A beta-aspartyl isomer sits a tenth of a minute away and is mass-identical. That is the archetype of a pair where resolution is a compound property and no rule should adjudicate it.
AX-2025-020252
Enclomiphene citrate · 12.5 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2410-S2226
FAILPARTIAL
- Report ID
- AX-2025-020252
- Compound
- Enclomiphene citrate
- Compound class
- Non-peptide adjuncts
- Supplier
- GGPeps — Nantong Guangyuan Chemical Co., Ltd.
- Batch / lot
- GGPE-2410-S2226
- Declared label claim
- 13mg
- Laboratory
- Janoshik Analytical
- Assay date
- 19 Jan 2025
- Submitted
- 21 Jan 2025
- Quarter
- 2025-Q1
- Submitter
- am.weiss
- Sample provenance
- Laboratory-retained
Section 1
Results
Measured against the index acceptance specification for the non-peptide adjuncts 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 | 98.09 | % area | ≥ 98.5 | FAIL |
| Total impurities | RP-HPLC, sum of reported peaks | 1.91 | % area | ≤ 1.5 | FAIL |
| Largest single impurity | RP-HPLC — zuclomiphene (cis-isomer) | 1.27 | % area | ≤ 1.00 | FAIL |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 67.82 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 66.52 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 17.91 | mg | 12.5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 11.914 | mg | 12.5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 95.3 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 3.88 | % | ≤ 10.0 | PASS |
| Counter-ion (citrate) | anion-exchange ion chromatography | 27.60 | % | ≤ 12.0 | FAIL |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.70 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.53 | 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 | 4.41 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 16.29 | min | 16.44 ± 0.35 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.99 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 54,449 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs free base (des-citrate) | 0.07 | — | 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 | Enclomiphene citrate — main peak | 16.29 | 4,767,478 | 98.09 | — |
| 2 | zuclomiphene (cis-isomer) | 15.67 | 61,726 | 1.27 | 0.000 |
| 3 | free base (des-citrate) | 16.31 | 18,469 | 0.38 | -192.027 |
| 4 | N-oxide (+16 Da) | 15.41 | 8,263 | 0.17 | +15.995 |
| 5 | des-ethyl enclomiphene (−28 Da) | 15.85 | 4,374 | 0.09 | -28.031 |
| 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 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.
| Component | Determination | %w/w of cake |
|---|---|---|
| Water | Karl Fischer | 3.88 |
| Counter-ion (citrate) | ion chromatography | 27.60 |
| Residual solvent + inorganic residue | estimated | 0.70 |
| Total peptide content | by difference | 67.82 |
| 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) | 98.60 | 98.09 | divergence +0.33 pp vs batch median |
| Total impurities (% area) | 1.40 | 1.91 | |
| Largest single impurity (% area) | 0.87 | 1.27 | |
| Water (%) | 3.0 | 3.88 | |
| Counter-ion (%) | 7.3 | 27.60 | |
| Peptide content (%w/w) | 89.1 | 67.82 | |
| Endotoxin (EU/mg) | not stated | 0.53 | |
| 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
- Laboratory-retained
- Evidentiary weight
- Provenance documented, selection uncontrolled.
- Chain of custody
- Laboratory retained sample (−20 °C, 12 d since original receipt) → re-assay.
- Assay date
- 19 Jan 2025
- Submitted to the index
- 21 Jan 2025
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- PARTIAL
Section 6
Annotations 4
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.
A specification for counter-ion content, stated with a method, would make this field checkable. Most certificates name the salt and stop there.
Residual solvents sit in the same slot on the mass balance as counter-ion in a poorly specified certificate. Headspace gas chromatography separates the two and is rarely ordered.
The supplier's own declaration is printed beside the index's balance on this page. Comparing the two is the point of publishing both and rule AX-R07 is about the comparison.
Section 7
Related records
Same batch — lot GGPE-2410-S2226 n=13
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-020253 | GGPE-2410-S2226 | Nordanalyt | 2025-Q1 | 98.84 | 3.91 | 107.1 | Supplier-supplied | 0 | FAIL |
| AX-2025-020254 | GGPE-2410-S2226 | Medutest | 2025-Q1 | 98.47 | 3.35 | — | Buyer-sourced | 1 | FAIL |
| AX-2025-020255 | GGPE-2410-S2226 | PeptideMeter | 2025-Q1 | 98.30 | 4.05 | 90.6 | Buyer-sourced | 0 | FAIL |
| AX-2025-020256 | GGPE-2410-S2226 | Nordanalyt | 2025-Q1 | 98.35 | 4.16 | 89.7 | Buyer-sourced | 1 | FAIL |
| AX-2025-020257 | GGPE-2410-S2226 | Medutest | 2025-Q1 | 98.03 | 3.71 | — | Buyer-sourced | 0 | FAIL |
| AX-2025-020258 | GGPE-2410-S2226 | Janoshik | 2025-Q1 | 98.44 | 3.76 | 97.1 | Buyer-sourced | 0 | FAIL |
| AX-2025-020259 | GGPE-2410-S2226 | Medutest | 2025-Q1 | 98.94 | 4.02 | 98.6 | Supplier-supplied | 0 | FAIL |
| AX-2025-020260 | GGPE-2410-S2226 | Janoshik | 2025-Q1 | 98.27 | 3.70 | — | Buyer-sourced | 0 | FAIL |
| AX-2025-020261 | GGPE-2410-S2226 | VendorInvestigate | 2025-Q1 | 97.74 | 3.73 | — | Buyer-sourced | 0 | FAIL |
| AX-2025-020262 | GGPE-2410-S2226 | Medutest | 2025-Q1 | 98.12 | 4.27 | 96.1 | Buyer-sourced | 0 | FAIL |
| AX-2025-020263 | GGPE-2410-S2226 | Janoshik | 2025-Q1 | 98.12 | 3.85 | 101.5 | Buyer-sourced | 0 | FAIL |
| AX-2025-020264 | GGPE-2410-S2226 | Janoshik | 2025-Q1 | 98.27 | 3.99 | 94.6 | Buyer-sourced | 0 | FAIL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041525 | QSC | QSC-2604-R6644 | PeptideMeter | 2026-Q2 | 99.80 | 4.04 | 101.5 | Laboratory-retained | 0 | FAIL |
| AX-2026-042329 | TFC | TFC-2605-H2745 | Nordanalyt | 2026-Q2 | 99.41 | 3.67 | — | Buyer-sourced | 2 | FAIL |
| AX-2026-041524 | QSC | QSC-2604-R6644 | PeptideMeter | 2026-Q2 | 99.93 | 4.60 | 91.6 | Buyer-sourced | 0 | FAIL |
| AX-2026-041526 | QSC | QSC-2604-R6644 | Medutest | 2026-Q2 | 99.68 | 4.25 | 103.7 | Buyer-sourced | 1 | FAIL |
| AX-2026-043164 | SSA | SSA-2603-C7061 | Kestrel | 2026-Q2 | 98.48 | 3.27 | 107.4 | Buyer-sourced | 2 | FAIL |
| AX-2026-041773 | ASY | ASY-{CAT}-1806 | Janoshik | 2025-Q4 | 99.88 | 3.59 | — | Buyer-sourced | 1 | FAIL |
| AX-2025-019360 | HYB | HYB-2510-J6404 | Medutest | 2025-Q4 | 99.61 | 5.07 | 98.1 | Laboratory-retained | 0 | FAIL |
| AX-2025-018986 | ASY | ASY-{CAT}-1806 | Medutest | 2025-Q4 | 99.93 | 3.35 | — | Buyer-sourced | 1 | FAIL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042784 | CJC-1295 (no DAC) | GGPE-2606-E1234 | Medutest | 2026-Q3 | 98.27 | 4.55 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042786 | CJC-1295 (no DAC) | GGPE-2606-E1234 | Janoshik | 2026-Q3 | 98.22 | 3.77 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042858 | Selank | GGPE-2603-J2447 | VendorInvestigate | 2026-Q3 | 98.87 | 8.85 | 99.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042783 | CJC-1295 (no DAC) | GGPE-2606-E1234 | Janoshik | 2026-Q3 | 98.22 | 4.45 | 90.6 | Buyer-sourced | 0 | PASS |
| AX-2026-042757 | Melanotan II | GGPE-2603-P1474 | Janoshik | 2026-Q3 | 99.54 | 6.78 | 92.0 | Buyer-sourced | 0 | PASS |
| AX-2026-042785 | CJC-1295 (no DAC) | GGPE-2606-E1234 | PeptideMeter | 2026-Q3 | 97.70 | 4.64 | 91.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042756 | Melanotan II | GGPE-2603-P1474 | Nordanalyt | 2026-Q3 | 99.17 | 7.04 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042755 | Melanotan II | GGPE-2603-P1474 | Nordanalyt | 2026-Q3 | 99.25 | 6.58 | 90.4 | Buyer-sourced | 0 | PASS |