AX-2026-041600
CJC-1295 (no DAC) · 2 mg declared · Qingdao Sigma Chemical Co., Ltd. · lot QSC-2606-V7416
- Report ID
- AX-2026-041600
- Compound
- CJC-1295 (no DAC)
- Compound class
- Growth-hormone axis peptides
- Supplier
- QSC — Qingdao Sigma Chemical Co., Ltd.
- Batch / lot
- QSC-2606-V7416
- Declared label claim
- 2mg
- Laboratory
- Nordanalyt Laboratories
- Assay date
- 26 Aug 2026
- Submitted
- 03 Sep 2026
- Quarter
- 2026-Q3
- Submitter
- esi_tof
- 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 | 97.74 | % area | ≥ 98.0 | FAIL |
| Total impurities | RP-HPLC, sum of reported peaks | 2.26 | % area | ≤ 2.0 | FAIL |
| Largest single impurity | RP-HPLC — des-Tyr1 (−163 Da) | 0.84 | % 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 | 90.90 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 88.85 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 2.27 | mg | 2 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 2.017 | mg | 2 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 100.9 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.91 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 3.46 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.73 | % | — | 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, partially collapsed | — | 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 | 5.92 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 35 min gradient | 14.84 | min | 14.83 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.11 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 51,404 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs deamidated (+1 Da) | 1.04 | — | 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 | 14.84 | 4,750,467 | 97.74 | — |
| 2 | des-Tyr1 (−163 Da) | 14.21 | 40,827 | 0.84 | -163.063 |
| 3 | native GRF (1-29) (−59 Da) | 14.44 | 32,564 | 0.67 | -58.995 |
| 4 | truncated (1-24) | 13.49 | 22,357 | 0.46 | -570.291 |
| 5 | acetyl adduct (+42 Da) | 15.35 | 7,290 | 0.15 | +42.011 |
| 6 | deamidated (+1 Da) | 14.56 | 6,804 | 0.14 | +0.984 |
| 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 | 4.91 |
| Counter-ion (acetate) | ion chromatography | 3.46 |
| Residual solvent + inorganic residue | estimated | 0.73 |
| Total peptide content | by difference | 90.90 |
| 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) | 97.60 | 97.74 | divergence -0.43 pp vs batch median |
| Total impurities (% area) | not stated | 2.26 | |
| Largest single impurity (% area) | not stated | 0.84 | |
| Water (%) | not stated | 4.91 | |
| Counter-ion (%) | not stated | 3.46 | |
| Peptide content (%w/w) | not stated | 90.90 | |
| Endotoxin (EU/mg) | not stated | 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 → third-party forwarder (29 d) → laboratory (courier, cold pack, 3 d) → assay.
- Assay date
- 26 Aug 2026
- Submitted to the index
- 03 Sep 2026
- Laboratory
- Nordanalyt Laboratories, Uppsala, Sweden
- Method basis
- 35 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
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 QSC-2606-V7416 n=9
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041598 | QSC-2606-V7416 | Janoshik | 2026-Q3 | 98.16 | 3.76 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041599 | QSC-2606-V7416 | VendorInvestigate | 2026-Q3 | 97.96 | 3.52 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-041601 | QSC-2606-V7416 | Kestrel | 2026-Q3 | 98.33 | 4.10 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041602 | QSC-2606-V7416 | VendorInvestigate | 2026-Q3 | 98.36 | 3.38 | 101.8 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041603 | QSC-2606-V7416 | PeptideMeter | 2026-Q3 | 98.43 | 4.20 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041604 | QSC-2606-V7416 | VendorInvestigate | 2026-Q3 | 97.89 | 3.60 | 95.0 | Buyer-sourced | 1 | FAIL |
| AX-2026-041605 | QSC-2606-V7416 | PeptideMeter | 2026-Q3 | 97.96 | 3.59 | 102.5 | Laboratory-retained | 1 | FAIL |
| AX-2026-041606 | QSC-2606-V7416 | Janoshik | 2026-Q3 | 98.03 | 3.58 | — | Buyer-sourced | 1 | MARGINAL |
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-2026-041599 | CJC-1295 (no DAC) | QSC-2606-V7416 | VendorInvestigate | 2026-Q3 | 97.96 | 3.52 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-041601 | CJC-1295 (no DAC) | QSC-2606-V7416 | Kestrel | 2026-Q3 | 98.33 | 4.10 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041602 | CJC-1295 (no DAC) | QSC-2606-V7416 | VendorInvestigate | 2026-Q3 | 98.36 | 3.38 | 101.8 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041477 | Triptorelin | QSC-2607-C5749 | Nordanalyt | 2026-Q3 | 99.53 | 3.42 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041603 | CJC-1295 (no DAC) | QSC-2606-V7416 | PeptideMeter | 2026-Q3 | 98.43 | 4.20 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041606 | CJC-1295 (no DAC) | QSC-2606-V7416 | Janoshik | 2026-Q3 | 98.03 | 3.58 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041585 | Liraglutide | QSC-2605-W7381 | Medutest | 2026-Q3 | 99.59 | 5.09 | 92.8 | Laboratory-retained | 0 | PASS |
| AX-2026-041586 | Liraglutide | QSC-2605-W7381 | Janoshik | 2026-Q3 | 98.85 | 6.00 | 90.7 | Buyer-sourced | 0 | PASS |