AX-2026-042909
5-Amino-1MQ · 100 mg declared · Xi'an Mokemei Biotechnology Co., Ltd. · lot MKM-2506-T2989
- Report ID
- AX-2026-042909
- Compound
- 5-Amino-1MQ
- Compound class
- Non-peptide adjuncts
- Supplier
- MKM — Xi'an Mokemei Biotechnology Co., Ltd.
- Batch / lot
- MKM-2506-T2989
- Declared label claim
- 100mg
- Laboratory
- Kestrel Bioanalytical
- Assay date
- 26 Dec 2025
- Submitted
- 21 Jan 2026
- Quarter
- 2025-Q4
- Submitter
- ph_recon
- 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, 15 min gradient, 214 nm | 99.10 | % area | ≥ 98.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.90 | % area | ≤ 2.0 | PASS |
| Largest single impurity | RP-HPLC — free iodide (counter-ion, by IC) | 0.38 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 285.9967 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, unit resolution (single quadrupole) | 285.9958 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -3.2 | ppm | ± 10 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 50.52 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 50.07 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 199.47 | mg | 100 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 99.875 | mg | 100 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 99.9 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.46 | % | ≤ 10.0 | PASS |
| Counter-ion (iodide) | anion-exchange ion chromatography | 42.14 | % | ≤ 12.0 | FAIL |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.88 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 1.68 | 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 | 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 | 4.82 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 15 min gradient | 2.74 | min | 2.93 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.95 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 76,018 | — | ≥ 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 | 2.74 | 4,816,567 | 99.10 | — |
| 2 | free iodide (counter-ion, by IC) | 2.74 | 18,469 | 0.38 | 0.000 |
| 3 | 8-amino regioisomer | 2.85 | 14,095 | 0.29 | 0.000 |
| 4 | 5-nitro-1MQ (unreduced precursor, +30 Da) | 3.08 | 7,776 | 0.16 | +29.974 |
| 5 | 1-methylquinolinium (des-amino, −15 Da) | 2.58 | 3,402 | 0.07 | -15.011 |
| 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.
Mass spectrum and identity
Theoretical monoisotopic mass 285.9967 Da, computed from C10H11N2+ · I−. 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 (%) |
|---|---|---|---|---|
| 1+ | 287.0040 | 287.0031 | -0.0009 | 100.0 |
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 | 6.46 |
| Counter-ion (iodide) | ion chromatography | 42.14 |
| Residual solvent + inorganic residue | estimated | 0.88 |
| Total peptide content | by difference | 50.52 |
| 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) | 99.59 | 99.10 | divergence +0.50 pp vs batch median |
| Total impurities (% area) | not stated | 0.90 | |
| Largest single impurity (% area) | not stated | 0.38 | |
| Water (%) | 5.4 | 6.46 | |
| Counter-ion (%) | not stated | 42.14 | |
| Peptide content (%w/w) | 89.8 | 50.52 | |
| Endotoxin (EU/mg) | not stated | 1.68 | |
| 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, 5 d) → assay. Submitter did not handle the vial.
- Assay date
- 26 Dec 2025
- Submitted to the index
- 21 Jan 2026
- Laboratory
- Kestrel Bioanalytical, Melbourne, Australia
- Method basis
- 15 min gradient · unit-resolution MS
- Verification status
- IDENTITY CONSISTENT
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot MKM-2506-T2989 n=7
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-020271 | MKM-2506-T2989 | Janoshik | 2025-Q4 | 98.77 | 6.45 | — | Supplier-supplied | 1 | FAIL |
| AX-2026-042910 | MKM-2506-T2989 | Medutest | 2025-Q4 | 98.99 | 6.67 | 103.1 | Supplier-supplied | 1 | FAIL |
| AX-2025-020272 | MKM-2506-T2989 | Janoshik | 2025-Q4 | 99.09 | 6.23 | — | Supplier-supplied | 2 | FAIL |
| AX-2025-020273 | MKM-2506-T2989 | Janoshik | 2025-Q4 | 99.12 | 6.15 | — | Supplier-supplied | 1 | FAIL |
| AX-2025-020274 | MKM-2506-T2989 | Kestrel | 2025-Q4 | 99.58 | 6.05 | 98.7 | Supplier-supplied | 2 | FAIL |
| AX-2025-020275 | MKM-2506-T2989 | Nordanalyt | 2025-Q4 | 98.68 | 6.58 | 93.5 | Supplier-supplied | 1 | 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-2026-042970 | KP | KP-2511-W4792 | Janoshik | 2026-Q2 | 98.89 | 4.03 | 91.0 | 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 |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042943 | Adipotide | MKM-2606-K4013 | Janoshik | 2026-Q3 | 97.92 | 6.31 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042891 | CJC-1295 (no DAC) | MKM-2603-V2347 | Janoshik | 2026-Q3 | 99.28 | 3.63 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042942 | Adipotide | MKM-2606-K4013 | VendorInvestigate | 2026-Q3 | 97.04 | 5.56 | 94.6 | Buyer-sourced | 1 | FAIL |
| AX-2026-042914 | Gonadorelin | MKM-2604-A2596 | Janoshik | 2026-Q2 | 99.93 | 5.19 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042884 | BPC-157 | MKM-2605-X2575 | Nordanalyt | 2026-Q2 | 98.12 | 2.89 | — | Laboratory-retained | 1 | MARGINAL |
| AX-2026-042946 | Tirzepatide | MKM-2601-L3752 | Medutest | 2026-Q2 | 97.71 | 8.10 | — | Supplier-supplied | 1 | FAIL |
| AX-2026-042911 | Gonadorelin | MKM-2604-A2596 | Medutest | 2026-Q2 | 99.08 | 5.55 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042932 | L-Glutathione (reduced) | MKM-2511-F2902 | Janoshik | 2026-Q2 | 98.57 | 8.41 | 92.9 | Supplier-supplied | 1 | MARGINAL |