AssayIndex

AX-2025-020137

Enclomiphene citrate · 12.5 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2410-S9487

FAILPARTIAL
Report ID
AX-2025-020137
Compound
Enclomiphene citrate
Compound class
Non-peptide adjuncts
Supplier
GGPeps — Nantong Guangyuan Chemical Co., Ltd.
Batch / lot
GGPE-2410-S9487
Declared label claim
13mg
Laboratory
PeptideMeter
Assay date
12 Feb 2025
Submitted
05 Mar 2025
Quarter
2025-Q1
Submitter
Contributor #F-7028
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, 28 min gradient, 214 nm98.37% area≥ 98.5FAIL
Total impuritiesRP-HPLC, sum of reported peaks1.63% area≤ 1.5FAIL
Largest single impurityRP-HPLC — N-oxide (+16 Da)1.01% 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
Peptide contentnot ordered on this submissionnot determined—required to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate4.08%≤ 10.0PASS
Counter-ion (citrate)anion-exchange ion chromatography31.69%≤ 12.0FAIL
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.47%—NOT TESTED
Endotoxinkinetic chromogenic LAL0.53EU/mg≤ 5.0PASS
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 calibration4.79—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient15.30min15.43 ± 0.35 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.03—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²66,414—≥ 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.

01891378356747566 Enclomiphene citrate15.30 min · 98.37 % 14.48 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 66,414, and skew follows the reported asymmetry factor of 1.03. 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 1.01 % impurity against a 98.37 % 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 peak15.304,781,08798.37—
2N-oxide (+16 Da)14.4849,0891.01+15.995
3des-ethyl enclomiphene (−28 Da)14.8919,4410.40-28.031
4zuclomiphene (cis-isomer)14.725,8320.120.000
5free base (des-citrate)15.324,8600.10-192.027
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 597.2153 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.

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)98.7598.37divergence +0.45 pp vs batch median
Total impurities (% area)1.251.63
Largest single impurity (% area)0.761.01
Water (%)3.24.08
Counter-ion (%)8.731.69
Peptide content (%w/w)87.5not determined
Endotoxin (EU/mg)not stated0.53
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, 9 d) → assay. Submitter did not handle the vial.
Assay date
12 Feb 2025
Submitted to the index
05 Mar 2025
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 min gradient · high-resolution MS
Verification status
PARTIAL
Section 6

Annotations

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot GGPE-2410-S9487 n=7

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020136GGPE-2410-S9487Janoshik2025-Q198.303.63103.3Supplier-supplied1FAIL
AX-2025-020138GGPE-2410-S9487Janoshik2025-Q198.633.77—Supplier-supplied1FAIL
AX-2025-020139GGPE-2410-S9487Janoshik2025-Q197.954.26105.1Supplier-supplied1FAIL
AX-2025-020140GGPE-2410-S9487Janoshik2025-Q197.914.39—Supplier-supplied1FAIL
AX-2025-020141GGPE-2410-S9487Janoshik2025-Q198.623.83—Supplier-supplied1FAIL
AX-2025-020142GGPE-2410-S9487Janoshik2025-Q197.933.82—Supplier-supplied1FAIL

Cross-sections

Other recent Enclomiphene citrate records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043146SSASSA-2603-C6950Medutest2026-Q297.923.1192.9Buyer-sourced2FAIL
AX-2026-042041TFCTFC-2605-H7009Nordanalyt2026-Q299.403.99103.7Supplier-supplied1FAIL
AX-2026-042042TFCTFC-2605-H7009Kestrel2026-Q299.324.7189.9Supplier-supplied2FAIL
AX-2026-043145SSASSA-2603-C6950VendorInvestigate2026-Q297.733.64—Buyer-sourced2FAIL
AX-2026-041604QSCQSC-2604-R7865Janoshik2026-Q299.934.22—Supplier-supplied0FAIL
AX-2026-042040TFCTFC-2605-H7009Janoshik2026-Q299.934.5797.2Supplier-supplied0FAIL
AX-2026-042043TFCTFC-2605-H7009PeptideMeter2026-Q299.213.98—Supplier-supplied1FAIL
AX-2026-042044TFCTFC-2605-H7009Janoshik2026-Q298.844.60—Supplier-supplied1FAIL
Other recent GGPeps records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042737SelankGGPE-2603-J9708Janoshik2026-Q398.409.1497.4Buyer-sourced0FAIL
AX-2026-042804SelankGGPE-2602-G2056Janoshik2026-Q398.507.97—Supplier-supplied0FAIL
AX-2026-042803SelankGGPE-2602-G2056Janoshik2026-Q398.488.01—Laboratory-retained1FAIL
AX-2026-042802SelankGGPE-2602-G2056Janoshik2026-Q398.747.0996.0Supplier-supplied0FAIL
AX-2026-042796SelankGGPE-2602-G2056Janoshik2026-Q398.267.5697.5Buyer-sourced0FAIL
AX-2026-042648Melanotan IIGGPE-2603-P8735Janoshik2026-Q399.106.97—Supplier-supplied4MARGINAL
AX-2026-042797SelankGGPE-2602-G2056Medutest2026-Q398.467.92—Buyer-sourced0FAIL
AX-2026-042669CJC-1295 (no DAC)GGPE-2606-E8495Medutest2026-Q398.614.0695.5Supplier-supplied0PASS