AssayIndex

AX-2025-020255

Enclomiphene citrate · 12.5 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2410-S2226

FAILPARTIAL
Report ID
AX-2025-020255
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
PeptideMeter
Assay date
27 Mar 2025
Submitted
01 Apr 2025
Quarter
2025-Q1
Submitter
k.guerrero
Sample provenance
Buyer-sourced
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.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 28 min gradient, 214 nm98.30% area≥ 98.5FAIL
Total impuritiesRP-HPLC, sum of reported peaks1.70% area≤ 1.5FAIL
Largest single impurityRP-HPLC — N-oxide (+16 Da)1.06% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula597.2130Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)597.2140Da—NOT TESTED
Mass accuracyobserved vs theoretical+1.7ppm± 10PASS
Total peptide contentby difference from the gravimetric mass balance65.66%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity64.54%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen17.55mg12.5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content11.327mg12.5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim90.6%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.05%≤ 10.0PASS
Counter-ion (citrate)anion-exchange ion chromatography29.51%≤ 12.0FAIL
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.78%—NOT TESTED
Endotoxinnot ordered on this submissionnot determined—≤ 5.0NOT TESTED
Sterilitynot ordered on this submissionnot determined—no growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite lyophilised cake, intact—white to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.06—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient15.47min15.43 ± 0.35 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.11—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²61,392—≥ 20,000PASS
Resolution to nearest impurityvs free base (des-citrate)0.07—no index criterionREPORTED
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.

01729345851876917 Enclomiphene citrate15.47 min · 98.30 % 14.65 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 051015202530 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 28 min gradient, 214 nm. Drawn from the peak-integration table below: peak positions are the reported retention times, peak areas are the reported area percentages, peak widths follow the reported plate count of 61,392, and skew follows the reported asymmetry factor of 1.11. Baseline noise is seeded from the report ID and is illustrative. The lower panel is the same trace at a stated vertical expansion with the slow gradient drift subtracted, because at full scale a 1.06 % impurity against a 98.30 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Enclomiphene citrate — main peak15.474,777,68598.30—
2N-oxide (+16 Da)14.6551,5191.06+15.995
3des-ethyl enclomiphene (−28 Da)15.0620,4130.42-28.031
4zuclomiphene (cis-isomer)14.895,8320.120.000
5free base (des-citrate)15.494,8600.10-192.027
Closure check — purity + Σ impurities 100.00CLOSES

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 597.2130 Da, computed from C26H28ClNO · C6H8O7. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100550575600625650675 [M+1H]1+598.22 m/z Relative abundance (%)
Figure 2. ESI charge-state envelope, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 597.2140 Da. Sodium (+21.982/z) and potassium (+37.956/z) adducts are shown where the parent charge state exceeds 25 % relative abundance; they are adducts of the same molecule and are not impurities.
ChargeTheoretical m/zObserved m/zΔ m/zRel. abundance (%)
1+598.2203598.22130.0010100.0
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.

ComponentDetermination%w/w of cake
WaterKarl Fischer4.05
Counter-ion (citrate)ion chromatography29.51
Residual solvent + inorganic residueestimated0.78
Total peptide contentby difference65.66
Total100.00 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.

FigureSupplier COAThis reportIndex note
Purity (% area)98.6098.30divergence +0.33 pp vs batch median
Total impurities (% area)1.401.70
Largest single impurity (% area)0.871.06
Water (%)3.04.05
Counter-ion (%)7.329.51
Peptide content (%w/w)89.165.66
Endotoxin (EU/mg)not statednot determined
Method stated on certificateNO—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
Domestic warehouse despatch → submitter (2–8 °C, 26 d) → laboratory (courier, cold pack, 7 d) → assay.
Assay date
27 Mar 2025
Submitted to the index
01 Apr 2025
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 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.

wide_iqr
98.30 % on Enclomiphene citrate is below the index specification for the class. The interesting part is the distribution: N-oxide (+16 Da) at 1.06 % is doing most of the work, and that species is a synthesis artefact rather than a degradation product. This is a process observation about lot GGPE-2410-S2226, not a storage one.
coa_template
The document that arrived with this order is on file and its fields are scored on the supplier's documentation rubric. That score describes what a buyer receives, which is the useful version.
method_absent
A resolution figure without a stated column and gradient is uninterpretable. Both are on this record, which is why the figure is worth printing at all.
gradient_25
Gradient length belongs on every certificate. On a close-eluting pair it is not a detail, it is the whole determination.
Section 7

Related records

Same batch — lot GGPE-2410-S2226 n=13

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020252GGPE-2410-S2226Janoshik2025-Q198.093.8895.3Laboratory-retained0FAIL
AX-2025-020253GGPE-2410-S2226Nordanalyt2025-Q198.843.91107.1Supplier-supplied0FAIL
AX-2025-020254GGPE-2410-S2226Medutest2025-Q198.473.35—Buyer-sourced1FAIL
AX-2025-020256GGPE-2410-S2226Nordanalyt2025-Q198.354.1689.7Buyer-sourced1FAIL
AX-2025-020257GGPE-2410-S2226Medutest2025-Q198.033.71—Buyer-sourced0FAIL
AX-2025-020258GGPE-2410-S2226Janoshik2025-Q198.443.7697.1Buyer-sourced0FAIL
AX-2025-020259GGPE-2410-S2226Medutest2025-Q198.944.0298.6Supplier-supplied0FAIL
AX-2025-020260GGPE-2410-S2226Janoshik2025-Q198.273.70—Buyer-sourced0FAIL
AX-2025-020261GGPE-2410-S2226VendorInvestigate2025-Q197.743.73—Buyer-sourced0FAIL
AX-2025-020262GGPE-2410-S2226Medutest2025-Q198.124.2796.1Buyer-sourced0FAIL
AX-2025-020263GGPE-2410-S2226Janoshik2025-Q198.123.85101.5Buyer-sourced0FAIL
AX-2025-020264GGPE-2410-S2226Janoshik2025-Q198.273.9994.6Buyer-sourced0FAIL

Cross-sections

Other recent Enclomiphene citrate records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041525QSCQSC-2604-R6644PeptideMeter2026-Q299.804.04101.5Laboratory-retained0FAIL
AX-2026-042329TFCTFC-2605-H2745Nordanalyt2026-Q299.413.67—Buyer-sourced2FAIL
AX-2026-041524QSCQSC-2604-R6644PeptideMeter2026-Q299.934.6091.6Buyer-sourced0FAIL
AX-2026-041526QSCQSC-2604-R6644Medutest2026-Q299.684.25103.7Buyer-sourced1FAIL
AX-2026-043164SSASSA-2603-C7061Kestrel2026-Q298.483.27107.4Buyer-sourced2FAIL
AX-2026-041773ASYASY-{CAT}-1806Janoshik2025-Q499.883.59—Buyer-sourced1FAIL
AX-2025-019360HYBHYB-2510-J6404Medutest2025-Q499.615.0798.1Laboratory-retained0FAIL
AX-2025-018986ASYASY-{CAT}-1806Medutest2025-Q499.933.35—Buyer-sourced1FAIL
Other recent GGPeps records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042784CJC-1295 (no DAC)GGPE-2606-E1234Medutest2026-Q398.274.55—Buyer-sourced0PASS
AX-2026-042786CJC-1295 (no DAC)GGPE-2606-E1234Janoshik2026-Q398.223.77—Buyer-sourced0PASS
AX-2026-042858SelankGGPE-2603-J2447VendorInvestigate2026-Q398.878.8599.4Buyer-sourced0FAIL
AX-2026-042783CJC-1295 (no DAC)GGPE-2606-E1234Janoshik2026-Q398.224.4590.6Buyer-sourced0PASS
AX-2026-042757Melanotan IIGGPE-2603-P1474Janoshik2026-Q399.546.7892.0Buyer-sourced0PASS
AX-2026-042785CJC-1295 (no DAC)GGPE-2606-E1234PeptideMeter2026-Q397.704.6491.4Buyer-sourced0FAIL
AX-2026-042756Melanotan IIGGPE-2603-P1474Nordanalyt2026-Q399.177.04—Buyer-sourced0PASS
AX-2026-042755Melanotan IIGGPE-2603-P1474Nordanalyt2026-Q399.256.5890.4Buyer-sourced0PASS