AX-2025-020267
CJC-1295 (no DAC) · 10 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2507-D1397
- Report ID
- AX-2025-020267
- Compound
- CJC-1295 (no DAC)
- Compound class
- Growth-hormone axis peptides
- Supplier
- GGPeps — Nantong Guangyuan Chemical Co., Ltd.
- Batch / lot
- GGPE-2507-D1397
- Declared label claim
- 10mg
- Laboratory
- Janoshik Analytical
- Assay date
- 25 Nov 2025
- Submitted
- 17 Dec 2025
- Quarter
- 2025-Q4
- Submitter
- as.vestergaard
- 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 | 98.42 | % area | ≥ 98.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.58 | % area | ≤ 2.0 | PASS |
| Largest single impurity | RP-HPLC — deamidated (+1 Da) | 0.66 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 3365.7402 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 3365.7399 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -0.1 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 90.91 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 89.47 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.20 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 10.021 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 100.2 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.52 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 4.27 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.30 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.33 | 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 | 5.19 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 12.04 | min | 12.86 ± 0.30 (normalised) | FAIL |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.13 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 64,088 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs deamidated (+1 Da) | 1.23 | — | 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 (no DAC) — main peak | 12.04 | 4,783,517 | 98.42 | — |
| 2 | deamidated (+1 Da) | 11.80 | 32,078 | 0.66 | +0.984 |
| 3 | native GRF (1-29) (−59 Da) | 11.70 | 24,302 | 0.50 | -58.995 |
| 4 | des-Tyr1 (−163 Da) | 11.50 | 9,721 | 0.20 | -163.063 |
| 5 | truncated (1-24) | 10.88 | 7,290 | 0.15 | -570.291 |
| 6 | acetyl adduct (+42 Da) | 12.48 | 3,402 | 0.07 | +42.011 |
| 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 3365.7402 Da, computed from C152H252N44O42. 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+ | 674.1553 | 674.1553 | -0.0000 | 8.0 |
| 4+ | 842.4423 | 842.4423 | -0.0000 | 57.7 |
| 3+ | 1122.9207 | 1122.9206 | -0.0001 | 100.0 |
| 2+ | 1683.8774 | 1683.8772 | -0.0002 | 57.2 |
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 | 4.52 |
| Counter-ion (acetate) | ion chromatography | 4.27 |
| Residual solvent + inorganic residue | estimated | 0.30 |
| Total peptide content | by difference | 90.91 |
| 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) | 98.39 | 98.42 | divergence -0.03 pp vs batch median |
| Total impurities (% area) | 1.61 | 1.58 | |
| Largest single impurity (% area) | 0.88 | 0.66 | |
| Water (%) | 2.2 | 4.52 | |
| Counter-ion (%) | not stated | 4.27 | |
| Peptide content (%w/w) | not stated | 90.91 | |
| Endotoxin (EU/mg) | not stated | 0.33 | |
| 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 (ambient, 29 d) → laboratory (hand-carried, 4 d) → assay.
- Assay date
- 25 Nov 2025
- Submitted to the index
- 17 Dec 2025
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- VERIFIED
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 GGPE-2507-D1397 n=3
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-020265 | GGPE-2507-D1397 | Janoshik | 2025-Q4 | 98.78 | 4.05 | — | Buyer-sourced | 0 | PASS |
| AX-2025-020266 | GGPE-2507-D1397 | Medutest | 2025-Q4 | 98.08 | 4.39 | 95.0 | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042942 | MKM | MKM-2603-V3346 | Janoshik | 2026-Q3 | 99.52 | 3.43 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041599 | QSC | QSC-2606-V7416 | VendorInvestigate | 2026-Q3 | 97.96 | 3.52 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-042784 | GGPeps | GGPE-2606-E1234 | Medutest | 2026-Q3 | 98.27 | 4.55 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042939 | MKM | MKM-2603-V3346 | PeptideMeter | 2026-Q3 | 99.44 | 3.39 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041601 | QSC | QSC-2606-V7416 | Kestrel | 2026-Q3 | 98.33 | 4.10 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042945 | MKM | MKM-2603-V3346 | PeptideMeter | 2026-Q3 | 99.39 | 3.54 | — | Laboratory-retained | 0 | PASS |
| AX-2026-042786 | GGPeps | GGPE-2606-E1234 | Janoshik | 2026-Q3 | 98.22 | 3.77 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041602 | QSC | QSC-2606-V7416 | VendorInvestigate | 2026-Q3 | 98.36 | 3.38 | 101.8 | Buyer-sourced | 1 | MARGINAL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042784 | CJC-1295 (no DAC) | GGPE-2606-E1234 | Medutest | 2026-Q3 | 98.27 | 4.55 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042786 | CJC-1295 (no DAC) | GGPE-2606-E1234 | Janoshik | 2026-Q3 | 98.22 | 3.77 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042858 | Selank | GGPE-2603-J2447 | VendorInvestigate | 2026-Q3 | 98.87 | 8.85 | 99.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042783 | CJC-1295 (no DAC) | GGPE-2606-E1234 | Janoshik | 2026-Q3 | 98.22 | 4.45 | 90.6 | Buyer-sourced | 0 | PASS |
| AX-2026-042757 | Melanotan II | GGPE-2603-P1474 | Janoshik | 2026-Q3 | 99.54 | 6.78 | 92.0 | Buyer-sourced | 0 | PASS |
| AX-2026-042785 | CJC-1295 (no DAC) | GGPE-2606-E1234 | PeptideMeter | 2026-Q3 | 97.70 | 4.64 | 91.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042756 | Melanotan II | GGPE-2603-P1474 | Nordanalyt | 2026-Q3 | 99.17 | 7.04 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042755 | Melanotan II | GGPE-2603-P1474 | Nordanalyt | 2026-Q3 | 99.25 | 6.58 | 90.4 | Buyer-sourced | 0 | PASS |