AX-2026-043425
CJC-1295 (no DAC) · 10 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2601-P4636
- Report ID
- AX-2026-043425
- Compound
- CJC-1295 (no DAC)
- Compound class
- Growth-hormone axis peptides
- Supplier
- WXT — WuXi TIDES (WuXi AppTec Testing Division)
- Batch / lot
- WXT-2601-P4636
- Declared label claim
- 10mg
- Laboratory
- VendorInvestigate
- Assay date
- 06 Feb 2026
- Submitted
- 11 Feb 2026
- Quarter
- 2026-Q1
- Submitter
- s.marchetti
- 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, 32 min gradient, 214 nm | 98.24 | % area | ≥ 98.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.76 | % area | ≤ 2.0 | PASS |
| Largest single impurity | RP-HPLC — deamidated (+1 Da) | 0.70 | % 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) | 3365.7405 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +0.1 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 88.89 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 87.33 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 10.92 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 9.536 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 95.4 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.90 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 4.82 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.39 | % | — | 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 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 | 6.05 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 32 min gradient | 13.61 | min | 13.65 ± 0.30 (normalised) | PASS |
| 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 | 52,093 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs deamidated (+1 Da) | 1.05 | — | 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 | 13.61 | 4,774,769 | 98.24 | — |
| 2 | deamidated (+1 Da) | 13.35 | 34,022 | 0.70 | +0.984 |
| 3 | des-Tyr1 (−163 Da) | 13.03 | 22,843 | 0.47 | -163.063 |
| 4 | truncated (1-24) | 12.37 | 18,955 | 0.39 | -570.291 |
| 5 | native GRF (1-29) (−59 Da) | 13.25 | 5,832 | 0.12 | -58.995 |
| 6 | acetyl adduct (+42 Da) | 14.08 | 3,888 | 0.08 | +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 | 674.1554 | 0.0001 | 8.1 |
| 4+ | 842.4423 | 842.4424 | 0.0001 | 53.0 |
| 3+ | 1122.9207 | 1122.9208 | 0.0001 | 100.0 |
| 2+ | 1683.8774 | 1683.8775 | 0.0001 | 59.8 |
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 | 5.90 |
| Counter-ion (acetate) | ion chromatography | 4.82 |
| Residual solvent + inorganic residue | estimated | 0.39 |
| Total peptide content | by difference | 88.89 |
| 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) | 98.47 | 98.24 | divergence +0.32 pp vs batch median |
| Total impurities (% area) | 1.53 | 1.76 | |
| Largest single impurity (% area) | 0.96 | 0.70 | |
| Water (%) | 4.9 | 5.90 | |
| Counter-ion (%) | not stated | 4.82 | |
| Peptide content (%w/w) | 90.3 | 88.89 | |
| Endotoxin (EU/mg) | 0.32 | 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 (−20 °C, 33 d) → laboratory (courier, dry ice, 10 d) → assay.
- Assay date
- 06 Feb 2026
- Submitted to the index
- 11 Feb 2026
- Laboratory
- VendorInvestigate, Riga, Latvia
- Method basis
- 32 min gradient · high-resolution MS
- Verification status
- VERIFIED
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot WXT-2601-P4636 n=5
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043426 | WXT-2601-P4636 | Nordanalyt | 2026-Q1 | 98.07 | 6.80 | 93.4 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043427 | WXT-2601-P4636 | Medutest | 2026-Q1 | 98.40 | 6.00 | 95.3 | Supplier-supplied | 3 | FAIL |
| AX-2026-043428 | WXT-2601-P4636 | Janoshik | 2026-Q1 | 98.15 | 6.38 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043429 | WXT-2601-P4636 | Janoshik | 2026-Q1 | 98.13 | 7.68 | — | 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-2026-042669 | GGPeps | GGPE-2606-E8495 | Medutest | 2026-Q3 | 98.61 | 4.06 | 95.5 | Supplier-supplied | 0 | PASS |
| 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 |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043488 | Pramlintide | WXT-2603-D6052 | Janoshik | 2026-Q3 | 97.87 | 4.37 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043406 | Semaglutide | WXT-2604-C4728 | Janoshik | 2026-Q3 | 97.24 | 4.65 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043421 | Sermorelin | WXT-2608-P4867 | Janoshik | 2026-Q3 | 98.15 | 3.09 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043420 | Sermorelin | WXT-2608-P4867 | Medutest | 2026-Q3 | 98.62 | 3.07 | 96.4 | Supplier-supplied | 0 | PASS |
| AX-2026-043423 | Sermorelin | WXT-2608-P4867 | Janoshik | 2026-Q3 | 98.28 | 3.86 | 98.5 | Buyer-sourced | 0 | PASS |
| AX-2026-043401 | Semaglutide | WXT-2604-C4728 | Medutest | 2026-Q3 | 97.70 | 4.78 | 91.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043400 | Semaglutide | WXT-2604-C4728 | Nordanalyt | 2026-Q3 | 96.86 | 4.11 | 106.4 | Laboratory-retained | 1 | FAIL |
| AX-2026-043422 | Sermorelin | WXT-2608-P4867 | Medutest | 2026-Q3 | 98.35 | 3.59 | — | Supplier-supplied | 1 | MARGINAL |