AX-2024-004608

Enclomiphene citrate · 50 mg declared · Tianjin Finder Chemical Co., Ltd. · lot TFC-2404-J4890

FAILPARTIAL

Report ID: AX-2024-004608
Compound: Enclomiphene citrate
Compound class: Non-peptide adjuncts
Supplier: TFC — Tianjin Finder Chemical Co., Ltd.
Batch / lot: TFC-2404-J4890
Declared label claim: 50mg
Laboratory: Janoshik Analytical
Assay date: 25 Jul 2024
Submitted: 06 Aug 2024
Quarter: 2024-Q3
Submitter: ha.frisk
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.

Parameter	Method	Result	Unit	Index spec
Purity	RP-HPLC, 30 min gradient, 214 nm	99.58	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.42	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — zuclomiphene (cis-isomer)	0.17	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	597.2130	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	597.2146	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+2.7	ppm	± 10	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	4.18	%	≤ 10.0	PASS
Counter-ion (citrate)	anion-exchange ion chromatography	31.97	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.74	%	—	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	Off-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	5.75	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	16.47	min	16.44 ± 0.35 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.98	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	52,922	—	≥ 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, 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 52,922, and skew follows the reported asymmetry factor of 0.98. 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 0.17 % impurity against a 99.58 % 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	16.47	4,839,897	99.58	—
2	zuclomiphene (cis-isomer)	15.85	8,263	0.17	0.000
3	N-oxide (+16 Da)	15.59	6,318	0.13	+15.995
4	des-ethyl enclomiphene (−28 Da)	16.03	3,402	0.07	-28.031
5	free base (des-citrate)	16.49	2,430	0.05	-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, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 597.2146 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	598.2219	0.0016	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.

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)	99.81	99.58	divergence +0.23 pp vs batch median
Total impurities (% area)	not stated	0.42
Largest single impurity (% area)	not stated	0.17
Water (%)	not stated	4.18
Counter-ion (%)	not stated	31.97
Peptide content (%w/w)	91.7	not determined
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 6 d) → assay. Submitter did not handle the vial.
Assay date: 25 Jul 2024
Submitted to the index: 06 Aug 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: PARTIAL

What this report does not establish

How much of the named compound is in the vial. Peptide content was not determined, so recovered mass cannot be calculated and the label claim cannot be checked.
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

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 TFC-2404-J4890 n=3

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004609	TFC-2404-J4890	Janoshik	2024-Q3	99.18	4.34	—	Supplier-supplied	1	FAIL
AX-2024-004610	TFC-2404-J4890	PeptideMeter	2024-Q3	99.93	3.88	94.6	Supplier-supplied	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-2026-043146	SSA	SSA-2603-C6950	Medutest	2026-Q2	97.92	3.11	92.9	Buyer-sourced	2	FAIL
AX-2026-042041	TFC	TFC-2605-H7009	Nordanalyt	2026-Q2	99.40	3.99	103.7	Supplier-supplied	1	FAIL
AX-2026-042042	TFC	TFC-2605-H7009	Kestrel	2026-Q2	99.32	4.71	89.9	Supplier-supplied	2	FAIL
AX-2026-043145	SSA	SSA-2603-C6950	VendorInvestigate	2026-Q2	97.73	3.64	—	Buyer-sourced	2	FAIL
AX-2026-041604	QSC	QSC-2604-R7865	Janoshik	2026-Q2	99.93	4.22	—	Supplier-supplied	0	FAIL
AX-2026-042040	TFC	TFC-2605-H7009	Janoshik	2026-Q2	99.93	4.57	97.2	Supplier-supplied	0	FAIL
AX-2026-042043	TFC	TFC-2605-H7009	PeptideMeter	2026-Q2	99.21	3.98	—	Supplier-supplied	1	FAIL
AX-2026-042044	TFC	TFC-2605-H7009	Janoshik	2026-Q2	98.84	4.60	—	Supplier-supplied	1	FAIL

Other recent TFC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041932	Semaglutide	TFC-2604-X4301	Janoshik	2026-Q3	98.88	4.31	—	Supplier-supplied	0	PASS
AX-2026-042067	SS-31 (Elamipretide)	TFC-2604-Y7472	Kestrel	2026-Q3	98.66	4.44	—	Supplier-supplied	1	MARGINAL
AX-2026-042057	Sermorelin	TFC-2605-Y6440	Janoshik	2026-Q3	98.68	3.94	98.3	Supplier-supplied	0	PASS
AX-2026-041936	Semaglutide	TFC-2604-X4301	PeptideMeter	2026-Q3	98.62	4.30	—	Buyer-sourced	1	MARGINAL
AX-2026-041973	Humanin (HNG)	TFC-2605-U5564	Janoshik	2026-Q3	99.62	7.03	—	Supplier-supplied	2	FAIL
AX-2026-041980	Humanin (HNG)	TFC-2605-U5564	Janoshik	2026-Q3	99.90	7.01	88.6	Supplier-supplied	2	MARGINAL
AX-2026-041961	Tirzepatide	TFC-2605-G5134	Medutest	2026-Q3	98.25	7.11	—	Supplier-supplied	2	MARGINAL
AX-2026-042068	SS-31 (Elamipretide)	TFC-2604-Y7472	Medutest	2026-Q3	98.71	3.63	92.9	Supplier-supplied	2	MARGINAL