AssayIndex

AX-2025-020258

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

FAILPARTIAL
Report ID
AX-2025-020258
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
26 Jan 2025
Submitted
13 Feb 2025
Quarter
2025-Q1
Submitter
k.wojcik
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, 30 min gradient, 214 nm98.44% area≥ 98.5FAIL
Total impuritiesRP-HPLC, sum of reported peaks1.56% area≤ 1.5FAIL
Largest single impurityRP-HPLC — zuclomiphene (cis-isomer)1.04% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula597.2130Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)597.2122Da—NOT TESTED
Mass accuracyobserved vs theoretical-1.3ppm± 10PASS
Total peptide contentby difference from the gravimetric mass balance62.40%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity61.43%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen19.76mg12.5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content12.139mg12.5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim97.1%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate3.76%≤ 10.0PASS
Counter-ion (citrate)anion-exchange ion chromatography33.27%≤ 12.0FAIL
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.57%—NOT TESTED
Endotoxinkinetic chromogenic LAL0.51EU/mg≤ 5.0PASS
Sterilitynot ordered on this submissionnot determined—no growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite cake, partially collapsed—white to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.94—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient16.52min16.44 ± 0.35 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.94—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²84,633—≥ 20,000PASS
Resolution to nearest impurityvs free base (des-citrate)0.09—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.

02075415062258299 Enclomiphene citrate16.52 min · 98.44 % 15.90 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 30 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 84,633, and skew follows the reported asymmetry factor of 0.94. 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 1.04 % impurity against a 98.44 % 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 peak16.524,784,48998.44—
2zuclomiphene (cis-isomer)15.9050,5471.040.000
3free base (des-citrate)16.5415,0670.31-192.027
4N-oxide (+16 Da)15.646,8040.14+15.995
5des-ethyl enclomiphene (−28 Da)16.083,4020.07-28.031
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 597.2122 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+598.2203598.2195-0.0008100.0
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 Fischer3.76
Counter-ion (citrate)ion chromatography33.27
Residual solvent + inorganic residueestimated0.57
Total peptide contentby difference62.40
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)98.6098.44divergence +0.33 pp vs batch median
Total impurities (% area)1.401.56
Largest single impurity (% area)0.871.04
Water (%)3.03.76
Counter-ion (%)7.333.27
Peptide content (%w/w)89.162.40
Endotoxin (EU/mg)not stated0.51
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
Retail purchase → submitter (ambient, 26 d) → laboratory (courier, cold pack, 8 d) → assay.
Assay date
26 Jan 2025
Submitted to the index
13 Feb 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.

quad_unit
Instrument class is on the record, which is what allows -1.3 ppm to be read at its proper weight. The index distinguishes "confirmed" from "consistent with" precisely on this field.
ppm_error
Well inside class limit. Worth noting that the class limits are set by mass rather than globally, because the same ppm is a different number of daltons at 340 and at 4,800.
sample_vs_retail
A retail vial at 98.44 % is worth more evidentially than a selected vial at a higher figure. That is the whole argument for recording provenance at all.
gradient_25
Resolution scales with the square root of plate count and linearly with selectivity. Shallowing the gradient changes selectivity, which is the more effective of the two levers on a close pair.
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-2025-020256GGPE-2410-S2226Nordanalyt2025-Q198.354.1689.7Buyer-sourced1FAIL
AX-2025-020257GGPE-2410-S2226Medutest2025-Q198.033.71—Buyer-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