AX-2026-042736
Tirzepatide · 60 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2510-L9923
- Report ID
- AX-2026-042736
- Compound
- Tirzepatide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- GGPeps — Nantong Guangyuan Chemical Co., Ltd.
- Batch / lot
- GGPE-2510-L9923
- Declared label claim
- 60mg
- Laboratory
- PeptideMeter
- Assay date
- 27 Feb 2026
- Submitted
- 20 Mar 2026
- Quarter
- 2026-Q1
- Submitter
- a.sandvik
- Sample provenance
- Buyer-sourced
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, 28 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 — des-Gly deletion (−57 Da) | 1.28 | % area | ≤ 1.00 | FAIL |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 4810.4103 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 4810.4387 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +5.9 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 88.26 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 86.54 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 68.94 | mg | 60 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 59.661 | mg | 60 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 99.4 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.18 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 7.37 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.19 | % | — | NOT TESTED |
| Endotoxin | not ordered on this submission | not determined | — | ≤ 5.0 | NOT TESTED |
| Sterility | membrane filtration, USP <71>, 14 d | No growth at 14 d | — | no growth | PASS |
| Appearance | visual, diffuse light, black and white background | White cake, partial shrinkage from vial wall | — | white to off-white intact cake | FAIL |
| 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 | 3.62 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 18.52 | min | 18.64 ± 0.45 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.90 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 66,228 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib13]-diastereomer | 0.60 | — | no index criterion | REPORTED |
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 | 18.52 | 4,765,534 | 98.05 | — |
| 2 | des-Gly deletion (−57 Da) | 17.95 | 62,212 | 1.28 | -57.021 |
| 3 | [D-Aib13]-diastereomer | 18.34 | 20,413 | 0.42 | 0.000 |
| 4 | Met(O) sulfoxide (+16 Da) | 17.83 | 8,263 | 0.17 | +15.995 |
| 5 | des-Aib2 analogue | 18.19 | 1,458 | 0.03 | -85.053 |
| 6 | trifluoroacetyl adduct (+96 Da) | 19.39 | 1,458 | 0.03 | +95.982 |
| 7 | truncated (3-39) | 17.14 | 972 | 0.02 | -222.112 |
| 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.
Mass spectrum and identity
Theoretical monoisotopic mass 4810.4103 Da, computed from C225H348N48O68. All ppm figures on this site are against monoisotopic values — see why that matters.
| Charge | Theoretical m/z | Observed m/z | Δ m/z | Rel. abundance (%) |
|---|---|---|---|---|
| 7+ | 688.2087 | 688.2128 | 0.0041 | 8.0 |
| 6+ | 802.7423 | 802.7471 | 0.0048 | 51.3 |
| 5+ | 963.0893 | 963.0950 | 0.0057 | 100.0 |
| 4+ | 1203.6099 | 1203.6170 | 0.0071 | 50.6 |
| 3+ | 1604.4774 | 1604.4868 | 0.0094 | 7.9 |
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.
| Component | Determination | %w/w of cake |
|---|---|---|
| Water | Karl Fischer | 4.18 |
| Counter-ion (TFA) | ion chromatography | 7.37 |
| Residual solvent + inorganic residue | estimated | 0.19 |
| Total peptide content | by difference | 88.26 |
| Total | 100.00 CLOSES | |
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) | 99.21 | 98.05 | divergence +1.16 pp vs batch median |
| Total impurities (% area) | not stated | 1.95 | |
| Largest single impurity (% area) | not stated | 1.28 | |
| Water (%) | not stated | 4.18 | |
| Counter-ion (%) | not stated | 7.37 | |
| Peptide content (%w/w) | not stated | 88.26 | |
| Endotoxin (EU/mg) | 0.71 | not determined | |
| Method stated on certificate | YES | — | column, gradient and wavelength given |
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 (34 d) → laboratory (courier, cold pack, 8 d) → assay.
- Assay date
- 27 Feb 2026
- Submitted to the index
- 20 Mar 2026
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- VERIFIED
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot GGPE-2510-L9923 n=5
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042732 | GGPE-2510-L9923 | Kestrel | 2026-Q1 | 99.08 | 3.65 | — | Supplier-supplied | 3 | MARGINAL |
| AX-2026-042733 | GGPE-2510-L9923 | VendorInvestigate | 2026-Q1 | 97.92 | 4.11 | 103.3 | Buyer-sourced | 2 | MARGINAL |
| AX-2026-042734 | GGPE-2510-L9923 | Janoshik | 2026-Q1 | 97.59 | 4.37 | — | Buyer-sourced | 2 | MARGINAL |
| AX-2026-042735 | GGPE-2510-L9923 | Janoshik | 2026-Q1 | 98.39 | 4.54 | 106.4 | Supplier-supplied | 3 | MARGINAL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043106 | KP | KP-2608-D5921 | PeptideMeter | 2026-Q3 | 98.90 | 5.45 | 105.4 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041742 | FGP | FGP-2603-L9714 | Janoshik | 2026-Q3 | 99.37 | 2.43 | 105.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043108 | KP | KP-2608-D5921 | Janoshik | 2026-Q3 | 99.70 | 5.45 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041741 | FGP | FGP-2603-L9714 | PeptideMeter | 2026-Q3 | 98.62 | 2.57 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043100 | KP | KP-2608-D5921 | VendorInvestigate | 2026-Q3 | 98.27 | 5.31 | 94.4 | Buyer-sourced | 2 | MARGINAL |
| AX-2026-043322 | CPC | CPC-2607-L2552 | Janoshik | 2026-Q3 | 96.79 | 4.88 | 96.1 | Supplier-supplied | 2 | FAIL |
| AX-2026-043111 | KP | KP-2608-D5921 | PeptideMeter | 2026-Q3 | 99.71 | 5.15 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043321 | CPC | CPC-2607-L2552 | Kestrel | 2026-Q3 | 97.84 | 5.34 | — | Supplier-supplied | 2 | MARGINAL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042737 | Selank | GGPE-2603-J9708 | Janoshik | 2026-Q3 | 98.40 | 9.14 | 97.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042804 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.50 | 7.97 | — | Supplier-supplied | 0 | FAIL |
| AX-2026-042803 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.48 | 8.01 | — | Laboratory-retained | 1 | FAIL |
| AX-2026-042802 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.74 | 7.09 | 96.0 | Supplier-supplied | 0 | FAIL |
| AX-2026-042796 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.26 | 7.56 | 97.5 | Buyer-sourced | 0 | FAIL |
| AX-2026-042648 | Melanotan II | GGPE-2603-P8735 | Janoshik | 2026-Q3 | 99.10 | 6.97 | — | Supplier-supplied | 4 | MARGINAL |
| AX-2026-042797 | Selank | GGPE-2602-G2056 | Medutest | 2026-Q3 | 98.46 | 7.92 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-042669 | CJC-1295 (no DAC) | GGPE-2606-E8495 | Medutest | 2026-Q3 | 98.61 | 4.06 | 95.5 | Supplier-supplied | 0 | PASS |