AX-2026-043383
Semaglutide · 2 mg declared · Chinese Peptide Company Co., Ltd. · lot CPC-2605-U3098
- Report ID
- AX-2026-043383
- Compound
- Semaglutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- CPC — Chinese Peptide Company Co., Ltd.
- Batch / lot
- CPC-2605-U3098
- Declared label claim
- 2mg
- Laboratory
- PeptideMeter
- Assay date
- 02 Aug 2026
- Submitted
- 19 Aug 2026
- Quarter
- 2026-Q3
- Submitter
- Contributor #A-7284
- Sample provenance
- Supplier-supplied
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 | 97.63 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 2.37 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — deamidated (Asn→Asp, +1 Da) | 1.43 | % area | ≤ 1.00 | FAIL |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 84.96 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 82.95 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 2.28 | mg | 2 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 1.891 | mg | 2 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 94.6 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.29 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 10.60 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.15 | % | — | 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 lyophilised cake, intact | — | white to off-white intact cake | PASS |
| Reconstitution clarity | reconstituted per submitter procedure | Faint haze, clearing on standing | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 3.50 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 17.12 | min | 17.29 ± 0.45 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.21 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 34,746 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib8]-diastereomer | 0.59 | — | no index criterion | REPORTED |
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 | 17.12 | 4,745,121 | 97.63 | — |
| 2 | deamidated (Asn→Asp, +1 Da) | 16.64 | 69,502 | 1.43 | +0.984 |
| 3 | [D-Aib8]-diastereomer | 16.90 | 31,592 | 0.65 | 0.000 |
| 4 | Met(O) sulfoxide (+16 Da) | 16.49 | 7,776 | 0.16 | +15.995 |
| 5 | tBu-protected residual (+56 Da) | 19.03 | 3,402 | 0.07 | +56.063 |
| 6 | des-AEEA semaglutide (−145 Da) | 16.35 | 1,944 | 0.04 | -145.074 |
| 7 | C18 diacid mono-ester | 18.39 | 972 | 0.02 | +14.016 |
| 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.
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 | 4.29 |
| Counter-ion (TFA) | ion chromatography | 10.60 |
| Residual solvent + inorganic residue | estimated | 0.15 |
| Total peptide content | by difference | 84.96 |
| 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) | 98.5 | 97.63 | divergence +0.82 pp vs batch median |
| Total impurities (% area) | 1.50 | 2.37 | |
| Largest single impurity (% area) | 0.68 | 1.43 | |
| Water (%) | 4.2 | 4.29 | |
| Counter-ion (%) | not stated | 10.60 | |
| Peptide content (%w/w) | not stated | 84.96 | |
| Endotoxin (EU/mg) | not stated | not determined | |
| Method stated on certificate | YES | — | column, gradient and wavelength given |
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
- Supplier-supplied
- Evidentiary weight
- Weaker evidence. Read with the caveat below.
- Chain of custody
- Supplier despatch → laboratory direct (courier, cold pack, 3 d) → assay. Submitter did not handle the vial.
- Assay date
- 02 Aug 2026
- Submitted to the index
- 19 Aug 2026
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot CPC-2605-U3098 n=3
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043381 | CPC-2605-U3098 | PeptideMeter | 2026-Q3 | 97.74 | 4.91 | 93.2 | Buyer-sourced | 2 | MARGINAL |
| AX-2026-043382 | CPC-2605-U3098 | VendorInvestigate | 2026-Q3 | 97.68 | 4.35 | 107.3 | Laboratory-retained | 2 | 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-2026-043368 | N-Acetyl Semax Amide | CPC-2602-D2941 | Medutest | 2026-Q3 | 98.79 | 6.05 | 102.1 | Supplier-supplied | 0 | PASS |
| AX-2026-043335 | Liraglutide | CPC-2602-G1978 | Janoshik | 2026-Q3 | 97.29 | 4.91 | — | Laboratory-retained | 1 | FAIL |
| AX-2026-043283 | L-Carnosine | CPC-2603-G1651 | Medutest | 2026-Q3 | 98.10 | 10.12 | 91.8 | Supplier-supplied | 1 | FAIL |
| AX-2026-043365 | BPC-157 | CPC-2602-W2646 | Medutest | 2026-Q3 | 98.56 | 2.80 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043332 | Liraglutide | CPC-2602-G1978 | Janoshik | 2026-Q3 | 97.16 | 4.88 | 91.3 | Supplier-supplied | 1 | FAIL |
| AX-2026-043289 | L-Carnosine | CPC-2603-G1651 | Janoshik | 2026-Q3 | 98.01 | 10.52 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-043287 | L-Carnosine | CPC-2603-G1651 | Janoshik | 2026-Q3 | 98.35 | 9.89 | 93.2 | Supplier-supplied | 2 | FAIL |
| AX-2026-043367 | N-Acetyl Semax Amide | CPC-2602-D2941 | Nordanalyt | 2026-Q3 | 99.39 | 6.16 | 92.4 | Supplier-supplied | 0 | PASS |