AssayIndex

AX-2025-020253

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

FAILPARTIAL
Report ID
AX-2025-020253
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
07 Mar 2025
Submitted
15 Mar 2025
Quarter
2025-Q1
Submitter
a.sobczak
Sample provenance
Supplier-supplied
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 nm98.84% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.16% area≤ 1.5PASS
Largest single impurityRP-HPLC — N-oxide (+16 Da)0.73% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula597.2130Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)597.2131Da—NOT TESTED
Mass accuracyobserved vs theoretical+0.2ppm± 10PASS
Total peptide contentby difference from the gravimetric mass balance62.01%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity61.29%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen21.84mg12.5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content13.386mg12.5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim107.1%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate3.91%≤ 10.0PASS
Counter-ion (citrate)anion-exchange ion chromatography33.25%≤ 12.0FAIL
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.83%—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 cake, partial shrinkage from vial wall—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 calibration4.68—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient19.13min18.96 ± 0.35 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.86—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²52,356—≥ 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.

01442288343255766 Enclomiphene citrate19.13 min · 98.84 % 18.10 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 52,356, and skew follows the reported asymmetry factor of 0.86. 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 0.73 % impurity against a 98.84 % 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 peak19.134,803,93098.84—
2N-oxide (+16 Da)18.1035,4800.73+15.995
3des-ethyl enclomiphene (−28 Da)18.6213,6090.28-28.031
4zuclomiphene (cis-isomer)18.413,8880.080.000
5free base (des-citrate)19.153,4020.07-192.027
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 597.2131 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+598.2203598.22040.0001100.0
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 Fischer3.91
Counter-ion (citrate)ion chromatography33.25
Residual solvent + inorganic residueestimated0.83
Total peptide contentby difference62.01
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)98.6098.84divergence +0.33 pp vs batch median
Total impurities (% area)1.401.16
Largest single impurity (% area)0.870.73
Water (%)3.03.91
Counter-ion (%)7.333.25
Peptide content (%w/w)89.162.01
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
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 8 d) → assay. Submitter did not handle the vial.
Assay date
07 Mar 2025
Submitted to the index
15 Mar 2025
Laboratory
Nordanalyt Laboratories, Uppsala, Sweden
Method basis
35 min gradient · high-resolution MS
Verification status
PARTIAL
Section 6

Annotations 2

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.

survodutide_mixup
Where two compounds elute within a third of a minute, a mass at this accuracy is what separates them. Retention alone would not have.
survivor_lots
A supplier sending a sample chooses a lot as well as a vial. Both selections point the same way and neither is separable from the other in a single record.
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-2025-020254GGPE-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-2025-020258GGPE-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