A closed balance is what converts a purity figure into a mass. 82.60 %w/w target content on a 15 mg claim gives 14.91 mg recovered, and every step of that is on the record.
AX-2025-019734
Semaglutide · 15 mg declared · Hunan Aslsen Technology Co., Ltd. · lot HOMO-2505-V3835
PASSPURITY ONLY
- Report ID
- AX-2025-019734
- Compound
- Semaglutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- Homopeptide — Hunan Aslsen Technology Co., Ltd.
- Batch / lot
- HOMO-2505-V3835
- Declared label claim
- 15mg
- Laboratory
- PeptideMeter
- Assay date
- 31 Jul 2025
- Submitted
- 22 Aug 2025
- Quarter
- 2025-Q3
- Submitter
- l.norgaard
- 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 | 98.50 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.50 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — [D-Aib8]-diastereomer | 0.55 | % 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 | 83.86 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 82.60 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 18.05 | mg | 15 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 14.909 | mg | 15 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 99.4 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.13 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 9.63 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.38 | % | — | 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 | White cake, partially collapsed | — | 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 | 5.55 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 17.41 | min | 17.29 ± 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 | 48,216 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib8]-diastereomer | 0.69 | — | 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 | 17.41 | 4,787,405 | 98.50 | — |
| 2 | [D-Aib8]-diastereomer | 17.19 | 26,732 | 0.55 | 0.000 |
| 3 | Met(O) sulfoxide (+16 Da) | 16.78 | 22,843 | 0.47 | +15.995 |
| 4 | des-AEEA semaglutide (−145 Da) | 16.64 | 12,637 | 0.26 | -145.074 |
| 5 | semaglutide dimer | 20.87 | 6,804 | 0.14 | +4111.052 |
| 6 | des-His1 truncate (−137 Da) | 16.35 | 1,944 | 0.04 | -137.059 |
| 7 | tBu-protected residual (+56 Da) | 19.32 | 1,944 | 0.04 | +56.063 |
| 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 | 6.13 |
| Counter-ion (TFA) | ion chromatography | 9.63 |
| Residual solvent + inorganic residue | estimated | 0.38 |
| Total peptide content | by difference | 83.86 |
| 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) | 99.37 | 98.50 | divergence +0.82 pp vs batch median |
| Total impurities (% area) | 0.63 | 1.50 | |
| Largest single impurity (% area) | not stated | 0.55 | |
| Water (%) | 4.1 | 6.13 | |
| Counter-ion (%) | not stated | 9.63 | |
| Peptide content (%w/w) | not stated | 83.86 | |
| Endotoxin (EU/mg) | not stated | not determined | |
| Method stated on certificate | NO | — | no method section — the result cannot be reconciled against any other |
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 (2–8 °C, 18 d) → laboratory (courier, ambient, 5 d) → assay.
- Assay date
- 31 Jul 2025
- Submitted to the index
- 22 Aug 2025
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
Section 6
Annotations 1
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.
Section 7
Related records
Same batch — lot HOMO-2505-V3835 n=14
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-019726 | HOMO-2505-V3835 | Nordanalyt | 2025-Q3 | 98.37 | 6.12 | 97.9 | Buyer-sourced | 0 | PASS |
| AX-2025-019727 | HOMO-2505-V3835 | PeptideMeter | 2025-Q3 | 98.44 | 5.98 | — | Laboratory-retained | 0 | PASS |
| AX-2025-019728 | HOMO-2505-V3835 | PeptideMeter | 2025-Q3 | 98.80 | 6.81 | 106.3 | Buyer-sourced | 0 | PASS |
| AX-2025-019729 | HOMO-2505-V3835 | PeptideMeter | 2025-Q3 | 97.84 | 6.27 | — | Buyer-sourced | 0 | PASS |
| AX-2025-019730 | HOMO-2505-V3835 | Kestrel | 2025-Q3 | 99.18 | 6.39 | — | Buyer-sourced | 0 | PASS |
| AX-2025-019731 | HOMO-2505-V3835 | Medutest | 2025-Q3 | 98.75 | 6.56 | 88.5 | Buyer-sourced | 2 | FAIL |
| AX-2025-019732 | HOMO-2505-V3835 | Janoshik | 2025-Q3 | 98.95 | 6.80 | — | Buyer-sourced | 0 | PASS |
| AX-2025-019733 | HOMO-2505-V3835 | VendorInvestigate | 2025-Q3 | 98.02 | 6.04 | — | Buyer-sourced | 0 | PASS |
| AX-2025-019735 | HOMO-2505-V3835 | Janoshik | 2025-Q3 | 98.60 | 6.41 | — | Buyer-sourced | 0 | PASS |
| AX-2025-019736 | HOMO-2505-V3835 | Janoshik | 2025-Q3 | 98.31 | 6.14 | 91.4 | Buyer-sourced | 0 | PASS |
| AX-2025-019737 | HOMO-2505-V3835 | PeptideMeter | 2025-Q3 | 98.61 | 6.29 | — | Laboratory-retained | 0 | PASS |
| AX-2025-019738 | HOMO-2505-V3835 | VendorInvestigate | 2025-Q3 | 98.85 | 6.12 | — | Laboratory-retained | 0 | PASS |
| AX-2025-019739 | HOMO-2505-V3835 | Janoshik | 2025-Q3 | 98.26 | 5.86 | — | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043376 | WXT | WXT-2604-C3248 | Janoshik | 2026-Q3 | 97.08 | 4.22 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042424 | Homopeptide | HOMO-2604-X3806 | PeptideMeter | 2026-Q3 | 98.85 | 4.87 | 92.0 | Buyer-sourced | 0 | PASS |
| AX-2026-041643 | FGP | FGP-2602-M8547 | Janoshik | 2026-Q3 | 99.31 | 2.79 | 100.7 | Buyer-sourced | 0 | PASS |
| AX-2026-041334 | WWB | WWB-2606-N3192 | Janoshik | 2026-Q3 | 98.93 | 4.62 | 99.9 | Buyer-sourced | 0 | PASS |
| AX-2026-042002 | AMB | AMB-2607-N6274 | VendorInvestigate | 2026-Q3 | 98.23 | 6.37 | 97.1 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041337 | WWB | WWB-2606-N3192 | Nordanalyt | 2026-Q3 | 99.52 | 3.92 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042595 | HJ | HJ-2608-C7002 | Janoshik | 2026-Q3 | 99.50 | 3.55 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042217 | TFC | TFC-2604-X9037 | PeptideMeter | 2026-Q3 | 98.95 | 4.61 | 96.9 | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042437 | Retatrutide | HOMO-2605-V4718 | Nordanalyt | 2026-Q3 | 98.68 | 3.67 | 102.8 | Buyer-sourced | 0 | PASS |
| AX-2026-042424 | Semaglutide | HOMO-2604-X3806 | PeptideMeter | 2026-Q3 | 98.85 | 4.87 | 92.0 | Buyer-sourced | 0 | PASS |
| AX-2026-042503 | IGF-1 LR3 | HOMO-2607-P5131 | Janoshik | 2026-Q3 | 99.36 | 5.99 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042492 | SS-31 (Elamipretide) | HOMO-2604-D5484 | Medutest | 2026-Q3 | 99.93 | 2.40 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042491 | SS-31 (Elamipretide) | HOMO-2604-D5484 | Kestrel | 2026-Q3 | 99.93 | 3.24 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042473 | LL-37 | HOMO-2602-G5165 | Janoshik | 2026-Q3 | 99.01 | 5.00 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042441 | Retatrutide | HOMO-2605-V4718 | Medutest | 2026-Q3 | 98.93 | 4.22 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042474 | LL-37 | HOMO-2602-G5165 | Janoshik | 2026-Q3 | 99.18 | 5.44 | — | Buyer-sourced | 0 | PASS |