AX-2026-041307
Ipamorelin · 5 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2604-E3153
- Report ID
- AX-2026-041307
- Compound
- Ipamorelin
- Compound class
- Growth-hormone axis peptides
- Supplier
- WWB — Wuhan Wansheng Biotechnology Co., Ltd.
- Batch / lot
- WWB-2604-E3153
- Declared label claim
- 5mg
- Laboratory
- Medutest
- Assay date
- 15 May 2026
- Submitted
- 08 Jun 2026
- Quarter
- 2026-Q2
- Submitter
- f.vermeulen
- 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, 25 min gradient, 214 nm | 99.72 | % area | ≥ 99.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.28 | % area | ≤ 1.0 | PASS |
| Largest single impurity | RP-HPLC — des-Lys (−128 Da) | 0.10 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 711.3856 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, unit resolution (single quadrupole) | 711.3860 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +0.5 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 87.96 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 87.71 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 5.53 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 4.850 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 97.0 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.93 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.10 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 1.01 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.67 | 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 | 4.91 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 6.97 | min | 6.98 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.00 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 87,859 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Trp]-epimer | 1.04 | — | 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 | Ipamorelin — main peak | 6.97 | 4,846,701 | 99.72 | — |
| 2 | des-Lys (−128 Da) | 6.79 | 4,860 | 0.10 | -128.095 |
| 3 | oxidised Trp (+16 Da) | 6.69 | 4,860 | 0.10 | +15.995 |
| 4 | Aib-deletion sequence (−85 Da) | 6.74 | 1,944 | 0.04 | -85.053 |
| 5 | [D-Trp]-epimer | 6.87 | 1,944 | 0.04 | 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.
Mass spectrum and identity
Theoretical monoisotopic mass 711.3856 Da, computed from C38H49N9O5. 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+ | 356.7001 | 356.7003 | 0.0002 | 55.5 |
| 1+ | 712.3929 | 712.3933 | 0.0004 | 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 | 5.93 |
| Counter-ion (acetate) | ion chromatography | 5.10 |
| Residual solvent + inorganic residue | estimated | 1.01 |
| Total peptide content | by difference | 87.96 |
| 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) | 99.90 | 99.72 | divergence -0.03 pp vs batch median |
| Total impurities (% area) | not stated | 0.28 | |
| Largest single impurity (% area) | not stated | 0.10 | |
| Water (%) | 5.0 | 5.93 | |
| Counter-ion (%) | 7.9 | 5.10 | |
| Peptide content (%w/w) | 86.5 | 87.96 | |
| Endotoxin (EU/mg) | 0.40 | 0.67 | |
| 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, 2 d) → assay. Submitter did not handle the vial.
- Assay date
- 15 May 2026
- Submitted to the index
- 08 Jun 2026
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 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 WWB-2604-E3153 n=10
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041303 | WWB-2604-E3153 | Janoshik | 2026-Q2 | 99.93 | 5.92 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041304 | WWB-2604-E3153 | Medutest | 2026-Q2 | 99.93 | 6.34 | 100.6 | Supplier-supplied | 1 | FAIL |
| AX-2026-041305 | WWB-2604-E3153 | VendorInvestigate | 2026-Q2 | 99.93 | 5.90 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041306 | WWB-2604-E3153 | Janoshik | 2026-Q2 | 99.93 | 5.18 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041308 | WWB-2604-E3153 | VendorInvestigate | 2026-Q2 | 99.93 | 6.24 | 103.9 | Buyer-sourced | 0 | PASS |
| AX-2026-041309 | WWB-2604-E3153 | Janoshik | 2026-Q2 | 99.93 | 6.14 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041310 | WWB-2604-E3153 | Janoshik | 2026-Q2 | 99.93 | 5.33 | 100.5 | Supplier-supplied | 0 | PASS |
| AX-2026-041311 | WWB-2604-E3153 | Janoshik | 2026-Q2 | 99.93 | 5.52 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041312 | WWB-2604-E3153 | Medutest | 2026-Q2 | 99.89 | 6.39 | 104.4 | Laboratory-retained | 1 | MARGINAL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042181 | Homopeptide | HOMO-2608-A9045 | Janoshik | 2026-Q3 | 99.78 | 4.79 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042180 | Homopeptide | HOMO-2608-A9045 | Janoshik | 2026-Q3 | 99.39 | 4.74 | 105.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042184 | Homopeptide | HOMO-2608-A9045 | Kestrel | 2026-Q3 | 99.27 | 4.79 | 103.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041427 | QYB | QYB-2605-H4298 | Janoshik | 2026-Q3 | 99.93 | 4.12 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042183 | Homopeptide | HOMO-2608-A9045 | VendorInvestigate | 2026-Q3 | 99.38 | 4.97 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043090 | KP | KP-2606-D5887 | Janoshik | 2026-Q3 | 98.18 | 3.07 | 101.2 | Laboratory-retained | 1 | FAIL |
| AX-2026-042191 | Homopeptide | HOMO-2608-A9045 | Medutest | 2026-Q3 | 99.67 | 5.00 | 104.6 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041425 | QYB | QYB-2605-H4298 | Janoshik | 2026-Q3 | 99.93 | 3.65 | 93.4 | Supplier-supplied | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041275 | Liraglutide | WWB-2607-X2189 | Nordanalyt | 2026-Q3 | 99.61 | 5.03 | 97.3 | Supplier-supplied | 0 | PASS |
| AX-2026-041387 | BPC-157 | WWB-2606-H3906 | Janoshik | 2026-Q3 | 98.95 | 4.64 | — | Laboratory-retained | 1 | MARGINAL |
| AX-2026-041334 | Semaglutide | WWB-2606-N3192 | Janoshik | 2026-Q3 | 98.83 | 5.04 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041337 | Semaglutide | WWB-2606-N3192 | Nordanalyt | 2026-Q3 | 98.96 | 4.81 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041385 | BPC-157 | WWB-2606-H3906 | Medutest | 2026-Q3 | 99.31 | 4.31 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041390 | BPC-157 | WWB-2606-H3906 | Medutest | 2026-Q3 | 99.47 | 4.84 | 99.3 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041386 | BPC-157 | WWB-2606-H3906 | VendorInvestigate | 2026-Q3 | 99.32 | 4.88 | 99.2 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041335 | Semaglutide | WWB-2606-N3192 | Janoshik | 2026-Q3 | 99.55 | 4.55 | 100.5 | Supplier-supplied | 1 | MARGINAL |