AX-2025-018657 · Enclomiphene citrate · QSC lot QSC-2501-L5841

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, 25 min gradient, 214 nm	99.64	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.36	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — zuclomiphene (cis-isomer)	0.24	% 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)	597.2130	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	0.0	ppm	± 10	PASS
Total peptide content	by difference from the gravimetric mass balance	67.36	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	67.12	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	17.38	mg	12.5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	11.665	mg	12.5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	93.3	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.66	%	≤ 10.0	PASS
Counter-ion (citrate)	anion-exchange ion chromatography	26.54	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.44	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
Sterility	not ordered on this submission	not determined	—	no growth	NOT TESTED
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	Visible particulates, did not clear	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.13	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	13.79	min	13.92 ± 0.35 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.09	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	78,101	—	≥ 20,000	PASS
Resolution to nearest impurity	vs free base (des-citrate)	0.08	—	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, 25 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 78,101, and skew follows the reported asymmetry factor of 1.09. 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 0.24 % impurity against a 99.64 % 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	13.79	4,842,813	99.64	—
2	zuclomiphene (cis-isomer)	13.27	11,665	0.24	0.000
3	des-ethyl enclomiphene (−28 Da)	13.42	2,430	0.05	-28.031
4	free base (des-citrate)	13.81	1,944	0.04	-192.027
5	N-oxide (+16 Da)	13.06	1,458	0.03	+15.995
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 597.2130 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	598.2203	0.0000	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	5.66
Counter-ion (citrate)	ion chromatography	26.54
Residual solvent + inorganic residue	estimated	0.44
Total peptide content	by difference	67.36
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)	99.67	99.64	divergence -0.11 pp vs batch median
Total impurities (% area)	0.33	0.36
Largest single impurity (% area)	0.14	0.24
Water (%)	not stated	5.66
Counter-ion (%)	4.5	26.54
Peptide content (%w/w)	91.4	67.36
Endotoxin (EU/mg)	not stated	not determined
Method stated on certificate	NO	—	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, 31 d) → laboratory (courier, cold pack, 7 d) → assay.
Assay date: 18 Apr 2025
Submitted to the index: 22 Apr 2025
Laboratory: Medutest, Ljubljana, Slovenia
Method basis: 25 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 the material is sterile. Sterility was not tested.
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.

buyer_sourced22 Apr 2025

Ordering under an unremarkable name and address is the whole method. It requires no cooperation from anybody and it produces the strongest evidence this index holds.

coa_reader22 Apr 2025

The certificate that arrives with a retail order is the certificate an ordinary buyer gets. Assessing it is assessing the real documentation practice rather than the sample-request one.

sole_source22 Apr 2025

On compounds with a single supplier, independently purchased records are the only thing preventing the evidence base from being entirely supplier-generated. They matter disproportionately there.

acetate_only22 Apr 2025

The index's mass balance on this record closes to two decimal places with 26.54 % citrate in it. The number is not an anomaly; it is a component of a coherent gravimetric picture.

Section 7

Related records

Same batch — lot QSC-2501-L5841 n=3

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-018658	QSC-2501-L5841	Kestrel	2025-Q2	99.93	6.59	94.1	Buyer-sourced	0	FAIL
AX-2025-018659	QSC-2501-L5841	Janoshik	2025-Q2	99.78	5.88	—	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 QSC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041599	CJC-1295 (no DAC)	QSC-2606-V7416	VendorInvestigate	2026-Q3	97.96	3.52	—	Buyer-sourced	1	FAIL
AX-2026-041601	CJC-1295 (no DAC)	QSC-2606-V7416	Kestrel	2026-Q3	98.33	4.10	—	Buyer-sourced	1	MARGINAL
AX-2026-041602	CJC-1295 (no DAC)	QSC-2606-V7416	VendorInvestigate	2026-Q3	98.36	3.38	101.8	Buyer-sourced	1	MARGINAL
AX-2026-041477	Triptorelin	QSC-2607-C5749	Nordanalyt	2026-Q3	99.53	3.42	—	Buyer-sourced	0	PASS
AX-2026-041600	CJC-1295 (no DAC)	QSC-2606-V7416	Nordanalyt	2026-Q3	97.74	4.91	100.9	Buyer-sourced	1	FAIL
AX-2026-041603	CJC-1295 (no DAC)	QSC-2606-V7416	PeptideMeter	2026-Q3	98.43	4.20	—	Buyer-sourced	1	MARGINAL
AX-2026-041606	CJC-1295 (no DAC)	QSC-2606-V7416	Janoshik	2026-Q3	98.03	3.58	—	Buyer-sourced	1	MARGINAL
AX-2026-041585	Liraglutide	QSC-2605-W7381	Medutest	2026-Q3	99.59	5.09	92.8	Laboratory-retained	0	PASS