AX-2025-020894 · Enclomiphene citrate · WXT lot WXT-2506-V2798

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.

Parameter	Method	Result	Unit	Index spec
Purity	RP-HPLC, 15 min gradient, 214 nm	99.34	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.66	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — zuclomiphene (cis-isomer)	0.37	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	597.2130	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	597.2098	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-5.3	ppm	± 10	PASS
Total peptide content	by difference from the gravimetric mass balance	67.67	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	67.22	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	68.71	mg	50 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	46.187	mg	50 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	92.4	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.33	%	≤ 10.0	PASS
Counter-ion (citrate)	anion-exchange ion chromatography	27.68	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.32	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
Sterility	membrane filtration, USP <71>, 14 d	No growth at 14 d	—	no growth	PASS
Appearance	visual, diffuse light, black and white background	White lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Clear, colourless, no visible particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	3.99	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	8.91	min	8.88 ± 0.35 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.14	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	62,123	—	≥ 20,000	PASS
Resolution to nearest impurity	vs free base (des-citrate)	0.07	—	no index criterion	REPORTED

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.

Figure 1. RP-HPLC trace, 15 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 62,123, and skew follows the reported asymmetry factor of 1.14. 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 0.37 % impurity against a 99.34 % main peak is a line two pixels tall; the main peak runs off-scale there by design.

#	Peak	RT	Area (µV·s)	% area	Δ mass (Da)
1	Enclomiphene citrate — main peak	8.91	4,828,232	99.34	—
2	zuclomiphene (cis-isomer)	8.60	17,983	0.37	0.000
3	des-ethyl enclomiphene (−28 Da)	8.69	6,318	0.13	-28.031
4	N-oxide (+16 Da)	8.47	3,888	0.08	+15.995
5	free base (des-citrate)	8.92	3,888	0.08	-192.027
Closure check — purity + Σ impurities				100.00	CLOSES

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.

Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 597.2098 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.

Charge	Theoretical m/z	Observed m/z	Δ m/z	Rel. abundance (%)
1+	598.2203	598.2171	-0.0032	100.0

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.

Component	Determination	%w/w of cake
Water	Karl Fischer	4.33
Counter-ion (citrate)	ion chromatography	27.68
Residual solvent + inorganic residue	estimated	0.32
Total peptide content	by difference	67.67
Total		100.00 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.

Figure	Supplier COA	This report	Index note
Purity (% area)	98.82	99.34	divergence -0.26 pp vs batch median
Total impurities (% area)	1.18	0.66
Largest single impurity (% area)	0.76	0.37
Water (%)	4.0	4.33
Counter-ion (%)	not stated	27.68
Peptide content (%w/w)	91.2	67.67
Endotoxin (EU/mg)	not stated	not determined
Method stated on certificate	YES	—	column, gradient and wavelength given

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, 12 d) → assay. Submitter did not handle the vial.
Assay date: 01 Aug 2025
Submitted to the index: 25 Aug 2025
Laboratory: Kestrel Bioanalytical, Melbourne, Australia
Method basis: 15 min gradient · unit-resolution MS
Verification status: PARTIAL

What this report does not establish

That the compound is not a near-isobaric alternative. Identity was confirmed at unit mass resolution, which cannot exclude species differing by 1 or 2 Da. The specific alternatives not excluded are named in the identity block above.
That the material is free of bacterial endotoxin. Endotoxin was not measured. No chromatographic result bears on it.
That any other vial in the same lot has the same composition. One vial was tested. Within-lot vial-to-vial variation in this index has a median of 0.28 pp and a 90th percentile of 0.74 pp.
That any other lot from the same supplier has the same composition. Batch-to-batch variation is larger than within-batch variation for every supplier here.
That the material is suitable for administration to a human or an animal. These are research compounds. No result on this site is a safety assessment and the index takes no position on use.
That the material was manufactured by the supplier that sold it. Contract synthesis is normal in this market and twenty-nine batches in the index fingerprint to a bulk from a different company than the one named on the label.

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.

c18_2p625 Aug 2025

Column chemistry flatters or punishes a figure like this. A core-shell column at this gradient resolves the close-eluting family that a fully porous 5 µm bed merges, so 99.34 % here is a harder number than the same figure from a coarser column.

coa_template25 Aug 2025

The certificate for WXT-2506-V2798 carries a named related-substances table rather than a totals line. That is what makes 99.34 % checkable against this record instead of merely comparable to it.

mass_defect25 Aug 2025

Every named impurity on this record has a mass defect consistent with its structural assignment. That is the check that distinguishes an assignment from a guess.

lot_traceability25 Aug 2025

Lot WXT-2506-V2798 on this sample can be checked against retail stock by anyone who buys one. That is a concrete, cheap piece of work and it would resolve the provenance question for this lot outright.

Section 7

Related records

Same batch — lot WXT-2506-V2798 n=5

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020892	WXT-2506-V2798	VendorInvestigate	2025-Q3	98.91	4.29	—	Buyer-sourced	0	FAIL
AX-2025-020893	WXT-2506-V2798	Janoshik	2025-Q3	98.91	4.31	—	Buyer-sourced	0	FAIL
AX-2025-020895	WXT-2506-V2798	VendorInvestigate	2025-Q3	99.21	4.50	106.2	Buyer-sourced	1	FAIL
AX-2025-020896	WXT-2506-V2798	Janoshik	2025-Q3	99.08	4.96	95.7	Buyer-sourced	0	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Enclomiphene citrate records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041525	QSC	QSC-2604-R6644	PeptideMeter	2026-Q2	99.80	4.04	101.5	Laboratory-retained	0	FAIL
AX-2026-042329	TFC	TFC-2605-H2745	Nordanalyt	2026-Q2	99.41	3.67	—	Buyer-sourced	2	FAIL
AX-2026-041524	QSC	QSC-2604-R6644	PeptideMeter	2026-Q2	99.93	4.60	91.6	Buyer-sourced	0	FAIL
AX-2026-041526	QSC	QSC-2604-R6644	Medutest	2026-Q2	99.68	4.25	103.7	Buyer-sourced	1	FAIL
AX-2026-043164	SSA	SSA-2603-C7061	Kestrel	2026-Q2	98.48	3.27	107.4	Buyer-sourced	2	FAIL
AX-2026-041773	ASY	ASY-{CAT}-1806	Janoshik	2025-Q4	99.88	3.59	—	Buyer-sourced	1	FAIL
AX-2025-019360	HYB	HYB-2510-J6404	Medutest	2025-Q4	99.61	5.07	98.1	Laboratory-retained	0	FAIL
AX-2025-018986	ASY	ASY-{CAT}-1806	Medutest	2025-Q4	99.93	3.35	—	Buyer-sourced	1	FAIL

Other recent WXT records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043376	Semaglutide	WXT-2604-C3248	Janoshik	2026-Q3	97.08	4.22	—	Buyer-sourced	1	MARGINAL
AX-2026-043429	L-Glutathione (reduced)	WXT-2605-B3833	Nordanalyt	2026-Q3	98.48	6.58	96.9	Supplier-supplied	1	FAIL
AX-2026-043347	Leuprolide	WXT-2604-K2596	PeptideMeter	2026-Q3	99.16	5.99	93.6	Buyer-sourced	0	PASS
AX-2026-043353	Leuprolide	WXT-2604-K2596	Janoshik	2026-Q3	99.19	4.90	95.3	Laboratory-retained	0	PASS
AX-2026-043345	Leuprolide	WXT-2604-K2596	Janoshik	2026-Q3	98.93	5.28	—	Buyer-sourced	0	PASS
AX-2026-043424	L-Glutathione (reduced)	WXT-2605-B3833	PeptideMeter	2026-Q3	98.37	6.86	—	Buyer-sourced	0	FAIL
AX-2026-043374	Semaglutide	WXT-2604-C3248	Janoshik	2026-Q3	97.00	3.56	—	Buyer-sourced	1	MARGINAL
AX-2026-043377	Semaglutide	WXT-2604-C3248	PeptideMeter	2026-Q3	97.20	4.08	—	Buyer-sourced	1	MARGINAL