AX-2026-043164 · Enclomiphene citrate · SSA lot SSA-2603-C7061

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	98.48	% area	≥ 98.5	FAIL
Total impurities	RP-HPLC, sum of reported peaks	1.52	% area	≤ 1.5	FAIL
Largest single impurity	RP-HPLC — N-oxide (+16 Da)	0.67	% 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)	597.2068	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-10.4	ppm	± 10	FAIL
Total peptide content	by difference from the gravimetric mass balance	63.29	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	62.33	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	86.15	mg	50 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	53.697	mg	50 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	107.4	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.27	%	≤ 10.0	PASS
Counter-ion (citrate)	anion-exchange ion chromatography	32.53	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.91	%	—	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	Clear, colourless, no visible particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	6.10	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	9.02	min	8.88 ± 0.35 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.04	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	62,466	—	≥ 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 62,466, and skew follows the reported asymmetry factor of 1.04. 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 0.67 % impurity against a 98.48 % 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	9.02	4,786,433	98.48	—
2	N-oxide (+16 Da)	8.58	32,564	0.67	+15.995
3	free base (des-citrate)	9.03	17,983	0.37	-192.027
4	zuclomiphene (cis-isomer)	8.71	12,151	0.25	0.000
5	des-ethyl enclomiphene (−28 Da)	8.80	11,179	0.23	-28.031
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 597.2068 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	598.2141	-0.0062	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	3.27
Counter-ion (citrate)	ion chromatography	32.53
Residual solvent + inorganic residue	estimated	0.91
Total peptide content	by difference	63.29
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)	98.66	98.48	divergence +0.18 pp vs batch median
Total impurities (% area)	0.72	1.52
Largest single impurity (% area)	not stated	0.67
Water (%)	not stated	3.27
Counter-ion (%)	2.7	32.53
Peptide content (%w/w)	93.2	63.29
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: Retail purchase → submitter (ambient, 1 d) → laboratory (courier, cold pack, 2 d) → assay.
Assay date: 11 Apr 2026
Submitted to the index: 19 Apr 2026
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 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.

low_n19 Apr 2026

n=1 on this lot. A single result below specification is a finding about a vial. Two agreeing results would make it a finding about a lot, and the batch page will say which of those exists.

peak_integrator19 Apr 2026

Reporting threshold matters at this level. Peaks below threshold are excluded from the impurity total but included in the purity denominator, which biases 98.48 % upward by a systematic tenth or so. The gap here is larger than that.

ms_confirm19 Apr 2026

The purity, water and counter-ion figures on this record stand regardless of the mass question. Only the identity limb is affected, and the status field says exactly that.

storage_stated19 Apr 2026

The index cannot verify that the vial assayed is representative of the lot it came from, and says so on every record. Provenance narrows that gap; it does not close it.

Section 7

Related records

Same batch — lot SSA-2603-C7061 n=1

This is the only report on this lot. One report is not a batch characterisation.

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-2026-041773	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
AX-2025-020316	GGPeps	GGPE-2510-H2976	Nordanalyt	2025-Q4	99.93	5.38	—	Laboratory-retained	0	FAIL

Other recent SSA records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043135	BPC-157	SSA-2601-N6863	Nordanalyt	2026-Q2	98.16	4.66	92.8	Buyer-sourced	1	MARGINAL
AX-2026-043160	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.01	4.02	91.8	Buyer-sourced	0	PASS
AX-2026-043157	GHK-Cu	SSA-2604-V7731	Medutest	2026-Q2	99.19	5.14	—	Supplier-supplied	0	PASS
AX-2026-043141	BPC-157	SSA-2601-N6863	Janoshik	2026-Q2	98.06	4.06	94.6	Buyer-sourced	1	MARGINAL
AX-2026-043154	GHK-Cu	SSA-2604-V7731	PeptideMeter	2026-Q2	97.82	4.82	101.6	Buyer-sourced	0	PASS
AX-2026-043137	BPC-157	SSA-2601-N6863	PeptideMeter	2026-Q2	98.17	4.14	—	Buyer-sourced	1	MARGINAL
AX-2026-043162	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.50	4.36	—	Supplier-supplied	0	PASS
AX-2026-043134	BPC-157	SSA-2601-N6863	Medutest	2026-Q2	97.89	4.01	—	Buyer-sourced	1	FAIL