AX-2026-042970
5-Amino-1MQ · 50 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2511-W4792
- Report ID
- AX-2026-042970
- Compound
- 5-Amino-1MQ
- Compound class
- Non-peptide adjuncts
- Supplier
- KP — Zhuhai Kerui Biotechnology Co., Ltd.
- Batch / lot
- KP-2511-W4792
- Declared label claim
- 50mg
- Laboratory
- Janoshik Analytical
- Assay date
- 25 May 2026
- Submitted
- 02 Jun 2026
- Quarter
- 2026-Q2
- Submitter
- e.nwosu
- Sample provenance
- Supplier-supplied
Results
Measured against the index acceptance specification for the non-peptide adjuncts 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 | 98.89 | % area | ≥ 98.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.11 | % area | ≤ 2.0 | PASS |
| Largest single impurity | RP-HPLC — 1-methylquinolinium (des-amino, −15 Da) | 0.77 | % 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 | 50.55 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 49.99 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 90.97 | mg | 50 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 45.476 | mg | 50 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 91.0 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.03 | % | ≤ 10.0 | PASS |
| Counter-ion (iodide) | anion-exchange ion chromatography | 45.13 | % | ≤ 12.0 | FAIL |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.29 | % | — | 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 | Clear, colourless, no visible particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 5.15 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 5.30 | min | 5.42 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.07 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 40,667 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs free iodide (counter-ion, by IC) | 0.00 | — | 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 | 5-Amino-1MQ — main peak | 5.30 | 4,806,361 | 98.89 | — |
| 2 | 1-methylquinolinium (des-amino, −15 Da) | 4.98 | 37,424 | 0.77 | -15.011 |
| 3 | 8-amino regioisomer | 5.52 | 9,721 | 0.20 | 0.000 |
| 4 | 5-nitro-1MQ (unreduced precursor, +30 Da) | 5.98 | 3,402 | 0.07 | +29.974 |
| 5 | free iodide (counter-ion, by IC) | 5.30 | 3,402 | 0.07 | 0.000 |
| 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 | 4.03 |
| Counter-ion (iodide) | ion chromatography | 45.13 |
| Residual solvent + inorganic residue | estimated | 0.29 |
| Total peptide content | by difference | 50.55 |
| 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) | 99.0 | 98.89 | divergence -0.33 pp vs batch median |
| Total impurities (% area) | 1.00 | 1.11 | |
| Largest single impurity (% area) | 0.68 | 0.77 | |
| Water (%) | 2.0 | 4.03 | |
| Counter-ion (%) | not stated | 45.13 | |
| Peptide content (%w/w) | not stated | 50.55 | |
| Endotoxin (EU/mg) | not stated | not determined | |
| Method stated on certificate | NO | — | no method section — the result cannot be reconciled against any other |
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, 10 d) → assay. Submitter did not handle the vial.
- Assay date
- 25 May 2026
- Submitted to the index
- 02 Jun 2026
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 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 KP-2511-W4792 n=5
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042967 | KP-2511-W4792 | Janoshik | 2026-Q2 | 99.49 | 4.14 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-042968 | KP-2511-W4792 | Janoshik | 2026-Q2 | 98.87 | 4.32 | 91.5 | Buyer-sourced | 2 | FAIL |
| AX-2026-042969 | KP-2511-W4792 | Janoshik | 2026-Q2 | 99.33 | 3.94 | — | Buyer-sourced | 2 | FAIL |
| AX-2026-042971 | KP-2511-W4792 | Janoshik | 2026-Q2 | 99.45 | 4.19 | 107.1 | Supplier-supplied | 2 | FAIL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042753 | GGPeps | GGPE-2512-M9695 | Medutest | 2026-Q2 | 99.21 | 4.61 | 93.5 | Supplier-supplied | 2 | FAIL |
| AX-2026-042969 | KP | KP-2511-W4792 | Janoshik | 2026-Q2 | 99.33 | 3.94 | — | Buyer-sourced | 2 | FAIL |
| AX-2026-042967 | KP | KP-2511-W4792 | Janoshik | 2026-Q2 | 99.49 | 4.14 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-042754 | GGPeps | GGPE-2512-M9695 | PeptideMeter | 2026-Q2 | 99.20 | 4.90 | 96.8 | Supplier-supplied | 2 | FAIL |
| AX-2026-042971 | KP | KP-2511-W4792 | Janoshik | 2026-Q2 | 99.45 | 4.19 | 107.1 | Supplier-supplied | 2 | FAIL |
| AX-2026-042968 | KP | KP-2511-W4792 | Janoshik | 2026-Q2 | 98.87 | 4.32 | 91.5 | Buyer-sourced | 2 | FAIL |
| AX-2026-042012 | TFC | TFC-2508-L6321 | Janoshik | 2026-Q1 | 99.93 | 5.84 | 95.7 | Supplier-supplied | 0 | FAIL |
| AX-2026-042013 | TFC | TFC-2508-L6321 | PeptideMeter | 2026-Q1 | 99.90 | 5.78 | 90.3 | Supplier-supplied | 0 | FAIL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043029 | Retatrutide | KP-2607-H5219 | Medutest | 2026-Q3 | 95.45 | 5.71 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-043030 | Retatrutide | KP-2607-H5219 | Kestrel | 2026-Q3 | 95.97 | 6.95 | 97.1 | Supplier-supplied | 2 | FAIL |
| AX-2026-043106 | Tirzepatide | KP-2608-D5921 | PeptideMeter | 2026-Q3 | 98.90 | 5.45 | 105.4 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043108 | Tirzepatide | KP-2608-D5921 | Janoshik | 2026-Q3 | 99.70 | 5.45 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043039 | Retatrutide | KP-2607-H5219 | Janoshik | 2026-Q3 | 96.14 | 5.62 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-043100 | Tirzepatide | KP-2608-D5921 | VendorInvestigate | 2026-Q3 | 98.27 | 5.31 | 94.4 | Buyer-sourced | 2 | MARGINAL |
| AX-2026-043090 | Ipamorelin | KP-2606-D5887 | Janoshik | 2026-Q3 | 98.18 | 3.07 | 101.2 | Laboratory-retained | 1 | FAIL |
| AX-2026-043028 | Retatrutide | KP-2607-H5219 | Janoshik | 2026-Q3 | 96.52 | 6.09 | — | Supplier-supplied | 2 | MARGINAL |