A certification says what a process is supposed to do. A retail vial says what it did. Both are worth having and only one of them is a measurement.
AX-2024-004716
Oxytocin · 2 mg declared · Hunan Aslsen Technology Co., Ltd. · lot HOMO-2405-U3389
FAILIDENTITY CONSISTENT
- Report ID
- AX-2024-004716
- Compound
- Oxytocin
- Compound class
- Hypothalamic and posterior-pituitary hormones
- Supplier
- Homopeptide — Hunan Aslsen Technology Co., Ltd.
- Batch / lot
- HOMO-2405-U3389
- Declared label claim
- 2mg
- Laboratory
- Janoshik Analytical
- Assay date
- 07 Jul 2024
- Submitted
- 29 Jul 2024
- Quarter
- 2024-Q3
- Submitter
- m.halvorsen
- Sample provenance
- Buyer-sourced
Section 1
Results
Measured against the index acceptance specification for the hypothalamic and posterior-pituitary hormones 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 | 99.93 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.07 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — deamidated Gln4 (+1 Da) | 0.04 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 1006.4365 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 1006.4373 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +0.8 | ppm | ± 15 | PASS |
| Peptide content | not ordered on this submission | not determined | — | required to check label claim | NOT TESTED |
| Water content | Karl Fischer, coulometric, duplicate | 5.57 | % | ≤ 8.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 4.84 | % | ≤ 10.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.32 | % | — | NOT TESTED |
| Endotoxin | not ordered on this submission | not determined | — | ≤ 5.0 | NOT TESTED |
| Sterility | membrane filtration, USP <71>, 14 d | Growth detected at 6 d — Bacillus sp. | — | no growth | FAIL |
| 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 | 3.95 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 7.96 | min | 7.92 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.25 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 66,047 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs deamidated Gln4 (+1 Da) | 1.73 | — | no index criterion | REPORTED |
Section 2
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 | Oxytocin — main peak | 7.96 | 4,856,908 | 99.93 | — |
| 2 | deamidated Gln4 (+1 Da) | 7.74 | 1,944 | 0.04 | +0.984 |
| 3 | des-Gly9 (−57 Da) | 7.66 | 1,458 | 0.03 | -57.021 |
| 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.
Section 3
Mass spectrum and identity
Theoretical monoisotopic mass 1006.4365 Da, computed from C43H66N12O12S2. 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 (%) |
|---|---|---|---|---|
| 3+ | 336.4861 | 336.4864 | 0.0003 | 7.9 |
| 2+ | 504.2255 | 504.2259 | 0.0004 | 57.0 |
| 1+ | 1007.4438 | 1007.4446 | 0.0008 | 100.0 |
Section 4
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.
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) | 99.73 | 99.93 | divergence -0.20 pp vs batch median |
| Total impurities (% area) | 0.27 | 0.07 | |
| Largest single impurity (% area) | not stated | 0.04 | |
| Water (%) | 5.5 | 5.57 | |
| Counter-ion (%) | not stated | 4.84 | |
| Peptide content (%w/w) | not stated | not determined | |
| Endotoxin (EU/mg) | 4.09 | not determined | |
| Method stated on certificate | NO | — | no method section — the result cannot be reconciled against any other |
Section 5
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 (26 d) → laboratory (courier, cold pack, 11 d) → assay.
- Assay date
- 07 Jul 2024
- Submitted to the index
- 29 Jul 2024
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- IDENTITY CONSISTENT
Section 6
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.
Anyone can generate one of these. That is the argument the index makes on its submission page and it is the reason the dataset grows without any supplier's cooperation.
The certificate for HOMO-2405-U3389 carries what it carries. Asking for an endotoxin figure at the point of order is a normal request and it is usually met.
Section 7
Related records
Same batch — lot HOMO-2405-U3389 n=14
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-004706 | HOMO-2405-U3389 | Janoshik | 2024-Q3 | 99.93 | 5.57 | 104.1 | Buyer-sourced | 0 | PASS |
| AX-2024-004707 | HOMO-2405-U3389 | Janoshik | 2024-Q3 | 99.93 | 6.28 | 94.4 | Buyer-sourced | 0 | PASS |
| AX-2024-004708 | HOMO-2405-U3389 | Janoshik | 2024-Q3 | 99.93 | 5.74 | 90.4 | Buyer-sourced | 1 | FAIL |
| AX-2024-004709 | HOMO-2405-U3389 | Janoshik | 2024-Q3 | 99.93 | 5.12 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004710 | HOMO-2405-U3389 | Janoshik | 2024-Q3 | 99.93 | 6.56 | 101.4 | Buyer-sourced | 0 | PASS |
| AX-2024-004711 | HOMO-2405-U3389 | Nordanalyt | 2024-Q3 | 99.92 | 5.88 | 104.0 | Buyer-sourced | 0 | PASS |
| AX-2024-004712 | HOMO-2405-U3389 | VendorInvestigate | 2024-Q3 | 99.73 | 6.24 | 92.2 | Buyer-sourced | 0 | PASS |
| AX-2024-004713 | HOMO-2405-U3389 | VendorInvestigate | 2024-Q3 | 99.63 | 5.73 | 102.3 | Laboratory-retained | 0 | PASS |
| AX-2024-004714 | HOMO-2405-U3389 | Nordanalyt | 2024-Q3 | 99.93 | 6.78 | 105.5 | Supplier-supplied | 0 | PASS |
| AX-2024-004715 | HOMO-2405-U3389 | Janoshik | 2024-Q3 | 99.93 | 6.44 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004717 | HOMO-2405-U3389 | Medutest | 2024-Q3 | 99.86 | 6.13 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004718 | HOMO-2405-U3389 | Janoshik | 2024-Q3 | 99.93 | 6.05 | — | Buyer-sourced | 0 | PASS |
| AX-2024-004719 | HOMO-2405-U3389 | Medutest | 2024-Q3 | 99.73 | 5.50 | — | Buyer-sourced | 1 | MARGINAL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041398 | QYB | QYB-2601-V4429 | Medutest | 2026-Q2 | 99.60 | 4.73 | 91.8 | Buyer-sourced | 0 | PASS |
| AX-2026-041400 | QYB | QYB-2601-V4429 | Medutest | 2026-Q2 | 99.51 | 4.55 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041393 | QYB | QYB-2601-V4429 | PeptideMeter | 2026-Q2 | 99.69 | 4.63 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041395 | QYB | QYB-2601-V4429 | Janoshik | 2026-Q2 | 99.93 | 4.24 | 101.7 | Buyer-sourced | 0 | PASS |
| AX-2026-041950 | AMB | AMB-2602-G4870 | Janoshik | 2026-Q2 | 99.82 | 3.21 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041397 | QYB | QYB-2601-V4429 | Janoshik | 2026-Q2 | 99.62 | 4.38 | 102.8 | Buyer-sourced | 0 | PASS |
| AX-2026-041396 | QYB | QYB-2601-V4429 | PeptideMeter | 2026-Q2 | 99.69 | 3.97 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041394 | QYB | QYB-2601-V4429 | Medutest | 2026-Q2 | 99.66 | 5.17 | — | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042437 | Retatrutide | HOMO-2605-V4718 | Nordanalyt | 2026-Q3 | 98.68 | 3.67 | 102.8 | Buyer-sourced | 0 | PASS |
| AX-2026-042424 | Semaglutide | HOMO-2604-X3806 | PeptideMeter | 2026-Q3 | 98.85 | 4.87 | 92.0 | Buyer-sourced | 0 | PASS |
| AX-2026-042503 | IGF-1 LR3 | HOMO-2607-P5131 | Janoshik | 2026-Q3 | 99.36 | 5.99 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042492 | SS-31 (Elamipretide) | HOMO-2604-D5484 | Medutest | 2026-Q3 | 99.93 | 2.40 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042491 | SS-31 (Elamipretide) | HOMO-2604-D5484 | Kestrel | 2026-Q3 | 99.93 | 3.24 | — | Supplier-supplied | 0 | PASS |
| AX-2026-042473 | LL-37 | HOMO-2602-G5165 | Janoshik | 2026-Q3 | 99.01 | 5.00 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042441 | Retatrutide | HOMO-2605-V4718 | Medutest | 2026-Q3 | 98.93 | 4.22 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042474 | LL-37 | HOMO-2602-G5165 | Janoshik | 2026-Q3 | 99.18 | 5.44 | — | Buyer-sourced | 0 | PASS |