Well inside class limit. Worth noting that the class limits are set by mass rather than globally, because the same ppm is a different number of daltons at 340 and at 4,800.
AX-2024-005595
Semaglutide · 15 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2401-C8154
PASSVERIFIED
- Report ID
- AX-2024-005595
- 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
- PeptideMeter
- Assay date
- 19 Apr 2024
- Submitted
- 22 Apr 2024
- Quarter
- 2024-Q2
- Submitter
- import_hold
- 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, 28 min gradient, 214 nm | 98.30 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.70 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — des-AEEA semaglutide (−145 Da) | 0.80 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 4111.0524 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 4111.0619 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +2.3 | ppm | ± 15 | PASS |
| Peptide content | not ordered on this submission | not determined | — | required to check label claim | NOT TESTED |
| Water content | Karl Fischer, coulometric, duplicate | 5.87 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 9.29 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.36 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.88 | 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 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 | 3.19 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 17.30 | min | 17.29 ± 0.45 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.01 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 89,423 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib8]-diastereomer | 0.94 | — | 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 | 17.30 | 4,777,685 | 98.30 | — |
| 2 | des-AEEA semaglutide (−145 Da) | 16.53 | 38,882 | 0.80 | -145.074 |
| 3 | deamidated (Asn→Asp, +1 Da) | 16.82 | 28,676 | 0.59 | +0.984 |
| 4 | [D-Aib8]-diastereomer | 17.08 | 8,263 | 0.17 | 0.000 |
| 5 | C18 diacid mono-ester | 18.57 | 3,402 | 0.07 | +14.016 |
| 6 | Met(O) sulfoxide (+16 Da) | 16.67 | 1,944 | 0.04 | +15.995 |
| 7 | des-His1 truncate (−137 Da) | 16.24 | 1,458 | 0.03 | -137.059 |
| 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 4111.0524 Da, computed from C187H291N45O59. 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 (%) |
|---|---|---|---|---|
| 6+ | 686.1827 | 686.1843 | 0.0016 | 8.4 |
| 5+ | 823.2178 | 823.2197 | 0.0019 | 53.2 |
| 4+ | 1028.7704 | 1028.7728 | 0.0024 | 100.0 |
| 3+ | 1371.3581 | 1371.3612 | 0.0031 | 58.2 |
| 2+ | 2056.5335 | 2056.5382 | 0.0047 | 8.7 |
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 | 98.30 | divergence -0.36 pp vs batch median |
| Total impurities (% area) | 2.10 | 1.70 | |
| Largest single impurity (% area) | not stated | 0.80 | |
| Water (%) | not stated | 5.87 | |
| Counter-ion (%) | 7.6 | 9.29 | |
| Peptide content (%w/w) | 97.7 | not determined | |
| Endotoxin (EU/mg) | not stated | 0.88 | |
| 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, 20 d) → laboratory (hand-carried, 9 d) → assay.
- Assay date
- 19 Apr 2024
- Submitted to the index
- 22 Apr 2024
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- VERIFIED
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.
Instrument was evidently in calibration on the day. A run of results at this accuracy across a laboratory's sequence is the background against which an excursion becomes interpretable.
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-2024-005592 | BCH-2401-C8154 | Janoshik | 2024-Q2 | 98.69 | 6.21 | — | Buyer-sourced | 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-2024-005596 | 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 |