AssayIndex

AX-2025-020256

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

FAILPARTIAL
Report ID
AX-2025-020256
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
Nordanalyt Laboratories
Assay date
31 Jan 2025
Submitted
04 Feb 2025
Quarter
2025-Q1
Submitter
void_marker
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, 35 min gradient, 214 nm98.35% area≥ 98.5FAIL
Total impuritiesRP-HPLC, sum of reported peaks1.65% area≤ 1.5FAIL
Largest single impurityRP-HPLC — zuclomiphene (cis-isomer)1.10% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula597.2130Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)597.2153Da—NOT TESTED
Mass accuracyobserved vs theoretical+3.8ppm± 10PASS
Total peptide contentby difference from the gravimetric mass balance62.81%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity61.77%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen18.16mg12.5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content11.217mg12.5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim89.7%90.0 – 110.0FAIL
Water contentKarl Fischer, coulometric, duplicate4.16%≤ 10.0PASS
Counter-ion (citrate)anion-exchange ion chromatography32.13%≤ 12.0FAIL
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.90%—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 calibration4.39—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient19.03min18.96 ± 0.35 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.04—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²75,978—≥ 20,000PASS
Resolution to nearest impurityvs free base (des-citrate)0.08—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.

01622324448656487 Enclomiphene citrate19.03 min · 98.35 % 18.31 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0510152025303540 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 35 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 75,978, and skew follows the reported asymmetry factor of 1.04. 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 1.10 % impurity against a 98.35 % 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 peak19.034,780,11598.35—
2zuclomiphene (cis-isomer)18.3153,4631.100.000
3free base (des-citrate)19.0516,0390.33-192.027
4N-oxide (+16 Da)18.007,2900.15+15.995
5des-ethyl enclomiphene (−28 Da)18.523,4020.07-28.031
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 597.2153 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+598.2203598.22260.0023100.0
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 Fischer4.16
Counter-ion (citrate)ion chromatography32.13
Residual solvent + inorganic residueestimated0.90
Total peptide contentby difference62.81
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)98.6098.35divergence +0.33 pp vs batch median
Total impurities (% area)1.401.65
Largest single impurity (% area)0.871.10
Water (%)3.04.16
Counter-ion (%)7.332.13
Peptide content (%w/w)89.162.81
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, 5 d) → laboratory (courier, cold pack, 2 d) → assay.
Assay date
31 Jan 2025
Submitted to the index
04 Feb 2025
Laboratory
Nordanalyt Laboratories, Uppsala, Sweden
Method basis
35 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.

uncertainty_budget
The gap between 98.35 % and the class specification should be read against an expanded uncertainty of roughly ±0.5 pp. A shortfall inside that band is not a finding; a shortfall well outside it is.
baseline_noise
On a low-resolution pair the baseline between the peaks never reaches baseline, so any integration is an extrapolation. Stating which extrapolation was used is worth more than any threshold.
plate_count
Where the plate count is low the resolution figure is low for a reason that has nothing to do with the impurity profile. Read the two together or read neither.
counterion_mol
The stoichiometric prediction and the measured figure agree closely enough on this record that no excess reagent need be postulated. That is a quiet, useful result.
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-2025-020255GGPE-2410-S2226PeptideMeter2025-Q198.304.0590.6Buyer-sourced0FAIL
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