AX-2024-004944
Semaglutide · 2 mg declared · Shanghai ERP Biotechnology Co., Ltd. · lot ERP-2404-Y7646
MARGINALVERIFIED
- Report ID
- AX-2024-004944
- Compound
- Semaglutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- ERP — Shanghai ERP Biotechnology Co., Ltd.
- Batch / lot
- ERP-2404-Y7646
- Declared label claim
- 2mg
- Laboratory
- VendorInvestigate
- Assay date
- 23 Sep 2024
- Submitted
- 24 Sep 2024
- Quarter
- 2024-Q3
- Submitter
- r.cabrera
- 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, 32 min gradient, 214 nm | 97.95 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 2.05 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — des-AEEA semaglutide (−145 Da) | 0.92 | % 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) | 4111.0376 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -3.6 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 89.04 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 87.21 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 2.44 | mg | 2 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 2.128 | mg | 2 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 106.4 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 3.41 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 6.80 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.75 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 1.11 | 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 | 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 | 3.53 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 32 min gradient | 19.57 | min | 19.55 ± 0.45 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.04 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 75,078 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib8]-diastereomer | 0.87 | — | 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 | 19.57 | 4,760,674 | 97.95 | — |
| 2 | des-AEEA semaglutide (−145 Da) | 18.70 | 44,715 | 0.92 | -145.074 |
| 3 | C18 diacid mono-ester | 21.02 | 22,843 | 0.47 | +14.016 |
| 4 | [D-Aib8]-diastereomer | 19.31 | 21,385 | 0.44 | 0.000 |
| 5 | deamidated (Asn→Asp, +1 Da) | 19.03 | 7,290 | 0.15 | +0.984 |
| 6 | tBu-protected residual (+56 Da) | 21.76 | 1,944 | 0.04 | +56.063 |
| 7 | des-His1 truncate (−137 Da) | 18.35 | 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 | 686.1802 | -0.0025 | 8.9 |
| 5+ | 823.2178 | 823.2148 | -0.0030 | 52.9 |
| 4+ | 1028.7704 | 1028.7667 | -0.0037 | 100.0 |
| 3+ | 1371.3581 | 1371.3531 | -0.0050 | 55.7 |
| 2+ | 2056.5335 | 2056.5261 | -0.0074 | 8.4 |
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 | 3.41 |
| Counter-ion (TFA) | ion chromatography | 6.80 |
| Residual solvent + inorganic residue | estimated | 0.75 |
| Total peptide content | by difference | 89.04 |
| 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) | 99.04 | 97.95 | divergence +0.25 pp vs batch median |
| Total impurities (% area) | 0.96 | 2.05 | |
| Largest single impurity (% area) | not stated | 0.92 | |
| Water (%) | not stated | 3.41 | |
| Counter-ion (%) | not stated | 6.80 | |
| Peptide content (%w/w) | not stated | 89.04 | |
| Endotoxin (EU/mg) | not stated | 1.11 | |
| 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, 11 d) → laboratory (courier, cold pack, 9 d) → assay.
- Assay date
- 23 Sep 2024
- Submitted to the index
- 24 Sep 2024
- Laboratory
- VendorInvestigate, Riga, Latvia
- Method basis
- 32 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 ERP-2404-Y7646 n=15
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-004940 | ERP-2404-Y7646 | PeptideMeter | 2024-Q3 | 99.29 | 4.02 | — | Supplier-supplied | 3 | MARGINAL |
| AX-2024-004941 | ERP-2404-Y7646 | Janoshik | 2024-Q3 | 98.68 | 3.26 | 100.6 | Supplier-supplied | 3 | MARGINAL |
| AX-2024-004942 | ERP-2404-Y7646 | Janoshik | 2024-Q3 | 98.79 | 4.18 | 100.6 | Supplier-supplied | 3 | MARGINAL |
| AX-2024-004943 | ERP-2404-Y7646 | VendorInvestigate | 2024-Q3 | 97.88 | 3.34 | 107.2 | Buyer-sourced | 2 | MARGINAL |
| AX-2024-004945 | ERP-2404-Y7646 | Janoshik | 2024-Q3 | 97.96 | 3.70 | 102.9 | Buyer-sourced | 2 | MARGINAL |
| AX-2024-004946 | ERP-2404-Y7646 | Janoshik | 2024-Q3 | 99.08 | 3.87 | 101.4 | Supplier-supplied | 3 | MARGINAL |
| AX-2024-004947 | ERP-2404-Y7646 | PeptideMeter | 2024-Q3 | 98.78 | 3.39 | 96.9 | Supplier-supplied | 3 | MARGINAL |
| AX-2024-004948 | ERP-2404-Y7646 | PeptideMeter | 2024-Q3 | 98.81 | 3.37 | 104.8 | Supplier-supplied | 3 | MARGINAL |
| AX-2024-004949 | ERP-2404-Y7646 | PeptideMeter | 2024-Q3 | 98.85 | 3.65 | 101.9 | Supplier-supplied | 3 | MARGINAL |
| AX-2024-004950 | ERP-2404-Y7646 | Medutest | 2024-Q3 | 99.30 | 2.65 | — | Supplier-supplied | 3 | MARGINAL |
| AX-2024-004951 | ERP-2404-Y7646 | Nordanalyt | 2024-Q3 | 98.07 | 3.37 | — | Supplier-supplied | 3 | MARGINAL |
| AX-2024-004952 | ERP-2404-Y7646 | Medutest | 2024-Q3 | 99.51 | 4.12 | — | Supplier-supplied | 3 | MARGINAL |
| AX-2024-004953 | ERP-2404-Y7646 | Medutest | 2024-Q3 | 98.80 | 3.53 | 94.9 | Supplier-supplied | 3 | MARGINAL |
| AX-2024-004954 | ERP-2404-Y7646 | PeptideMeter | 2024-Q3 | 98.75 | 3.92 | — | Supplier-supplied | 3 | MARGINAL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041334 | WWB | WWB-2606-N3192 | Janoshik | 2026-Q3 | 98.83 | 5.04 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041932 | TFC | TFC-2604-X4301 | Janoshik | 2026-Q3 | 98.88 | 4.31 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042347 | HJ | HJ-2608-C3931 | VendorInvestigate | 2026-Q3 | 98.80 | 3.41 | 100.2 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041886 | JEEP | JEEP-2607-X3911 | Nordanalyt | 2026-Q3 | 99.19 | 4.03 | 96.4 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041337 | WWB | WWB-2606-N3192 | Nordanalyt | 2026-Q3 | 98.96 | 4.81 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042172 | Homopeptide | HOMO-2604-X8921 | Janoshik | 2026-Q3 | 99.64 | 5.16 | 91.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041767 | FGP | FGP-2602-M1508 | PeptideMeter | 2026-Q3 | 98.65 | 2.54 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-041882 | JEEP | JEEP-2607-X3911 | Nordanalyt | 2026-Q3 | 99.17 | 4.52 | — | Supplier-supplied | 1 | MARGINAL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042574 | TB-500 | ERP-2605-S8022 | VendorInvestigate | 2026-Q3 | 99.54 | 2.91 | 96.4 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042535 | Tesamorelin | ERP-2604-W7280 | Janoshik | 2026-Q3 | 99.19 | 3.89 | 92.7 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042577 | TB-500 | ERP-2605-S8022 | Janoshik | 2026-Q3 | 99.51 | 3.45 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042542 | Tesamorelin | ERP-2604-W7280 | Janoshik | 2026-Q3 | 98.54 | 4.58 | 103.1 | Supplier-supplied | 2 | FAIL |
| AX-2026-042547 | Survodutide | ERP-2605-E7682 | PeptideMeter | 2026-Q3 | 98.25 | 5.44 | 93.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042540 | Tesamorelin | ERP-2604-W7280 | Kestrel | 2026-Q3 | 99.72 | 3.47 | 103.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042575 | TB-500 | ERP-2605-S8022 | Janoshik | 2026-Q3 | 99.93 | 3.36 | 95.5 | Supplier-supplied | 0 | PASS |
| AX-2026-042539 | Tesamorelin | ERP-2604-W7280 | Janoshik | 2026-Q3 | 98.77 | 4.30 | 89.9 | Buyer-sourced | 2 | MARGINAL |