AX-2026-043397

Leuprolide · 5 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2604-K4076

FAILIDENTITY CONSISTENT

Report ID: AX-2026-043397
Compound: Leuprolide
Compound class: Hypothalamic and posterior-pituitary hormones
Supplier: WXT — WuXi TIDES (WuXi AppTec Testing Division)
Batch / lot: WXT-2604-K4076
Declared label claim: 5mg
Laboratory: Janoshik Analytical
Assay date: 16 Jul 2026
Submitted: 04 Aug 2026
Quarter: 2026-Q3
Submitter: Contributor #S-2298
Sample provenance: Buyer-sourced

Section 1

Results

Measured against the index acceptance specification for the hypothalamic and posterior-pituitary hormones 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	98.44	% area	≥ 98.5	FAIL
Total impurities	RP-HPLC, sum of reported peaks	1.56	% area	≤ 1.5	FAIL
Largest single impurity	RP-HPLC — ring-opened pGlu (+18 Da)	0.56	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	1208.6612	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	1208.6636	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+2.0	ppm	± 15	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	6.02	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.64	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.43	%	—	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	4.60	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	9.40	min	9.44 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.16	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	67,919	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [L-Leu6]-diastereomer	1.22	—	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 67,919, and skew follows the reported asymmetry factor of 1.16. 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 0.56 % impurity against a 98.44 % 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	Leuprolide — main peak	9.40	4,784,489	98.44	—
2	ring-opened pGlu (+18 Da)	8.94	27,218	0.56	+18.011
3	[L-Leu6]-diastereomer	9.22	21,871	0.45	0.000
4	oxidised Trp (+16 Da)	9.08	16,525	0.34	+15.995
5	des-ethylamide (+1 Da)	9.64	10,207	0.21	-27.047
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 1208.6612 Da, computed from C59H84N16O12. 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 1208.6636 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 (%)
3+	403.8943	403.8951	0.0008	8.8
2+	605.3379	605.3391	0.0012	55.3
1+	1209.6685	1209.6709	0.0024	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)	99.27	98.44	divergence +0.44 pp vs batch median
Total impurities (% area)	not stated	1.56
Largest single impurity (% area)	not stated	0.56
Water (%)	4.7	6.02
Counter-ion (%)	not stated	4.64
Peptide content (%w/w)	not stated	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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Domestic warehouse despatch → submitter (2–8 °C, 22 d) → laboratory (courier, cold pack, 3 d) → assay.
Assay date: 16 Jul 2026
Submitted to the index: 04 Aug 2026
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: IDENTITY CONSISTENT

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 WXT-2604-K4076 n=2

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043398	WXT-2604-K4076	Nordanalyt	2026-Q3	99.22	5.57	—	Supplier-supplied	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Leuprolide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043398	WXT	WXT-2604-K4076	Nordanalyt	2026-Q3	99.22	5.57	—	Supplier-supplied	0	PASS
AX-2026-043494	WXT	WXT-2511-S5991	Janoshik	2026-Q1	98.43	6.22	94.8	Supplier-supplied	1	FAIL
AX-2026-043493	WXT	WXT-2511-S5991	Janoshik	2026-Q1	98.31	5.24	—	Supplier-supplied	1	FAIL
AX-2026-042142	Homopeptide	HOMO-2508-N8842	Kestrel	2026-Q1	99.93	6.01	94.0	Supplier-supplied	2	MARGINAL
AX-2026-042143	Homopeptide	HOMO-2508-N8842	Kestrel	2026-Q1	99.82	5.08	93.7	Supplier-supplied	1	MARGINAL
AX-2026-042145	Homopeptide	HOMO-2508-N8842	Janoshik	2026-Q1	99.45	4.99	105.9	Laboratory-retained	2	MARGINAL
AX-2026-042146	Homopeptide	HOMO-2508-N8842	Medutest	2026-Q1	99.93	4.91	—	Supplier-supplied	1	MARGINAL
AX-2026-043497	WXT	WXT-2511-S5991	Janoshik	2026-Q1	97.86	5.69	—	Supplier-supplied	0	FAIL

Other recent WXT records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043488	Pramlintide	WXT-2603-D6052	Janoshik	2026-Q3	97.87	4.37	—	Supplier-supplied	1	MARGINAL
AX-2026-043406	Semaglutide	WXT-2604-C4728	Janoshik	2026-Q3	97.24	4.65	—	Supplier-supplied	1	MARGINAL
AX-2026-043421	Sermorelin	WXT-2608-P4867	Janoshik	2026-Q3	98.15	3.09	—	Supplier-supplied	0	PASS
AX-2026-043420	Sermorelin	WXT-2608-P4867	Medutest	2026-Q3	98.62	3.07	96.4	Supplier-supplied	0	PASS
AX-2026-043423	Sermorelin	WXT-2608-P4867	Janoshik	2026-Q3	98.28	3.86	98.5	Buyer-sourced	0	PASS
AX-2026-043401	Semaglutide	WXT-2604-C4728	Medutest	2026-Q3	97.70	4.78	91.5	Supplier-supplied	1	MARGINAL
AX-2026-043400	Semaglutide	WXT-2604-C4728	Nordanalyt	2026-Q3	96.86	4.11	106.4	Laboratory-retained	1	FAIL
AX-2026-043422	Sermorelin	WXT-2608-P4867	Medutest	2026-Q3	98.35	3.59	—	Supplier-supplied	1	MARGINAL