Lot KP-2405-C4939 on this sample can be checked against retail stock by anyone who buys one. That is a concrete, cheap piece of work and it would resolve the provenance question for this lot outright.
AX-2024-005002
Semaglutide · 2 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2405-C4939
PASSPURITY ONLY
- Report ID
- AX-2024-005002
- Compound
- Semaglutide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- KP — Zhuhai Kerui Biotechnology Co., Ltd.
- Batch / lot
- KP-2405-C4939
- Declared label claim
- 2mg
- Laboratory
- Janoshik Analytical
- Assay date
- 20 Sep 2024
- Submitted
- 14 Oct 2024
- Quarter
- 2024-Q3
- Submitter
- csv_parser
- Sample provenance
- Supplier-supplied
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 | 98.51 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.49 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — [D-Aib8]-diastereomer | 1.07 | % 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 | 84.50 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 83.24 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 2.21 | mg | 2 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 1.840 | mg | 2 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 92.0 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.26 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 10.08 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.16 | % | — | NOT TESTED |
| Endotoxin | not ordered on this submission | not determined | — | ≤ 5.0 | NOT TESTED |
| Sterility | membrane filtration, USP <71>, 14 d | No growth at 14 d | — | no growth | PASS |
| 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 | 3.57 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 18.69 | min | 18.42 ± 0.45 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.09 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 69,241 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib8]-diastereomer | 0.82 | — | 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 | 18.69 | 4,787,891 | 98.51 | — |
| 2 | [D-Aib8]-diastereomer | 18.45 | 52,005 | 1.07 | 0.000 |
| 3 | des-AEEA semaglutide (−145 Da) | 17.87 | 9,235 | 0.19 | -145.074 |
| 4 | deamidated (Asn→Asp, +1 Da) | 18.18 | 6,804 | 0.14 | +0.984 |
| 5 | des-His1 truncate (−137 Da) | 17.55 | 1,944 | 0.04 | -137.059 |
| 6 | semaglutide dimer | 22.40 | 1,458 | 0.03 | +4111.052 |
| 7 | C18 diacid mono-ester | 20.05 | 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.
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 | 5.26 |
| Counter-ion (TFA) | ion chromatography | 10.08 |
| Residual solvent + inorganic residue | estimated | 0.16 |
| Total peptide content | by difference | 84.50 |
| 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) | 98.18 | 98.51 | divergence +0.16 pp vs batch median |
| Total impurities (% area) | not stated | 1.49 | |
| Largest single impurity (% area) | not stated | 1.07 | |
| Water (%) | 2.5 | 5.26 | |
| Counter-ion (%) | not stated | 10.08 | |
| Peptide content (%w/w) | not stated | 84.50 | |
| Endotoxin (EU/mg) | 0.16 | 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
- Supplier-supplied
- Evidentiary weight
- Weaker evidence. Read with the caveat below.
- Chain of custody
- Supplier despatch → laboratory direct (courier, cold pack, 4 d) → assay. Submitter did not handle the vial.
- Assay date
- 20 Sep 2024
- Submitted to the index
- 14 Oct 2024
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 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 KP-2405-C4939 n=15
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-005001 | KP-2405-C4939 | Janoshik | 2024-Q3 | 98.02 | 5.06 | 88.5 | Buyer-sourced | 1 | MARGINAL |
| AX-2024-005003 | KP-2405-C4939 | Janoshik | 2024-Q3 | 97.95 | 4.71 | 90.9 | Buyer-sourced | 0 | PASS |
| AX-2024-005004 | KP-2405-C4939 | Janoshik | 2024-Q3 | 98.01 | 4.67 | — | Buyer-sourced | 0 | PASS |
| AX-2024-005005 | KP-2405-C4939 | Janoshik | 2024-Q3 | 98.22 | 5.17 | — | Buyer-sourced | 0 | PASS |
| AX-2024-005006 | KP-2405-C4939 | Janoshik | 2024-Q3 | 98.01 | 4.35 | — | Buyer-sourced | 0 | PASS |
| AX-2024-005007 | KP-2405-C4939 | Janoshik | 2024-Q3 | 97.90 | 4.69 | — | Buyer-sourced | 0 | PASS |
| AX-2024-005008 | KP-2405-C4939 | VendorInvestigate | 2024-Q3 | 98.06 | 4.26 | 106.1 | Buyer-sourced | 0 | PASS |
| AX-2024-005009 | KP-2405-C4939 | Janoshik | 2024-Q3 | 97.51 | 5.21 | 96.5 | Buyer-sourced | 0 | PASS |
| AX-2024-005010 | KP-2405-C4939 | Medutest | 2024-Q3 | 98.70 | 4.51 | 95.1 | Supplier-supplied | 0 | PASS |
| AX-2024-005011 | KP-2405-C4939 | Janoshik | 2024-Q3 | 97.65 | 4.85 | 104.7 | Buyer-sourced | 0 | PASS |
| AX-2024-005012 | KP-2405-C4939 | Nordanalyt | 2024-Q3 | 98.28 | 5.51 | — | Laboratory-retained | 0 | PASS |
| AX-2024-005013 | KP-2405-C4939 | Janoshik | 2024-Q3 | 97.66 | 5.37 | 97.6 | Buyer-sourced | 0 | PASS |
| AX-2024-005014 | KP-2405-C4939 | Medutest | 2024-Q3 | 98.31 | 4.90 | 99.4 | Buyer-sourced | 0 | PASS |
| AX-2024-005015 | KP-2405-C4939 | Medutest | 2024-Q3 | 98.02 | 5.08 | 88.9 | Buyer-sourced | 1 | MARGINAL |
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-2026-043095 | Retatrutide | KP-2607-H5774 | Janoshik | 2026-Q3 | 95.81 | 5.48 | 105.2 | Buyer-sourced | 0 | FAIL |
| AX-2026-043094 | Retatrutide | KP-2607-H5774 | PeptideMeter | 2026-Q3 | 96.32 | 6.40 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043096 | Retatrutide | KP-2607-H5774 | VendorInvestigate | 2026-Q3 | 96.48 | 6.05 | 104.9 | Buyer-sourced | 0 | FAIL |
| AX-2026-043090 | Retatrutide | KP-2607-H5774 | Janoshik | 2026-Q3 | 96.46 | 5.81 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043091 | Retatrutide | KP-2607-H5774 | Janoshik | 2026-Q3 | 96.13 | 5.94 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043077 | TB-500 | KP-2605-C5214 | Janoshik | 2026-Q2 | 99.61 | 5.64 | 90.2 | Buyer-sourced | 0 | PASS |
| AX-2026-043093 | Retatrutide | KP-2607-H5774 | Janoshik | 2026-Q3 | 96.54 | 5.54 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043092 | Retatrutide | KP-2607-H5774 | Medutest | 2026-Q3 | 96.64 | 6.12 | — | Buyer-sourced | 1 | FAIL |