AX-2026-042669
CJC-1295 (no DAC) · 10 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2606-E8495
- Report ID
- AX-2026-042669
- Compound
- CJC-1295 (no DAC)
- Compound class
- Growth-hormone axis peptides
- Supplier
- GGPeps — Nantong Guangyuan Chemical Co., Ltd.
- Batch / lot
- GGPE-2606-E8495
- Declared label claim
- 10mg
- Laboratory
- Medutest
- Assay date
- 06 Sep 2026
- Submitted
- 26 Sep 2026
- Quarter
- 2026-Q3
- Submitter
- l.grimaldi
- Sample provenance
- Supplier-supplied
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, 25 min gradient, 214 nm | 98.61 | % area | ≥ 98.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.39 | % area | ≤ 2.0 | PASS |
| Largest single impurity | RP-HPLC — truncated (1-24) | 0.88 | % 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 | 90.57 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 89.31 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 10.69 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 9.547 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 95.5 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.06 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 4.92 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.45 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.30 | 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 | 4.60 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 10.98 | min | 10.89 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.97 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 80,032 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs deamidated (+1 Da) | 1.26 | — | 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 | 10.98 | 4,792,752 | 98.61 | — |
| 2 | truncated (1-24) | 10.01 | 42,771 | 0.88 | -570.291 |
| 3 | des-Tyr1 (−163 Da) | 10.53 | 14,581 | 0.30 | -163.063 |
| 4 | deamidated (+1 Da) | 10.78 | 7,290 | 0.15 | +0.984 |
| 5 | acetyl adduct (+42 Da) | 11.35 | 1,458 | 0.03 | +42.011 |
| 6 | native GRF (1-29) (−59 Da) | 10.70 | 1,458 | 0.03 | -58.995 |
| 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 | 4.06 |
| Counter-ion (acetate) | ion chromatography | 4.92 |
| Residual solvent + inorganic residue | estimated | 0.45 |
| Total peptide content | by difference | 90.57 |
| 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) | 98.38 | 98.61 | divergence +0.31 pp vs batch median |
| Total impurities (% area) | 1.62 | 1.39 | |
| Largest single impurity (% area) | 0.69 | 0.88 | |
| Water (%) | 2.7 | 4.06 | |
| Counter-ion (%) | 6.2 | 4.92 | |
| Peptide content (%w/w) | 90.5 | 90.57 | |
| Endotoxin (EU/mg) | not stated | 0.30 | |
| 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
- Supplier-supplied
- Evidentiary weight
- Weaker evidence. Read with the caveat below.
- Chain of custody
- Supplier despatch → laboratory direct (courier, cold pack, 8 d) → assay. Submitter did not handle the vial.
- Assay date
- 06 Sep 2026
- Submitted to the index
- 26 Sep 2026
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- PURITY ONLY
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot GGPE-2606-E8495 n=12
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042659 | GGPE-2606-E8495 | Janoshik | 2026-Q3 | 98.56 | 3.74 | 95.8 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042660 | GGPE-2606-E8495 | PeptideMeter | 2026-Q3 | 97.88 | 3.38 | — | Supplier-supplied | 1 | FAIL |
| AX-2026-042661 | GGPE-2606-E8495 | Nordanalyt | 2026-Q3 | 98.24 | 4.09 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042662 | GGPE-2606-E8495 | Janoshik | 2026-Q3 | 97.89 | 4.11 | 95.1 | Supplier-supplied | 0 | FAIL |
| AX-2026-042663 | GGPE-2606-E8495 | Medutest | 2026-Q3 | 97.96 | 4.14 | 90.0 | Laboratory-retained | 2 | FAIL |
| AX-2026-042664 | GGPE-2606-E8495 | Nordanalyt | 2026-Q3 | 97.75 | 3.84 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-042665 | GGPE-2606-E8495 | Janoshik | 2026-Q3 | 98.44 | 4.00 | 93.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042666 | GGPE-2606-E8495 | Janoshik | 2026-Q3 | 97.87 | 3.74 | 94.3 | Buyer-sourced | 2 | FAIL |
| AX-2026-042667 | GGPE-2606-E8495 | Janoshik | 2026-Q3 | 98.13 | 4.22 | 106.1 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042668 | GGPE-2606-E8495 | Nordanalyt | 2026-Q3 | 98.02 | 4.53 | 103.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042670 | GGPE-2606-E8495 | Janoshik | 2026-Q3 | 98.32 | 4.96 | — | Supplier-supplied | 1 | MARGINAL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041683 | QSC | QSC-2606-V8637 | Janoshik | 2026-Q3 | 99.93 | 3.63 | 97.1 | Supplier-supplied | 1 | FAIL |
| AX-2026-042665 | GGPeps | GGPE-2606-E8495 | Janoshik | 2026-Q3 | 98.44 | 4.00 | 93.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042663 | GGPeps | GGPE-2606-E8495 | Medutest | 2026-Q3 | 97.96 | 4.14 | 90.0 | Laboratory-retained | 2 | FAIL |
| AX-2026-042662 | GGPeps | GGPE-2606-E8495 | Janoshik | 2026-Q3 | 97.89 | 4.11 | 95.1 | Supplier-supplied | 0 | FAIL |
| AX-2026-041686 | QSC | QSC-2606-V8637 | Janoshik | 2026-Q3 | 99.93 | 4.04 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042666 | GGPeps | GGPE-2606-E8495 | Janoshik | 2026-Q3 | 97.87 | 3.74 | 94.3 | Buyer-sourced | 2 | FAIL |
| AX-2026-042668 | GGPeps | GGPE-2606-E8495 | Nordanalyt | 2026-Q3 | 98.02 | 4.53 | 103.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041685 | QSC | QSC-2606-V8637 | Medutest | 2026-Q3 | 99.93 | 3.62 | — | Supplier-supplied | 1 | FAIL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042737 | Selank | GGPE-2603-J9708 | Janoshik | 2026-Q3 | 98.40 | 9.14 | 97.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042804 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.50 | 7.97 | — | Supplier-supplied | 0 | FAIL |
| AX-2026-042803 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.48 | 8.01 | — | Laboratory-retained | 1 | FAIL |
| AX-2026-042802 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.74 | 7.09 | 96.0 | Supplier-supplied | 0 | FAIL |
| AX-2026-042796 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.26 | 7.56 | 97.5 | Buyer-sourced | 0 | FAIL |
| AX-2026-042648 | Melanotan II | GGPE-2603-P8735 | Janoshik | 2026-Q3 | 99.10 | 6.97 | — | Supplier-supplied | 4 | MARGINAL |
| AX-2026-042797 | Selank | GGPE-2602-G2056 | Medutest | 2026-Q3 | 98.46 | 7.92 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-042743 | Selank | GGPE-2603-J9708 | Medutest | 2026-Q3 | 99.59 | 9.37 | — | Supplier-supplied | 0 | PASS |