AX-2025-021328
Tirzepatide · 60 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2508-A7959
PASSVERIFIED
- Report ID
- AX-2025-021328
- Compound
- Tirzepatide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- BCH — Bachem Holding (Suzhou) Co., Ltd.
- Batch / lot
- BCH-2508-A7959
- Declared label claim
- 60mg
- Laboratory
- Janoshik Analytical
- Assay date
- 22 Sep 2025
- Submitted
- 27 Sep 2025
- Quarter
- 2025-Q3
- Submitter
- j.serrano
- 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, 30 min gradient, 214 nm | 98.82 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.18 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — C20 diacid mono-amide | 0.63 | % area | ≤ 1.00 | PASS |
| 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 | 88.07 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 87.03 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 70.96 | mg | 60 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 61.756 | mg | 60 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 102.9 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.30 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 6.44 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.19 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 1.08 | EU/mg | ≤ 5.0 | PASS |
| Sterility | membrane filtration, USP <71>, 14 d | No growth at 14 d | — | no growth | PASS |
| Appearance | visual, diffuse light, black and white background | 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 | 3.86 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 19.84 | min | 19.86 ± 0.45 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.29 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 66,754 | — | ≥ 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 | 19.84 | 4,802,958 | 98.82 | — |
| 2 | C20 diacid mono-amide | 21.46 | 30,620 | 0.63 | +0.984 |
| 3 | [D-Aib13]-diastereomer | 19.65 | 11,179 | 0.23 | 0.000 |
| 4 | des-Aib2 analogue | 19.49 | 8,263 | 0.17 | -85.053 |
| 5 | tirzepatide dimer | 23.82 | 3,888 | 0.08 | +4810.410 |
| 6 | des-Gly deletion (−57 Da) | 19.23 | 3,402 | 0.07 | -57.021 |
| 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 3
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 | 8.6 |
| 6+ | 802.7423 | 802.7471 | 0.0048 | 54.6 |
| 5+ | 963.0893 | 963.0950 | 0.0057 | 100.0 |
| 4+ | 1203.6099 | 1203.6170 | 0.0071 | 50.2 |
| 3+ | 1604.4774 | 1604.4868 | 0.0094 | 8.5 |
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 | 5.30 |
| Counter-ion (TFA) | ion chromatography | 6.44 |
| Residual solvent + inorganic residue | estimated | 0.19 |
| Total peptide content | by difference | 88.07 |
| 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) | 98.72 | 98.82 | divergence -0.19 pp vs batch median |
| Total impurities (% area) | 1.28 | 1.18 | |
| Largest single impurity (% area) | 0.73 | 0.63 | |
| Water (%) | not stated | 5.30 | |
| Counter-ion (%) | not stated | 6.44 | |
| Peptide content (%w/w) | not stated | 88.07 | |
| Endotoxin (EU/mg) | not stated | 1.08 | |
| 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 → submitter (ambient, 16 d) → laboratory (courier, cold pack, 2 d) → assay.
- Assay date
- 22 Sep 2025
- Submitted to the index
- 27 Sep 2025
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- VERIFIED
Section 6
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Section 7
Related records
Same batch — lot BCH-2508-A7959 n=12
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-021325 | BCH-2508-A7959 | Janoshik | 2025-Q3 | 98.77 | 5.14 | 91.5 | Buyer-sourced | 1 | FAIL |
| AX-2025-021326 | BCH-2508-A7959 | Medutest | 2025-Q3 | 98.90 | 5.13 | 102.7 | Laboratory-retained | 0 | PASS |
| AX-2025-021327 | BCH-2508-A7959 | Medutest | 2025-Q3 | 99.28 | 5.50 | 89.2 | Buyer-sourced | 1 | MARGINAL |
| AX-2025-021329 | BCH-2508-A7959 | Janoshik | 2025-Q3 | 98.34 | 5.23 | 94.3 | Buyer-sourced | 0 | PASS |
| AX-2025-021330 | BCH-2508-A7959 | Janoshik | 2025-Q3 | 98.89 | 5.09 | — | Buyer-sourced | 0 | PASS |
| AX-2025-021331 | BCH-2508-A7959 | Nordanalyt | 2025-Q3 | 99.15 | 4.76 | 101.2 | Supplier-supplied | 0 | PASS |
| AX-2025-021332 | BCH-2508-A7959 | Janoshik | 2025-Q3 | 98.91 | 5.40 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2025-021333 | BCH-2508-A7959 | Janoshik | 2025-Q3 | 99.30 | 5.52 | 102.9 | Supplier-supplied | 0 | PASS |
| AX-2025-021334 | BCH-2508-A7959 | Medutest | 2025-Q3 | 99.55 | 4.74 | 95.4 | Buyer-sourced | 0 | PASS |
| AX-2025-021335 | BCH-2508-A7959 | Janoshik | 2025-Q3 | 98.62 | 5.27 | 90.4 | Buyer-sourced | 0 | PASS |
| AX-2025-021336 | BCH-2508-A7959 | VendorInvestigate | 2025-Q3 | 98.98 | 5.19 | 94.3 | Buyer-sourced | 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 |