AX-2025-018491
CJC-1295 with DAC · 5 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2509-J2816
- Report ID
- AX-2025-018491
- Compound
- CJC-1295 with DAC
- Compound class
- Growth-hormone axis peptides
- Supplier
- WWB — Wuhan Wansheng Biotechnology Co., Ltd.
- Batch / lot
- WWB-2509-J2816
- Declared label claim
- 5mg
- Laboratory
- Medutest
- Assay date
- 12 Nov 2025
- Submitted
- 03 Dec 2025
- Quarter
- 2025-Q4
- Submitter
- as.vestergaard
- 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 | 99.33 | % area | ≥ 97.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.67 | % area | ≤ 2.5 | PASS |
| Largest single impurity | RP-HPLC — mod-GRF (1-29) (−279 Da) | 0.32 | % 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 | 91.96 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 91.34 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 4.95 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 4.521 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 90.4 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 3.57 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 3.71 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.76 | % | — | 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 | 4.98 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 12.45 | min | 12.38 ± 0.35 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.01 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 49,679 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs deamidated (+1 Da) | 0.95 | — | 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 | 12.45 | 4,827,746 | 99.33 | — |
| 2 | mod-GRF (1-29) (−279 Da) | 10.98 | 15,553 | 0.32 | -279.235 |
| 3 | maleimide dimer | 14.47 | 11,179 | 0.23 | +3644.975 |
| 4 | hydrolysed maleimide (+18 Da) | 11.93 | 3,402 | 0.07 | +18.011 |
| 5 | deamidated (+1 Da) | 12.23 | 2,430 | 0.05 | +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 | 3.57 |
| Counter-ion (acetate) | ion chromatography | 3.71 |
| Residual solvent + inorganic residue | estimated | 0.76 |
| Total peptide content | by difference | 91.96 |
| 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 | 99.33 | divergence +0.71 pp vs batch median |
| Total impurities (% area) | not stated | 0.67 | |
| Largest single impurity (% area) | not stated | 0.32 | |
| Water (%) | 2.3 | 3.57 | |
| Counter-ion (%) | not stated | 3.71 | |
| Peptide content (%w/w) | 98.9 | 91.96 | |
| 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
- Supplier-supplied
- Evidentiary weight
- Weaker evidence. Read with the caveat below.
- Chain of custody
- Supplier despatch → laboratory direct (courier, cold pack, 5 d) → assay. Submitter did not handle the vial.
- Assay date
- 12 Nov 2025
- Submitted to the index
- 03 Dec 2025
- 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 WWB-2509-J2816 n=14
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-018479 | WWB-2509-J2816 | Janoshik | 2025-Q4 | 99.07 | 3.45 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041282 | WWB-2509-J2816 | Kestrel | 2025-Q4 | 99.20 | 3.90 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018480 | WWB-2509-J2816 | Janoshik | 2025-Q4 | 99.34 | 4.19 | 105.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018481 | WWB-2509-J2816 | Kestrel | 2025-Q4 | 99.44 | 3.24 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018482 | WWB-2509-J2816 | Kestrel | 2025-Q4 | 98.67 | 3.67 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018483 | WWB-2509-J2816 | Medutest | 2025-Q4 | 99.08 | 3.57 | 99.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018484 | WWB-2509-J2816 | Nordanalyt | 2025-Q4 | 99.31 | 3.61 | 106.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018485 | WWB-2509-J2816 | PeptideMeter | 2025-Q4 | 99.14 | 4.14 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018486 | WWB-2509-J2816 | PeptideMeter | 2025-Q4 | 99.30 | 3.32 | 96.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018487 | WWB-2509-J2816 | Janoshik | 2025-Q4 | 99.14 | 4.44 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018488 | WWB-2509-J2816 | Janoshik | 2025-Q4 | 99.18 | 4.11 | 100.8 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018489 | WWB-2509-J2816 | PeptideMeter | 2025-Q4 | 99.04 | 4.12 | 93.3 | Supplier-supplied | 1 | MARGINAL |
| AX-2025-018490 | WWB-2509-J2816 | Janoshik | 2025-Q4 | 99.40 | 3.68 | 101.1 | Supplier-supplied | 1 | MARGINAL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041727 | QSC | QSC-2602-E9474 | Janoshik | 2026-Q3 | 98.88 | 6.62 | 105.3 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041728 | QSC | QSC-2602-E9474 | VendorInvestigate | 2026-Q3 | 98.42 | 7.04 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041734 | QSC | QSC-2602-E9474 | Medutest | 2026-Q3 | 99.43 | 7.17 | 105.5 | Supplier-supplied | 2 | FAIL |
| AX-2026-043539 | BCH | BCH-2607-H7307 | Janoshik | 2026-Q3 | 98.12 | 5.78 | 100.6 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041730 | QSC | QSC-2602-E9474 | PeptideMeter | 2026-Q3 | 98.79 | 6.93 | 95.4 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041731 | QSC | QSC-2602-E9474 | VendorInvestigate | 2026-Q3 | 99.07 | 7.18 | 99.6 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041725 | QSC | QSC-2602-E9474 | Medutest | 2026-Q3 | 99.06 | 7.04 | 107.3 | Supplier-supplied | 2 | FAIL |
| AX-2026-043537 | BCH | BCH-2607-H7307 | Janoshik | 2026-Q3 | 98.45 | 5.49 | 103.1 | Supplier-supplied | 1 | MARGINAL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041275 | Liraglutide | WWB-2607-X2189 | Nordanalyt | 2026-Q3 | 99.61 | 5.03 | 97.3 | Supplier-supplied | 0 | PASS |
| AX-2026-041387 | BPC-157 | WWB-2606-H3906 | Janoshik | 2026-Q3 | 98.95 | 4.64 | — | Laboratory-retained | 1 | MARGINAL |
| AX-2026-041334 | Semaglutide | WWB-2606-N3192 | Janoshik | 2026-Q3 | 98.83 | 5.04 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041337 | Semaglutide | WWB-2606-N3192 | Nordanalyt | 2026-Q3 | 98.96 | 4.81 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041385 | BPC-157 | WWB-2606-H3906 | Medutest | 2026-Q3 | 99.31 | 4.31 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041390 | BPC-157 | WWB-2606-H3906 | Medutest | 2026-Q3 | 99.47 | 4.84 | 99.3 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041386 | BPC-157 | WWB-2606-H3906 | VendorInvestigate | 2026-Q3 | 99.32 | 4.88 | 99.2 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041335 | Semaglutide | WWB-2606-N3192 | Janoshik | 2026-Q3 | 99.55 | 4.55 | 100.5 | Supplier-supplied | 1 | MARGINAL |