AX-2025-020504
CJC-1295 with DAC · 10 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2506-L6194
- Report ID
- AX-2025-020504
- Compound
- CJC-1295 with DAC
- Compound class
- Growth-hormone axis peptides
- Supplier
- KP — Zhuhai Kerui Biotechnology Co., Ltd.
- Batch / lot
- KP-2506-L6194
- Declared label claim
- 10mg
- Laboratory
- Nordanalyt Laboratories
- Assay date
- 25 Sep 2025
- Submitted
- 06 Oct 2025
- Quarter
- 2025-Q3
- Submitter
- k.fontaine
- 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, 35 min gradient, 214 nm | 99.52 | % area | ≥ 97.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.48 | % area | ≤ 2.5 | PASS |
| Largest single impurity | RP-HPLC — maleimide dimer | 0.27 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 3644.9748 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 3644.9770 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +0.6 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 91.35 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 90.91 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 9.80 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 8.909 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 89.1 | % | 90.0 – 110.0 | FAIL |
| Water content | Karl Fischer, coulometric, duplicate | 4.93 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 3.48 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.24 | % | — | 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 | Off-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 | 5.33 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 35 min gradient | 16.60 | min | 16.86 ± 0.35 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.86 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 63,165 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs deamidated (+1 Da) | 1.12 | — | 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 | CJC-1295 with DAC — main peak | 16.60 | 4,836,981 | 99.52 | — |
| 2 | maleimide dimer | 19.42 | 13,123 | 0.27 | +3644.975 |
| 3 | mod-GRF (1-29) (−279 Da) | 14.55 | 6,804 | 0.14 | -279.235 |
| 4 | deamidated (+1 Da) | 16.30 | 1,944 | 0.04 | +0.984 |
| 5 | hydrolysed maleimide (+18 Da) | 15.88 | 1,458 | 0.03 | +18.011 |
| 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 3644.9748 Da, computed from C165H269N47O46. 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 (%) |
|---|---|---|---|---|
| 5+ | 730.0022 | 730.0027 | 0.0005 | 9.2 |
| 4+ | 912.2510 | 912.2515 | 0.0005 | 57.6 |
| 3+ | 1215.9989 | 1215.9996 | 0.0007 | 100.0 |
| 2+ | 1823.4947 | 1823.4958 | 0.0011 | 57.0 |
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 | 4.93 |
| Counter-ion (acetate) | ion chromatography | 3.48 |
| Residual solvent + inorganic residue | estimated | 0.24 |
| Total peptide content | by difference | 91.35 |
| 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 | 99.52 | divergence +0.17 pp vs batch median |
| Total impurities (% area) | 0.10 | 0.48 | |
| Largest single impurity (% area) | 0.06 | 0.27 | |
| Water (%) | 4.4 | 4.93 | |
| Counter-ion (%) | not stated | 3.48 | |
| Peptide content (%w/w) | 90.8 | 91.35 | |
| Endotoxin (EU/mg) | 0.83 | 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 (2–8 °C, 2 d) → laboratory (courier, ambient, 4 d) → assay.
- Assay date
- 25 Sep 2025
- Submitted to the index
- 06 Oct 2025
- Laboratory
- Nordanalyt Laboratories, Uppsala, Sweden
- Method basis
- 35 min gradient · high-resolution MS
- Verification status
- VERIFIED
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 KP-2506-L6194 n=2
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-020503 | KP-2506-L6194 | Medutest | 2025-Q3 | 99.93 | 4.79 | — | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041681 | TFS | TFS-{CAT}-9675 | PeptideMeter | 2026-Q3 | 98.82 | 3.67 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041867 | SinoPep | SNP-2607-C3886 | Janoshik | 2026-Q3 | 99.24 | 5.12 | — | Laboratory-retained | 1 | FAIL |
| AX-2026-041682 | TFS | TFS-{CAT}-9675 | Nordanalyt | 2026-Q3 | 98.94 | 3.24 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041683 | TFS | TFS-{CAT}-9675 | Medutest | 2026-Q3 | 98.68 | 3.46 | 97.0 | Buyer-sourced | 0 | PASS |
| AX-2026-043471 | BCH | BCH-2607-H5235 | Janoshik | 2026-Q3 | 97.46 | 5.48 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-043477 | BCH | BCH-2607-H5235 | VendorInvestigate | 2026-Q3 | 97.62 | 5.32 | 99.6 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043470 | BCH | BCH-2607-H5235 | Janoshik | 2026-Q3 | 97.76 | 6.11 | 99.3 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043478 | BCH | BCH-2607-H5235 | PeptideMeter | 2026-Q3 | 97.63 | 5.42 | 90.1 | Buyer-sourced | 1 | MARGINAL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043095 | Retatrutide | KP-2607-H5774 | Janoshik | 2026-Q3 | 95.81 | 5.48 | 105.2 | Buyer-sourced | 0 | FAIL |
| AX-2026-043094 | Retatrutide | KP-2607-H5774 | PeptideMeter | 2026-Q3 | 96.32 | 6.40 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043096 | Retatrutide | KP-2607-H5774 | VendorInvestigate | 2026-Q3 | 96.48 | 6.05 | 104.9 | Buyer-sourced | 0 | FAIL |
| AX-2026-043090 | Retatrutide | KP-2607-H5774 | Janoshik | 2026-Q3 | 96.46 | 5.81 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043091 | Retatrutide | KP-2607-H5774 | Janoshik | 2026-Q3 | 96.13 | 5.94 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043077 | TB-500 | KP-2605-C5214 | Janoshik | 2026-Q2 | 99.61 | 5.64 | 90.2 | Buyer-sourced | 0 | PASS |
| AX-2026-043093 | Retatrutide | KP-2607-H5774 | Janoshik | 2026-Q3 | 96.54 | 5.54 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043092 | Retatrutide | KP-2607-H5774 | Medutest | 2026-Q3 | 96.64 | 6.12 | — | Buyer-sourced | 1 | FAIL |