AX-2025-021201 · Enclomiphene citrate · PPG lot PPG-2509-M6879

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, 30 min gradient, 214 nm	99.56	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.44	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — zuclomiphene (cis-isomer)	0.25	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	61.82	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	61.55	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	38.96	mg	25 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	23.980	mg	25 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	95.9	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	6.82	%	≤ 10.0	PASS
Counter-ion (citrate)	anion-exchange ion chromatography	30.68	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.68	%	—	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 cake, partial shrinkage from vial wall	—	white to off-white intact cake	FAIL
Reconstitution clarity	reconstituted per submitter procedure	Clear after 90 s gentle swirling, no particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.00	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	16.52	min	16.44 ± 0.35 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.99	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	75,174	—	≥ 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, 30 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 75,174, and skew follows the reported asymmetry factor of 0.99. 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 0.25 % impurity against a 99.56 % 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	16.52	4,838,925	99.56	—
2	zuclomiphene (cis-isomer)	15.90	12,151	0.25	0.000
3	free base (des-citrate)	16.54	5,346	0.11	-192.027
4	des-ethyl enclomiphene (−28 Da)	16.08	2,430	0.05	-28.031
5	N-oxide (+16 Da)	15.64	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 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	6.82
Counter-ion (citrate)	ion chromatography	30.68
Residual solvent + inorganic residue	estimated	0.68
Total peptide content	by difference	61.82
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)	99.33	99.56	divergence -0.23 pp vs batch median
Total impurities (% area)	0.67	0.44
Largest single impurity (% area)	not stated	0.25
Water (%)	5.4	6.82
Counter-ion (%)	4.1	30.68
Peptide content (%w/w)	89.9	61.82
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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Retail purchase → submitter (ambient, 21 d) → laboratory (hand-carried, 4 d) → assay.
Assay date: 06 Oct 2025
Submitted to the index: 16 Oct 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: PARTIAL

What this report does not establish

That the compound is the compound named. No identity confirmation was ordered on this submission. A purity figure describes chromatographic homogeneity of whatever eluted; it does not name it.
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 3

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.

sig_figs16 Oct 2025

Two decimal places on 99.56 % implies repeatability better than 0.01 pp, which no laboratory here claims. The number is sound; the printed precision is more than the method carries.

Index data team

Two decimal places are retained because the source reports carry them and truncating would discard information where a laboratory genuinely reports it. The uncertainty budget on /methods/uncertainty-budget/ is the right thing to read alongside any purity figure on this site.

storage_stated16 Oct 2025

Stated storage conditions on the certificate against the observed transit conditions in the custody block: on this record they agree, which removes one class of explanation for anything unexpected.

uncertainty_budget16 Oct 2025

Integration boundary on a close pair contributes up to 0.45 pp of standard uncertainty on its own. That is the term to quote alongside 99.56 % rather than a resolution verdict.

Section 7

Related records

Same batch — lot PPG-2509-M6879 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-2026-043164	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 PPG records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043598	Tesamorelin	PPG-2608-A6835	Kestrel	2026-Q3	98.91	2.56	100.3	Buyer-sourced	1	FAIL
AX-2026-043597	Tesamorelin	PPG-2608-A6835	Janoshik	2026-Q3	98.54	1.15	—	Buyer-sourced	0	PASS
AX-2026-043596	Tesamorelin	PPG-2608-A6835	PeptideMeter	2026-Q3	98.74	1.83	105.1	Buyer-sourced	1	MARGINAL
AX-2026-043605	Retatrutide	PPG-2604-X7060	Janoshik	2026-Q2	98.17	4.29	99.7	Buyer-sourced	0	PASS
AX-2026-043601	Retatrutide	PPG-2604-X7060	Janoshik	2026-Q2	98.28	3.96	95.3	Buyer-sourced	0	PASS
AX-2026-043668	AOD-9604	PPG-2602-W8018	PeptideMeter	2026-Q2	99.47	3.06	—	Buyer-sourced	0	PASS
AX-2026-043670	AOD-9604	PPG-2602-W8018	PeptideMeter	2026-Q2	99.56	2.71	104.5	Buyer-sourced	0	PASS
AX-2026-043630	CJC-1295 (no DAC)	PPG-2512-D7211	Janoshik	2026-Q2	99.66	5.11	92.5	Buyer-sourced	0	PASS