AX-2025-019967
Ipamorelin · 10 mg declared · Hubei Jianxiang Bioscience Co., Ltd. · lot HJ-2511-D7081
- Report ID
- AX-2025-019967
- Compound
- Ipamorelin
- Compound class
- Growth-hormone axis peptides
- Supplier
- HJ — Hubei Jianxiang Bioscience Co., Ltd.
- Batch / lot
- HJ-2511-D7081
- Declared label claim
- 10mg
- Laboratory
- PeptideMeter
- Assay date
- 09 Oct 2025
- Submitted
- 23 Oct 2025
- Quarter
- 2025-Q4
- Submitter
- a.hovland
- Sample provenance
- Laboratory-retained
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, 28 min gradient, 214 nm | 99.40 | % area | ≥ 99.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.60 | % area | ≤ 1.0 | PASS |
| Largest single impurity | RP-HPLC — oxidised Trp (+16 Da) | 0.43 | % 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 | 90.21 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 89.67 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 9.97 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 8.940 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 89.4 | % | 90.0 – 110.0 | FAIL |
| Water content | Karl Fischer, coulometric, duplicate | 3.55 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.76 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.48 | % | — | 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 cake, partial shrinkage from vial wall | — | white to off-white intact cake | FAIL |
| Reconstitution clarity | reconstituted per submitter procedure | Clear after 90 s gentle swirling, no particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 5.23 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 7.77 | min | 7.73 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.11 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 41,107 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Trp]-epimer | 0.71 | — | 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 | 7.77 | 4,831,148 | 99.40 | — |
| 2 | oxidised Trp (+16 Da) | 7.45 | 20,899 | 0.43 | +15.995 |
| 3 | des-Lys (−128 Da) | 7.56 | 4,860 | 0.10 | -128.095 |
| 4 | C-terminal free acid (+1 Da) | 7.94 | 1,944 | 0.04 | +0.984 |
| 5 | [D-Trp]-epimer | 7.66 | 972 | 0.02 | 0.000 |
| 6 | Aib-deletion sequence (−85 Da) | 7.51 | 486 | 0.01 | -85.053 |
| 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 | 3.55 |
| Counter-ion (acetate) | ion chromatography | 5.76 |
| Residual solvent + inorganic residue | estimated | 0.48 |
| Total peptide content | by difference | 90.21 |
| 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) | 99.43 | 99.40 | divergence +0.41 pp vs batch median |
| Total impurities (% area) | not stated | 0.60 | |
| Largest single impurity (% area) | not stated | 0.43 | |
| Water (%) | 2.3 | 3.55 | |
| Counter-ion (%) | 4.4 | 5.76 | |
| Peptide content (%w/w) | 92.7 | 90.21 | |
| Endotoxin (EU/mg) | 0.93 | 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
- Laboratory-retained
- Evidentiary weight
- Provenance documented, selection uncontrolled.
- Chain of custody
- Laboratory retained sample (−20 °C, 34 d since original receipt) → re-assay.
- Assay date
- 09 Oct 2025
- Submitted to the index
- 23 Oct 2025
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
Annotations 3
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.
Related records
Same batch — lot HJ-2511-D7081 n=6
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-019966 | HJ-2511-D7081 | Nordanalyt | 2025-Q4 | 99.01 | 4.08 | 90.0 | Buyer-sourced | 0 | PASS |
| AX-2025-019968 | HJ-2511-D7081 | Medutest | 2025-Q4 | 99.38 | 3.93 | 92.5 | Buyer-sourced | 1 | FAIL |
| AX-2026-042608 | HJ-2511-D7081 | Kestrel | 2025-Q4 | 98.92 | 3.12 | 90.4 | Buyer-sourced | 0 | FAIL |
| AX-2025-019969 | HJ-2511-D7081 | PeptideMeter | 2025-Q4 | 98.57 | 3.98 | — | Buyer-sourced | 0 | FAIL |
| AX-2025-019970 | HJ-2511-D7081 | Janoshik | 2025-Q4 | 99.02 | 3.77 | 97.6 | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041377 | QYB | QYB-2605-H3558 | Nordanalyt | 2026-Q3 | 99.93 | 4.35 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041913 | SinoPep | SNP-2606-L4478 | PeptideMeter | 2026-Q3 | 98.88 | 5.28 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-041914 | SinoPep | SNP-2606-L4478 | Janoshik | 2026-Q3 | 99.14 | 5.49 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041909 | SinoPep | SNP-2606-L4478 | PeptideMeter | 2026-Q3 | 99.00 | 5.48 | 89.5 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041895 | SinoPep | SNP-2602-B3833 | Janoshik | 2026-Q3 | 99.93 | 4.72 | 105.9 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041898 | SinoPep | SNP-2602-B3833 | Nordanalyt | 2026-Q3 | 99.93 | 4.54 | 96.0 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041899 | SinoPep | SNP-2602-B3833 | PeptideMeter | 2026-Q3 | 99.93 | 4.96 | 90.1 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041891 | SinoPep | SNP-2602-B3833 | Janoshik | 2026-Q3 | 99.93 | 5.11 | — | Buyer-sourced | 1 | MARGINAL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042595 | Semaglutide | HJ-2608-C7002 | Janoshik | 2026-Q3 | 99.50 | 3.55 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042598 | Semaglutide | HJ-2608-C7002 | Janoshik | 2026-Q3 | 99.59 | 3.84 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042605 | Semaglutide | HJ-2608-C7002 | Janoshik | 2026-Q3 | 99.03 | 3.37 | 107.3 | Buyer-sourced | 0 | PASS |
| AX-2026-042602 | Semaglutide | HJ-2608-C7002 | Nordanalyt | 2026-Q3 | 99.21 | 3.50 | 92.0 | Buyer-sourced | 0 | PASS |
| AX-2026-042603 | Semaglutide | HJ-2608-C7002 | Janoshik | 2026-Q3 | 99.16 | 3.42 | 105.9 | Buyer-sourced | 0 | PASS |
| AX-2026-042528 | GHRP-6 | HJ-2603-R5329 | VendorInvestigate | 2026-Q3 | 98.69 | 1.87 | 95.8 | Buyer-sourced | 0 | FAIL |
| AX-2026-042526 | GHRP-6 | HJ-2603-R5329 | Medutest | 2026-Q3 | 99.37 | 3.06 | — | Laboratory-retained | 0 | PASS |
| AX-2026-042527 | GHRP-6 | HJ-2603-R5329 | VendorInvestigate | 2026-Q3 | 99.21 | 2.77 | 93.2 | Buyer-sourced | 0 | PASS |