Where two laboratories tested the same retail lot, the paired difference is a clean estimate of inter-lab bias with no selection term in it at all. Those pairs are the backbone of the agreement analysis.
AX-2024-005592
Semaglutide · 15 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2401-C8154
PASSPURITY ONLY
- Report ID
- AX-2024-005592
- Compound
- Semaglutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- BCH — Bachem Holding (Suzhou) Co., Ltd.
- Batch / lot
- BCH-2401-C8154
- Declared label claim
- 15mg
- Laboratory
- Janoshik Analytical
- Assay date
- 22 Apr 2024
- Submitted
- 11 May 2024
- Quarter
- 2024-Q2
- Submitter
- jo.vasquez
- 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 | 98.69 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.31 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — [D-Aib8]-diastereomer | 0.87 | % 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 | 6.21 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 7.62 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.72 | % | — | 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 | 4.84 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 18.44 | min | 18.42 ± 0.45 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.93 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 48,668 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib8]-diastereomer | 0.70 | — | 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 | Semaglutide — main peak | 18.44 | 4,796,640 | 98.69 | — |
| 2 | [D-Aib8]-diastereomer | 18.20 | 42,285 | 0.87 | 0.000 |
| 3 | semaglutide dimer | 22.15 | 14,581 | 0.30 | +4111.052 |
| 4 | Met(O) sulfoxide (+16 Da) | 17.76 | 4,374 | 0.09 | +15.995 |
| 5 | des-AEEA semaglutide (−145 Da) | 17.62 | 1,458 | 0.03 | -145.074 |
| 6 | C18 diacid mono-ester | 19.80 | 486 | 0.01 | +14.016 |
| 7 | deamidated (Asn→Asp, +1 Da) | 17.93 | 486 | 0.01 | +0.984 |
| 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) | 97.90 | 98.69 | divergence -0.36 pp vs batch median |
| Total impurities (% area) | 2.10 | 1.31 | |
| Largest single impurity (% area) | not stated | 0.87 | |
| Water (%) | not stated | 6.21 | |
| Counter-ion (%) | 7.6 | 7.62 | |
| Peptide content (%w/w) | 97.7 | 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 → submitter (−20 °C, 26 d) → laboratory (courier, dry ice, 10 d) → assay.
- Assay date
- 22 Apr 2024
- Submitted to the index
- 11 May 2024
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-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.
The document that arrived with this order is on file and its fields are scored on the supplier's documentation rubric. That score describes what a buyer receives, which is the useful version.
Section 7
Related records
Same batch — lot BCH-2401-C8154 n=16
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-005586 | BCH-2401-C8154 | VendorInvestigate | 2024-Q2 | 98.27 | 5.30 | — | Buyer-sourced | 0 | PASS |
| AX-2024-005587 | BCH-2401-C8154 | Janoshik | 2024-Q2 | 98.02 | 5.87 | 99.0 | Buyer-sourced | 0 | PASS |
| AX-2024-005588 | BCH-2401-C8154 | Janoshik | 2024-Q2 | 98.10 | 6.19 | 97.8 | Buyer-sourced | 0 | PASS |
| AX-2024-005589 | BCH-2401-C8154 | Medutest | 2024-Q2 | 97.68 | 5.84 | 98.1 | Buyer-sourced | 0 | PASS |
| AX-2024-005590 | BCH-2401-C8154 | PeptideMeter | 2024-Q2 | 98.56 | 5.60 | — | Buyer-sourced | 0 | PASS |
| AX-2024-005591 | BCH-2401-C8154 | Janoshik | 2024-Q2 | 98.68 | 5.70 | 95.2 | Supplier-supplied | 0 | PASS |
| AX-2024-005593 | BCH-2401-C8154 | Kestrel | 2024-Q2 | 99.56 | 5.41 | 94.7 | Buyer-sourced | 0 | PASS |
| AX-2024-005594 | BCH-2401-C8154 | Janoshik | 2024-Q2 | 98.72 | 5.75 | 103.5 | Supplier-supplied | 0 | PASS |
| AX-2024-005595 | BCH-2401-C8154 | PeptideMeter | 2024-Q2 | 98.30 | 5.87 | — | Buyer-sourced | 0 | PASS |
| AX-2024-005596 | BCH-2401-C8154 | Janoshik | 2024-Q2 | 97.67 | 5.97 | 103.6 | Buyer-sourced | 1 | MARGINAL |
| AX-2024-005597 | BCH-2401-C8154 | Janoshik | 2024-Q2 | 98.77 | 5.90 | 97.7 | Supplier-supplied | 0 | PASS |
| AX-2024-005598 | BCH-2401-C8154 | Janoshik | 2024-Q2 | 98.22 | 5.22 | 90.5 | Supplier-supplied | 0 | PASS |
| AX-2024-005599 | BCH-2401-C8154 | Medutest | 2024-Q2 | 98.15 | 5.65 | 106.1 | Buyer-sourced | 0 | PASS |
| AX-2024-005600 | BCH-2401-C8154 | Janoshik | 2024-Q2 | 98.09 | 5.47 | 102.9 | Buyer-sourced | 0 | PASS |
| AX-2024-005601 | BCH-2401-C8154 | Janoshik | 2024-Q2 | 98.25 | 5.86 | 100.2 | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042336 | Homopeptide | HOMO-2604-X1993 | Nordanalyt | 2026-Q3 | 98.87 | 4.67 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041764 | FGP | FGP-2602-M9916 | Janoshik | 2026-Q3 | 99.37 | 2.78 | 101.1 | Buyer-sourced | 0 | PASS |
| AX-2026-042534 | HJ | HJ-2608-C5744 | Janoshik | 2026-Q3 | 99.08 | 3.52 | 95.5 | Buyer-sourced | 0 | PASS |
| AX-2026-042529 | HJ | HJ-2608-C5744 | Nordanalyt | 2026-Q3 | 99.38 | 3.55 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042602 | SWB | SWB-2602-X6980 | Janoshik | 2026-Q3 | 98.77 | 4.03 | 95.3 | Supplier-supplied | 0 | PASS |
| AX-2026-041334 | WWB | WWB-2606-N3192 | Janoshik | 2026-Q3 | 98.93 | 4.62 | 99.9 | Buyer-sourced | 0 | PASS |
| AX-2026-041761 | FGP | FGP-2602-M9916 | Janoshik | 2026-Q3 | 99.27 | 1.98 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043345 | GL Biochem | GLBI-2602-U9408 | Janoshik | 2026-Q3 | 97.06 | 6.05 | 95.1 | 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 |