The certificate that arrives with a retail order is the certificate an ordinary buyer gets. Assessing it is assessing the real documentation practice rather than the sample-request one.
AX-2026-043742
Tirzepatide · 5 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2602-V8377
PASSPURITY ONLY
- Report ID
- AX-2026-043742
- Compound
- Tirzepatide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- BCH — Bachem Holding (Suzhou) Co., Ltd.
- Batch / lot
- BCH-2602-V8377
- Declared label claim
- 5mg
- Laboratory
- Medutest
- Assay date
- 15 Mar 2026
- Submitted
- 27 Mar 2026
- Quarter
- 2026-Q1
- Submitter
- b.stanescu
- 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, 25 min gradient, 214 nm | 99.00 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.00 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — trifluoroacetyl adduct (+96 Da) | 0.61 | % area | ≤ 1.00 | PASS |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 83.77 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 82.93 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 5.50 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 4.561 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 91.2 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.94 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 9.76 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.53 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 1.40 | EU/mg | ≤ 5.0 | PASS |
| Sterility | not ordered on this submission | not determined | — | no growth | NOT TESTED |
| Appearance | visual, diffuse light, black and white background | White powder, no defined cake (melt-back) | — | white to off-white intact cake | FAIL |
| Reconstitution clarity | reconstituted per submitter procedure | Clear after 90 s gentle swirling, no 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, 25 min gradient | 16.79 | min | 16.81 ± 0.45 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.06 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 60,095 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib13]-diastereomer | 0.56 | — | 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 | 16.79 | 4,811,707 | 99.00 | — |
| 2 | trifluoroacetyl adduct (+96 Da) | 17.56 | 29,648 | 0.61 | +95.982 |
| 3 | des-Aib2 analogue | 16.50 | 13,609 | 0.28 | -85.053 |
| 4 | des-Gly deletion (−57 Da) | 16.28 | 3,402 | 0.07 | -57.021 |
| 5 | Met(O) sulfoxide (+16 Da) | 16.17 | 1,458 | 0.03 | +15.995 |
| 6 | [D-Aib13]-diastereomer | 16.63 | 486 | 0.01 | 0.000 |
| 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.
| Component | Determination | %w/w of cake |
|---|---|---|
| Water | Karl Fischer | 5.94 |
| Counter-ion (TFA) | ion chromatography | 9.76 |
| Residual solvent + inorganic residue | estimated | 0.53 |
| Total peptide content | by difference | 83.77 |
| 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) | 98.91 | 99.00 | divergence +0.34 pp vs batch median |
| Total impurities (% area) | 1.09 | 1.00 | |
| Largest single impurity (% area) | 0.76 | 0.61 | |
| Water (%) | not stated | 5.94 | |
| Counter-ion (%) | not stated | 9.76 | |
| Peptide content (%w/w) | not stated | 83.77 | |
| Endotoxin (EU/mg) | not stated | 1.40 | |
| 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
- Domestic warehouse despatch → submitter (2–8 °C, 31 d) → laboratory (courier, cold pack, 2 d) → assay.
- Assay date
- 15 Mar 2026
- Submitted to the index
- 27 Mar 2026
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- PURITY ONLY
Section 6
Annotations 2
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.
Integration boundary on a close pair contributes up to 0.45 pp of standard uncertainty on its own. That is the term to quote alongside 99.00 % rather than a resolution verdict.
Section 7
Related records
Same batch — lot BCH-2602-V8377 n=16
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043736 | BCH-2602-V8377 | VendorInvestigate | 2026-Q1 | 98.30 | 6.18 | 94.6 | Buyer-sourced | 0 | PASS |
| AX-2026-043737 | BCH-2602-V8377 | Janoshik | 2026-Q1 | 97.93 | 5.46 | 107.5 | Buyer-sourced | 0 | PASS |
| AX-2026-043738 | BCH-2602-V8377 | Janoshik | 2026-Q1 | 98.65 | 6.87 | 97.9 | Buyer-sourced | 0 | PASS |
| AX-2026-043739 | BCH-2602-V8377 | Medutest | 2026-Q1 | 98.48 | 6.28 | 104.2 | Buyer-sourced | 0 | PASS |
| AX-2026-043740 | BCH-2602-V8377 | VendorInvestigate | 2026-Q1 | 99.28 | 6.03 | 90.7 | Buyer-sourced | 0 | PASS |
| AX-2026-043741 | BCH-2602-V8377 | Medutest | 2026-Q1 | 99.06 | 5.51 | 98.8 | Buyer-sourced | 0 | PASS |
| AX-2026-043743 | BCH-2602-V8377 | Janoshik | 2026-Q1 | 98.13 | 5.67 | 102.6 | Buyer-sourced | 0 | PASS |
| AX-2026-043744 | BCH-2602-V8377 | Janoshik | 2026-Q1 | 98.74 | 6.28 | 95.2 | Buyer-sourced | 0 | PASS |
| AX-2026-043745 | BCH-2602-V8377 | Janoshik | 2026-Q1 | 98.72 | 5.45 | 105.5 | Buyer-sourced | 0 | PASS |
| AX-2026-043746 | BCH-2602-V8377 | Janoshik | 2026-Q1 | 98.36 | 5.94 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043747 | BCH-2602-V8377 | Janoshik | 2026-Q1 | 98.47 | 6.06 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043748 | BCH-2602-V8377 | Medutest | 2026-Q1 | 98.73 | 5.52 | 95.7 | Laboratory-retained | 1 | MARGINAL |
| AX-2026-043749 | BCH-2602-V8377 | Janoshik | 2026-Q1 | 98.52 | 6.34 | 92.7 | Buyer-sourced | 0 | PASS |
| AX-2026-043750 | BCH-2602-V8377 | Janoshik | 2026-Q1 | 98.49 | 5.85 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043751 | BCH-2602-V8377 | Janoshik | 2026-Q1 | 98.61 | 5.94 | 91.1 | Supplier-supplied | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043445 | CPC | CPC-2607-L3107 | PeptideMeter | 2026-Q3 | 97.16 | 4.43 | 102.8 | Supplier-supplied | 0 | PASS |
| AX-2026-042137 | TFC | TFC-2605-G7465 | Janoshik | 2026-Q3 | 98.55 | 6.50 | 92.6 | Buyer-sourced | 0 | PASS |
| AX-2026-042148 | TFC | TFC-2605-G7465 | Medutest | 2026-Q3 | 98.59 | 6.97 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043440 | CPC | CPC-2607-L3107 | VendorInvestigate | 2026-Q3 | 96.03 | 5.46 | 105.8 | Buyer-sourced | 0 | FAIL |
| AX-2026-042147 | TFC | TFC-2605-G7465 | Janoshik | 2026-Q3 | 98.50 | 6.41 | 89.5 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041734 | FGP | FGP-2603-L9122 | PeptideMeter | 2026-Q3 | 99.06 | 2.92 | 102.2 | Buyer-sourced | 0 | PASS |
| AX-2026-043448 | CPC | CPC-2607-L3107 | Medutest | 2026-Q3 | 97.21 | 5.42 | 107.0 | Supplier-supplied | 0 | PASS |
| AX-2026-042144 | TFC | TFC-2605-G7465 | Kestrel | 2026-Q3 | 98.64 | 6.08 | 102.1 | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043691 | BPC-157 | BCH-2603-L7768 | Janoshik | 2026-Q3 | 98.66 | 5.12 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043693 | BPC-157 | BCH-2603-L7768 | PeptideMeter | 2026-Q3 | 97.82 | 5.21 | 94.9 | Buyer-sourced | 0 | FAIL |
| AX-2026-043686 | BPC-157 | BCH-2603-L7768 | VendorInvestigate | 2026-Q3 | 97.64 | 5.27 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043695 | BPC-157 | BCH-2603-L7768 | Janoshik | 2026-Q3 | 97.61 | 5.42 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043726 | N-Acetyl Semax Amide | BCH-2602-E8475 | Janoshik | 2026-Q3 | 97.89 | 9.67 | 104.2 | Buyer-sourced | 0 | FAIL |
| AX-2026-043688 | BPC-157 | BCH-2603-L7768 | Janoshik | 2026-Q3 | 97.94 | 5.56 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043658 | BPC-157 | BCH-2603-G6644 | Janoshik | 2026-Q3 | 98.45 | 4.37 | 101.8 | Supplier-supplied | 0 | PASS |
| AX-2026-043692 | BPC-157 | BCH-2603-L7768 | VendorInvestigate | 2026-Q3 | 97.60 | 5.61 | — | Buyer-sourced | 0 | FAIL |