AX-2026-043349 · Leuprolide · WXT lot WXT-2604-K2596

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, 32 min gradient, 214 nm	98.64	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.36	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — oxidised Trp (+16 Da)	0.90	% 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)	1208.6610	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-0.2	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	90.13	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.90	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.91	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	5.254	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	105.1	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.23	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.14	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.50	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.29	EU/mg	≤ 5.0	PASS
Sterility	not ordered on this submission	not determined	—	no growth	NOT TESTED
Appearance	visual, diffuse light, black and white background	White cake, partially collapsed	—	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	5.11	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 32 min gradient	9.95	min	10.02 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.12	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	55,232	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [L-Leu6]-diastereomer	1.11	—	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, 32 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 55,232, and skew follows the reported asymmetry factor of 1.12. 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 0.90 % impurity against a 98.64 % 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	9.95	4,794,210	98.64	—
2	oxidised Trp (+16 Da)	9.61	43,743	0.90	+15.995
3	[L-Leu6]-diastereomer	9.76	12,637	0.26	0.000
4	des-ethylamide (+1 Da)	10.21	6,318	0.13	-27.047
5	ring-opened pGlu (+18 Da)	9.46	3,402	0.07	+18.011
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 1208.6610 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	403.8943	-0.0000	8.8
2+	605.3379	605.3378	-0.0001	52.6
1+	1209.6685	1209.6683	-0.0002	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	5.23
Counter-ion (acetate)	ion chromatography	4.14
Residual solvent + inorganic residue	estimated	0.50
Total peptide content	by difference	90.13
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)	98.88	98.64	divergence +0.05 pp vs batch median
Total impurities (% area)	1.12	1.36
Largest single impurity (% area)	0.63	0.90
Water (%)	not stated	5.23
Counter-ion (%)	not stated	4.14
Peptide content (%w/w)	not stated	90.13
Endotoxin (EU/mg)	0.35	0.29
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 (−20 °C, 29 d) → laboratory (courier, dry ice, 8 d) → assay.
Assay date: 13 Jul 2026
Submitted to the index: 23 Jul 2026
Laboratory: VendorInvestigate, Riga, Latvia
Method basis: 32 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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-K2596 n=12

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-043344	WXT-2604-K2596	Janoshik	2026-Q3	98.58	5.34	—	Buyer-sourced	PASS
AX-2026-043345	WXT-2604-K2596	Janoshik	2026-Q3	98.93	5.28	—	Buyer-sourced	PASS
AX-2026-043346	WXT-2604-K2596	PeptideMeter	2026-Q3	98.63	5.85	94.7	Laboratory-retained	PASS
AX-2026-043347	WXT-2604-K2596	PeptideMeter	2026-Q3	99.16	5.99	93.6	Buyer-sourced	PASS
AX-2026-043348	WXT-2604-K2596	Janoshik	2026-Q3	98.70	5.74	99.0	Buyer-sourced	PASS
AX-2026-043350	WXT-2604-K2596	Medutest	2026-Q3	99.01	5.65	101.3	Buyer-sourced	PASS
AX-2026-043351	WXT-2604-K2596	Kestrel	2026-Q3	98.48	5.32	—	Buyer-sourced	FAIL
AX-2026-043352	WXT-2604-K2596	Janoshik	2026-Q3	99.11	5.51	—	Buyer-sourced	PASS
AX-2026-043353	WXT-2604-K2596	Janoshik	2026-Q3	99.19	4.90	95.3	Laboratory-retained	PASS
AX-2026-043354	WXT-2604-K2596	Janoshik	2026-Q3	99.41	5.44	—	Supplier-supplied	PASS
AX-2026-043355	WXT-2604-K2596	VendorInvestigate	2026-Q3	98.73	5.94	—	Buyer-sourced	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Leuprolide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-043347	WXT	WXT-2604-K2596	PeptideMeter	2026-Q3	99.16	5.99	93.6	Buyer-sourced	PASS
AX-2026-043353	WXT	WXT-2604-K2596	Janoshik	2026-Q3	99.19	4.90	95.3	Laboratory-retained	PASS
AX-2026-043345	WXT	WXT-2604-K2596	Janoshik	2026-Q3	98.93	5.28	—	Buyer-sourced	PASS
AX-2026-043346	WXT	WXT-2604-K2596	PeptideMeter	2026-Q3	98.63	5.85	94.7	Laboratory-retained	PASS
AX-2026-043348	WXT	WXT-2604-K2596	Janoshik	2026-Q3	98.70	5.74	99.0	Buyer-sourced	PASS
AX-2026-043354	WXT	WXT-2604-K2596	Janoshik	2026-Q3	99.41	5.44	—	Supplier-supplied	PASS
AX-2026-043355	WXT	WXT-2604-K2596	VendorInvestigate	2026-Q3	98.73	5.94	—	Buyer-sourced	PASS
AX-2026-043352	WXT	WXT-2604-K2596	Janoshik	2026-Q3	99.11	5.51	—	Buyer-sourced	PASS

Other recent WXT records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043376	Semaglutide	WXT-2604-C3248	Janoshik	2026-Q3	97.08	4.22	—	Buyer-sourced	1	MARGINAL
AX-2026-043429	L-Glutathione (reduced)	WXT-2605-B3833	Nordanalyt	2026-Q3	98.48	6.58	96.9	Supplier-supplied	1	FAIL
AX-2026-043347	Leuprolide	WXT-2604-K2596	PeptideMeter	2026-Q3	99.16	5.99	93.6	Buyer-sourced	0	PASS
AX-2026-043353	Leuprolide	WXT-2604-K2596	Janoshik	2026-Q3	99.19	4.90	95.3	Laboratory-retained	0	PASS
AX-2026-043345	Leuprolide	WXT-2604-K2596	Janoshik	2026-Q3	98.93	5.28	—	Buyer-sourced	0	PASS
AX-2026-043424	L-Glutathione (reduced)	WXT-2605-B3833	PeptideMeter	2026-Q3	98.37	6.86	—	Buyer-sourced	0	FAIL
AX-2026-043374	Semaglutide	WXT-2604-C3248	Janoshik	2026-Q3	97.00	3.56	—	Buyer-sourced	1	MARGINAL
AX-2026-043377	Semaglutide	WXT-2604-C3248	PeptideMeter	2026-Q3	97.20	4.08	—	Buyer-sourced	1	MARGINAL