik | 2026-Q3 | 98.52 | 2.00 | 98.0 | Buyer-sourced | 0 | PASS |
| AX-2026-041978 | AMB | AMB-2603-C5112 | Janoshik | 2026-Q3 | 97.94 | 3.57 | 103.0 | Buyer-sourced | 0 | PASS |
| AX-2026-041982 | AMB | AMB-2603-C5112 | Janoshik | 2026-Q3 | 97.60 | 4.46 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043286 | CPC | CPC-2607-L1516 | Kestrel | 2026-Q3 | 98.20 | 4.56 | — | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043135 | BPC-157 | SSA-2601-N6863 | Nordanalyt | 2026-Q2 | 98.16 | 4.66 | 92.8 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043160 | GHK-Cu | SSA-2604-V7731 | Janoshik | 2026-Q2 | 98.01 | 4.02 | 91.8 | Buyer-sourced | 0 | PASS |
| AX-2026-043157 | GHK-Cu | SSA-2604-V7731 | Medutest | 2026-Q2 | 99.19 | 5.14 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043141 | BPC-157 | SSA-2601-N6863 | Janoshik | 2026-Q2 | 98.06 | 4.06 | 94.6 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043154 | GHK-Cu | SSA-2604-V7731 | PeptideMeter | 2026-Q2 | 97.82 | 4.82 | 101.6 | Buyer-sourced | 0 | PASS |
| AX-2026-043137 | BPC-157 | SSA-2601-N6863 | PeptideMeter | 2026-Q2 | 98.17 | 4.14 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043162 | GHK-Cu | SSA-2604-V7731 | Janoshik | 2026-Q2 | 98.50 | 4.36 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043134 | BPC-157 | SSA-2601-N6863 | Medutest | 2026-Q2 | 97.89 | 4.01 | — | Buyer-sourced | 1 | FAIL |