AX-2025-020278

Enclomiphene citrate · 25 mg declared · Xi'an Mokemei Biotechnology Co., Ltd. · lot MKM-2408-L2880

FAILPURITY ONLY

Report ID: AX-2025-020278
Compound: Enclomiphene citrate
Compound class: Non-peptide adjuncts
Supplier: MKM — Xi'an Mokemei Biotechnology Co., Ltd.
Batch / lot: MKM-2408-L2880
Declared label claim: 25mg
Laboratory: Janoshik Analytical
Assay date: 18 Feb 2025
Submitted: 26 Feb 2025
Quarter: 2025-Q1
Submitter: er.adeyemi
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	97.97	% area	≥ 98.5	FAIL
Total impurities	RP-HPLC, sum of reported peaks	2.03	% area	≤ 1.5	FAIL
Largest single impurity	RP-HPLC — free base (des-citrate)	1.44	% area	≤ 1.00	FAIL
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	66.19	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	64.85	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	37.81	mg	25 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	24.520	mg	25 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	98.1	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.91	%	≤ 10.0	PASS
Counter-ion (citrate)	anion-exchange ion chromatography	29.09	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.81	%	—	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 after 90 s gentle swirling, no particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.44	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	16.42	min	16.44 ± 0.35 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.10	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	71,730	—	≥ 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 71,730, and skew follows the reported asymmetry factor of 1.10. 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 1.44 % impurity against a 97.97 % 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	16.42	4,761,646	97.97	—
2	free base (des-citrate)	16.44	69,988	1.44	-192.027
3	des-ethyl enclomiphene (−28 Da)	15.98	18,955	0.39	-28.031
4	zuclomiphene (cis-isomer)	15.80	6,318	0.13	0.000
5	N-oxide (+16 Da)	15.54	3,402	0.07	+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	3.91
Counter-ion (citrate)	ion chromatography	29.09
Residual solvent + inorganic residue	estimated	0.81
Total peptide content	by difference	66.19
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)	98.20	97.97	divergence +0.17 pp vs batch median
Total impurities (% area)	1.80	2.03
Largest single impurity (% area)	0.77	1.44
Water (%)	3.7	3.91
Counter-ion (%)	not stated	29.09
Peptide content (%w/w)	not stated	66.19
Endotoxin (EU/mg)	0.43	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, 8 d) → assay. Submitter did not handle the vial.
Assay date: 18 Feb 2025
Submitted to the index: 26 Feb 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: PURITY ONLY

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

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 MKM-2408-L2880 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020276	MKM-2408-L2880	Nordanalyt	2025-Q1	97.85	4.03	89.6	Buyer-sourced	2	FAIL
AX-2025-020277	MKM-2408-L2880	Janoshik	2025-Q1	98.11	4.19	89.2	Supplier-supplied	2	FAIL
AX-2025-020279	MKM-2408-L2880	Janoshik	2025-Q1	98.26	4.26	—	Supplier-supplied	1	FAIL
AX-2025-020280	MKM-2408-L2880	Janoshik	2025-Q1	98.02	4.51	90.1	Supplier-supplied	1	FAIL
AX-2025-020281	MKM-2408-L2880	Janoshik	2025-Q1	98.12	4.20	103.7	Supplier-supplied	1	FAIL
AX-2025-020282	MKM-2408-L2880	Janoshik	2025-Q1	98.03	4.35	107.4	Buyer-sourced	1	FAIL
AX-2025-020283	MKM-2408-L2880	VendorInvestigate	2025-Q1	97.48	4.27	88.9	Buyer-sourced	2	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 MKM records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042943	Adipotide	MKM-2606-K4013	Janoshik	2026-Q3	97.92	6.31	—	Supplier-supplied	1	MARGINAL
AX-2026-042891	CJC-1295 (no DAC)	MKM-2603-V2347	Janoshik	2026-Q3	99.28	3.63	—	Supplier-supplied	1	MARGINAL
AX-2026-042942	Adipotide	MKM-2606-K4013	VendorInvestigate	2026-Q3	97.04	5.56	94.6	Buyer-sourced	1	FAIL
AX-2026-042914	Gonadorelin	MKM-2604-A2596	Janoshik	2026-Q2	99.93	5.19	—	Supplier-supplied	0	PASS
AX-2026-042884	BPC-157	MKM-2605-X2575	Nordanalyt	2026-Q2	98.12	2.89	—	Laboratory-retained	1	MARGINAL
AX-2026-042946	Tirzepatide	MKM-2601-L3752	Medutest	2026-Q2	97.71	8.10	—	Supplier-supplied	1	FAIL
AX-2026-042911	Gonadorelin	MKM-2604-A2596	Medutest	2026-Q2	99.08	5.55	—	Buyer-sourced	1	MARGINAL
AX-2026-042932	L-Glutathione (reduced)	MKM-2511-F2902	Janoshik	2026-Q2	98.57	8.41	92.9	Supplier-supplied	1	MARGINAL