AX-2024-004535
Hexarelin · 2 mg declared · Shenzhen Hybio Pharmaceutical Co., Ltd. · lot HYB-2407-N7367
- Report ID
- AX-2024-004535
- Compound
- Hexarelin
- Compound class
- Growth-hormone axis peptides
- Supplier
- HYB — Shenzhen Hybio Pharmaceutical Co., Ltd.
- Batch / lot
- HYB-2407-N7367
- Declared label claim
- 2mg
- Laboratory
- Janoshik Analytical
- Assay date
- 12 Sep 2024
- Submitted
- 14 Sep 2024
- Quarter
- 2024-Q3
- Submitter
- fa.sjoberg
- Sample provenance
- Buyer-sourced
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 | 99.93 | % area | ≥ 99.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.07 | % area | ≤ 1.0 | PASS |
| Largest single impurity | RP-HPLC — des-Lys (−128 Da) | 0.05 | % 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 | 88.55 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 88.49 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 2.09 | mg | 2 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 1.849 | mg | 2 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 92.5 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.83 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.83 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.79 | % | — | 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 | 5.06 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 8.83 | min | 8.92 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.20 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 74,229 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs des-Lys (−128 Da) | 1.66 | — | 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 | Hexarelin — main peak | 8.83 | 4,856,908 | 99.93 | — |
| 2 | des-Lys (−128 Da) | 8.61 | 2,430 | 0.05 | -128.095 |
| 3 | des-methyl hexarelin (GHRP-6, −14 Da) | 8.35 | 972 | 0.02 | -14.016 |
| 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 | 4.83 |
| Counter-ion (acetate) | ion chromatography | 5.83 |
| Residual solvent + inorganic residue | estimated | 0.79 |
| Total peptide content | by difference | 88.55 |
| 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) | 99.58 | 99.93 | divergence -0.35 pp vs batch median |
| Total impurities (% area) | 0.42 | 0.07 | |
| Largest single impurity (% area) | not stated | 0.05 | |
| Water (%) | not stated | 4.83 | |
| Counter-ion (%) | not stated | 5.83 | |
| Peptide content (%w/w) | not stated | 88.55 | |
| Endotoxin (EU/mg) | 0.26 | not determined | |
| 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
- Buyer-sourced
- Evidentiary weight
- Strongest available evidence in this index.
- Chain of custody
- Retail purchase → submitter (−20 °C, 10 d) → laboratory (courier, dry ice, 9 d) → assay.
- Assay date
- 12 Sep 2024
- Submitted to the index
- 14 Sep 2024
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
Annotations 2
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 HYB-2407-N7367 n=11
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-004534 | HYB-2407-N7367 | Janoshik | 2024-Q3 | 99.93 | 4.71 | 102.5 | Buyer-sourced | 0 | PASS |
| AX-2024-004536 | HYB-2407-N7367 | Janoshik | 2024-Q3 | 99.93 | 5.50 | 105.9 | Buyer-sourced | 0 | PASS |
| AX-2024-004537 | HYB-2407-N7367 | Janoshik | 2024-Q3 | 99.77 | 4.67 | 95.0 | Buyer-sourced | 0 | PASS |
| AX-2024-004538 | HYB-2407-N7367 | Janoshik | 2024-Q3 | 99.93 | 5.12 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2024-004539 | HYB-2407-N7367 | VendorInvestigate | 2024-Q3 | 99.88 | 4.99 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004540 | HYB-2407-N7367 | Kestrel | 2024-Q3 | 99.80 | 5.35 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004541 | HYB-2407-N7367 | Janoshik | 2024-Q3 | 99.93 | 5.44 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004542 | HYB-2407-N7367 | PeptideMeter | 2024-Q3 | 99.35 | 5.55 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004543 | HYB-2407-N7367 | PeptideMeter | 2024-Q3 | 99.93 | 5.19 | 95.3 | Buyer-sourced | 0 | PASS |
| AX-2024-004544 | HYB-2407-N7367 | PeptideMeter | 2024-Q3 | 99.77 | 5.05 | 102.9 | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042177 | JEEP | JEEP-2608-Y9547 | Janoshik | 2026-Q3 | 99.90 | 3.42 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042178 | JEEP | JEEP-2608-Y9547 | VendorInvestigate | 2026-Q3 | 99.68 | 4.03 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043097 | KP | KP-2604-X5990 | Medutest | 2026-Q2 | 99.55 | 2.60 | — | Laboratory-retained | 0 | PASS |
| AX-2026-043253 | CPC | CPC-2511-F9455 | Janoshik | 2026-Q2 | 98.53 | 6.11 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043098 | KP | KP-2604-X5990 | PeptideMeter | 2026-Q2 | 98.66 | 3.14 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-042366 | Homopeptide | HOMO-2602-R3080 | Janoshik | 2026-Q2 | 99.55 | 4.14 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042365 | Homopeptide | HOMO-2602-R3080 | PeptideMeter | 2026-Q2 | 99.66 | 4.44 | 94.8 | Buyer-sourced | 0 | PASS |
| AX-2026-043100 | KP | KP-2604-X5990 | Janoshik | 2026-Q2 | 98.82 | 3.57 | 92.0 | Buyer-sourced | 0 | FAIL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042083 | MOTS-c | HYB-2606-D7858 | Medutest | 2026-Q3 | 99.93 | 2.02 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042090 | MOTS-c | HYB-2606-D7858 | Janoshik | 2026-Q3 | 99.57 | 2.36 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-042084 | MOTS-c | HYB-2606-D7858 | Janoshik | 2026-Q3 | 99.28 | 2.79 | 107.3 | Buyer-sourced | 0 | PASS |
| AX-2026-042087 | MOTS-c | HYB-2606-D7858 | Janoshik | 2026-Q3 | 99.54 | 3.05 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042085 | MOTS-c | HYB-2606-D7858 | Janoshik | 2026-Q3 | 99.51 | 2.31 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042088 | MOTS-c | HYB-2606-D7858 | PeptideMeter | 2026-Q3 | 99.22 | 2.21 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042086 | MOTS-c | HYB-2606-D7858 | Janoshik | 2026-Q3 | 99.93 | 3.02 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042091 | CJC-1295 with DAC | HYB-2608-E7391 | Janoshik | 2026-Q3 | 99.38 | 5.53 | — | Buyer-sourced | 0 | PASS |