AX-2024-005040
GHRP-2 · 2 mg declared · Xi'an Mokemei Biotechnology Co., Ltd. · lot MKM-2405-A2532
- Report ID
- AX-2024-005040
- Compound
- GHRP-2
- Compound class
- Growth-hormone axis peptides
- Supplier
- MKM — Xi'an Mokemei Biotechnology Co., Ltd.
- Batch / lot
- MKM-2405-A2532
- Declared label claim
- 2mg
- Laboratory
- Janoshik Analytical
- Assay date
- 06 Oct 2024
- Submitted
- 20 Oct 2024
- Quarter
- 2024-Q4
- Submitter
- c.danquah
- Sample provenance
- Supplier-supplied
Results
Measured against the index acceptance specification for the growth-hormone axis peptides 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 | 99.57 | % area | ≥ 99.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.43 | % area | ≤ 1.0 | PASS |
| Largest single impurity | RP-HPLC — [D-2-Nal]-epimer | 0.22 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 817.4275 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 817.4327 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +6.4 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 86.84 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 86.47 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 2.42 | mg | 2 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 2.093 | mg | 2 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 104.7 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.82 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 6.48 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.86 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.20 | 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 | 5.84 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 9.12 | min | 9.06 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.10 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 68,848 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-2-Nal]-epimer | 0.98 | — | 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 | GHRP-2 — main peak | 9.12 | 4,839,411 | 99.57 | — |
| 2 | [D-2-Nal]-epimer | 8.98 | 10,693 | 0.22 | 0.000 |
| 3 | oxidised Trp (+16 Da) | 8.76 | 6,318 | 0.13 | +15.995 |
| 4 | C-terminal free acid (+1 Da) | 9.28 | 2,916 | 0.06 | +0.984 |
| 5 | des-Lys (−128 Da) | 8.88 | 972 | 0.02 | -128.095 |
| 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 817.4275 Da, computed from C45H55N9O6. 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 (%) |
|---|---|---|---|---|
| 2+ | 409.7210 | 409.7236 | 0.0026 | 54.2 |
| 1+ | 818.4348 | 818.4400 | 0.0052 | 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 | 5.82 |
| Counter-ion (acetate) | ion chromatography | 6.48 |
| Residual solvent + inorganic residue | estimated | 0.86 |
| Total peptide content | by difference | 86.84 |
| 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) | 99.37 | 99.57 | divergence +0.22 pp vs batch median |
| Total impurities (% area) | 0.63 | 0.43 | |
| Largest single impurity (% area) | 0.46 | 0.22 | |
| Water (%) | 5.4 | 5.82 | |
| Counter-ion (%) | 5.2 | 6.48 | |
| Peptide content (%w/w) | 88.8 | 86.84 | |
| Endotoxin (EU/mg) | not stated | 0.20 | |
| 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, 10 d) → assay. Submitter did not handle the vial.
- Assay date
- 06 Oct 2024
- Submitted to the index
- 20 Oct 2024
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- VERIFIED
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-2405-A2532 n=4
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-005039 | MKM-2405-A2532 | Janoshik | 2024-Q4 | 99.35 | 7.04 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005041 | MKM-2405-A2532 | Nordanalyt | 2024-Q4 | 98.94 | 6.23 | 100.5 | Supplier-supplied | 1 | FAIL |
| AX-2024-005042 | MKM-2405-A2532 | Janoshik | 2024-Q4 | 98.44 | 6.54 | 103.3 | Laboratory-retained | 1 | FAIL |
Cross-sections
- All GHRP-2 records n=97
- All MKM records n=272
- All Janoshik records n=3159
- All 2024-Q4 records n=434
- GHRP-2 by supplier
- GHRP-2 impurity profile
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042161 | Homopeptide | HOMO-2602-E9033 | Medutest | 2026-Q2 | 99.93 | 3.99 | 105.6 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042302 | HJ | HJ-2602-W3148 | PeptideMeter | 2026-Q2 | 99.55 | 1.32 | 104.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042159 | Homopeptide | HOMO-2602-E9033 | Janoshik | 2026-Q2 | 99.39 | 3.77 | — | Laboratory-retained | 1 | MARGINAL |
| AX-2026-042303 | HJ | HJ-2602-W3148 | PeptideMeter | 2026-Q2 | 99.12 | 1.24 | 98.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042160 | Homopeptide | HOMO-2602-E9033 | Medutest | 2026-Q2 | 99.62 | 4.50 | 99.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043489 | WXT | WXT-2605-U5824 | PeptideMeter | 2026-Q2 | 98.83 | 5.76 | 96.6 | Supplier-supplied | 2 | FAIL |
| AX-2026-042157 | Homopeptide | HOMO-2602-E9033 | PeptideMeter | 2026-Q2 | 99.93 | 4.32 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042158 | Homopeptide | HOMO-2602-E9033 | Janoshik | 2026-Q2 | 99.59 | 4.35 | 89.8 | Buyer-sourced | 2 | MARGINAL |
| 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 |