AX-2024-004914
GHRP-6 · 2 mg declared · Shanghai ERP Biotechnology Co., Ltd. · lot ERP-2408-R7195
- Report ID
- AX-2024-004914
- Compound
- GHRP-6
- Compound class
- Growth-hormone axis peptides
- Supplier
- ERP — Shanghai ERP Biotechnology Co., Ltd.
- Batch / lot
- ERP-2408-R7195
- Declared label claim
- 2mg
- Laboratory
- Janoshik Analytical
- Assay date
- 06 Sep 2024
- Submitted
- 17 Sep 2024
- Quarter
- 2024-Q3
- Submitter
- Contributor #P-1187
- 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, 30 min gradient, 214 nm | 98.96 | % area | ≥ 99.0 | FAIL |
| Total impurities | RP-HPLC, sum of reported peaks | 1.04 | % area | ≤ 1.0 | FAIL |
| Largest single impurity | RP-HPLC — bis-oxidised Trp (+32 Da) | 0.69 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 872.4446 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 872.4495 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +5.6 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 87.46 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 86.55 | %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 | 1.809 | mg | 2 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 90.5 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.53 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 7.04 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.97 | % | — | 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, colourless, no visible particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 5.59 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 8.37 | min | 8.44 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.94 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 79,092 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Trp]-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-6 — main peak | 8.37 | 4,809,763 | 98.96 | — |
| 2 | bis-oxidised Trp (+32 Da) | 7.79 | 33,536 | 0.69 | +31.990 |
| 3 | oxidised Trp (+16 Da) | 8.03 | 7,776 | 0.16 | +15.995 |
| 4 | [D-Trp]-epimer | 8.25 | 5,832 | 0.12 | 0.000 |
| 5 | des-Lys (−128 Da) | 8.15 | 3,402 | 0.07 | -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 872.4446 Da, computed from C46H56N12O6. 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+ | 437.2296 | 437.2320 | 0.0024 | 55.8 |
| 1+ | 873.4519 | 873.4568 | 0.0049 | 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 | 4.53 |
| Counter-ion (acetate) | ion chromatography | 7.04 |
| Residual solvent + inorganic residue | estimated | 0.97 |
| Total peptide content | by difference | 87.46 |
| 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) | 99.33 | 98.96 | divergence +0.36 pp vs batch median |
| Total impurities (% area) | 0.67 | 1.04 | |
| Largest single impurity (% area) | not stated | 0.69 | |
| Water (%) | not stated | 4.53 | |
| Counter-ion (%) | not stated | 7.04 | |
| Peptide content (%w/w) | 91.7 | 87.46 | |
| Endotoxin (EU/mg) | 0.42 | 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, 8 d since original receipt) → re-assay.
- Assay date
- 06 Sep 2024
- Submitted to the index
- 17 Sep 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 ERP-2408-R7195 n=3
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-004913 | ERP-2408-R7195 | Janoshik | 2024-Q3 | 99.59 | 4.61 | 92.3 | Supplier-supplied | 2 | MARGINAL |
| AX-2024-004915 | ERP-2408-R7195 | PeptideMeter | 2024-Q3 | 98.97 | 4.87 | 99.6 | Supplier-supplied | 2 | FAIL |
Cross-sections
- All GHRP-6 records n=169
- All ERP records n=247
- All Janoshik records n=3159
- All 2024-Q3 records n=522
- GHRP-6 by supplier
- GHRP-6 impurity profile
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042290 | HJ | HJ-2603-R2258 | Janoshik | 2026-Q3 | 99.71 | 3.05 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042287 | HJ | HJ-2603-R2258 | VendorInvestigate | 2026-Q3 | 98.79 | 2.43 | 90.9 | Buyer-sourced | 2 | FAIL |
| AX-2026-042288 | HJ | HJ-2603-R2258 | Kestrel | 2026-Q3 | 99.93 | 2.82 | 92.8 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042289 | HJ | HJ-2603-R2258 | Janoshik | 2026-Q3 | 99.53 | 2.67 | 104.7 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-042291 | HJ | HJ-2603-R2258 | Janoshik | 2026-Q3 | 99.60 | 2.94 | 101.3 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043560 | BCH | BCH-2603-Y7018 | Janoshik | 2026-Q2 | 99.25 | 5.25 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043564 | BCH | BCH-2603-Y7018 | Medutest | 2026-Q2 | 98.44 | 4.83 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-043562 | BCH | BCH-2603-Y7018 | PeptideMeter | 2026-Q2 | 98.57 | 4.52 | 97.9 | Supplier-supplied | 1 | FAIL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042574 | TB-500 | ERP-2605-S8022 | VendorInvestigate | 2026-Q3 | 99.54 | 2.91 | 96.4 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042535 | Tesamorelin | ERP-2604-W7280 | Janoshik | 2026-Q3 | 99.19 | 3.89 | 92.7 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042577 | TB-500 | ERP-2605-S8022 | Janoshik | 2026-Q3 | 99.51 | 3.45 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042542 | Tesamorelin | ERP-2604-W7280 | Janoshik | 2026-Q3 | 98.54 | 4.58 | 103.1 | Supplier-supplied | 2 | FAIL |
| AX-2026-042547 | Survodutide | ERP-2605-E7682 | PeptideMeter | 2026-Q3 | 98.25 | 5.44 | 93.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042540 | Tesamorelin | ERP-2604-W7280 | Kestrel | 2026-Q3 | 99.72 | 3.47 | 103.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042575 | TB-500 | ERP-2605-S8022 | Janoshik | 2026-Q3 | 99.93 | 3.36 | 95.5 | Supplier-supplied | 0 | PASS |
| AX-2026-042539 | Tesamorelin | ERP-2604-W7280 | Janoshik | 2026-Q3 | 98.77 | 4.30 | 89.9 | Buyer-sourced | 2 | MARGINAL |