AX-2026-043453 · Gonadorelin · BCH lot BCH-2510-F4167

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, 25 min gradient, 214 nm	98.79	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.21	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — oxidised Trp (+16 Da)	0.61	% 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	89.80	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.71	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.01	mg	2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	1.783	mg	2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	89.1	%	90.0 – 110.0	FAIL
Water content	Karl Fischer, coulometric, duplicate	4.79	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.53	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.88	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
Sterility	membrane filtration, USP <71>, 14 d	No growth at 14 d	—	no growth	PASS
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	5.71	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	7.33	min	7.35 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.93	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	72,731	—	≥ 20,000	PASS
Resolution to nearest impurity	vs C-terminal free acid (+1 Da)	1.20	—	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, 25 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 72,731, and skew follows the reported asymmetry factor of 0.93. 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 0.61 % impurity against a 98.79 % 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	Gonadorelin — main peak	7.33	4,801,500	98.79	—
2	oxidised Trp (+16 Da)	7.06	29,648	0.61	+15.995
3	ring-opened pGlu (+18 Da)	6.95	17,011	0.35	+18.011
4	des-Gly10-NH2 (−74 Da)	7.10	6,318	0.13	-74.048
5	C-terminal free acid (+1 Da)	7.46	5,832	0.12	+0.984
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	4.79
Counter-ion (acetate)	ion chromatography	4.53
Residual solvent + inorganic residue	estimated	0.88
Total peptide content	by difference	89.80
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)	99.16	98.79	divergence +0.27 pp vs batch median
Total impurities (% area)	not stated	1.21
Largest single impurity (% area)	not stated	0.61
Water (%)	not stated	4.79
Counter-ion (%)	2.7	4.53
Peptide content (%w/w)	93.2	89.80
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, 17 d) → laboratory (courier, cold pack, 8 d) → assay.
Assay date: 16 Dec 2025
Submitted to the index: 05 Jan 2026
Laboratory: Medutest, Ljubljana, Slovenia
Method basis: 25 min gradient · unit-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 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.

shipping_temp05 Jan 2026

The custody block above records the shipping conditions this vial actually experienced, which is the condition an ordinary buyer's vial experiences too. That representativeness is the point.

valley_drop05 Jan 2026

The reported figure derives from the plate count and the retention gap, via the pharmacopoeial form with the sum of both peak widths in the denominator. It is a calculated quantity, not a measured one, and it inherits the plate count's uncertainty.

plate_count05 Jan 2026

Where the plate count is low the resolution figure is low for a reason that has nothing to do with the impurity profile. Read the two together or read neither.

Section 7

Related records

Same batch — lot BCH-2510-F4167 n=14

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-021044	BCH-2510-F4167	Janoshik	2025-Q4	98.89	5.51	—	Buyer-sourced	0	PASS
AX-2025-021045	BCH-2510-F4167	Medutest	2025-Q4	98.88	5.10	99.9	Buyer-sourced	0	PASS
AX-2026-043452	BCH-2510-F4167	Janoshik	2025-Q4	98.25	4.78	94.8	Buyer-sourced	0	FAIL
AX-2025-021046	BCH-2510-F4167	Medutest	2025-Q4	99.15	4.96	107.4	Supplier-supplied	0	PASS
AX-2025-021047	BCH-2510-F4167	Janoshik	2025-Q4	99.07	5.56	—	Buyer-sourced	0	PASS
AX-2025-021048	BCH-2510-F4167	Medutest	2025-Q4	98.57	5.68	104.3	Buyer-sourced	0	PASS
AX-2025-021049	BCH-2510-F4167	VendorInvestigate	2025-Q4	99.10	5.07	—	Buyer-sourced	0	PASS
AX-2025-021050	BCH-2510-F4167	VendorInvestigate	2025-Q4	98.49	5.24	94.7	Buyer-sourced	0	FAIL
AX-2025-021051	BCH-2510-F4167	Janoshik	2025-Q4	99.31	5.03	—	Supplier-supplied	1	MARGINAL
AX-2025-021052	BCH-2510-F4167	Kestrel	2025-Q4	98.94	4.94	104.3	Buyer-sourced	0	PASS
AX-2025-021053	BCH-2510-F4167	Janoshik	2025-Q4	99.18	5.32	94.3	Supplier-supplied	0	PASS
AX-2025-021054	BCH-2510-F4167	Janoshik	2025-Q4	98.69	5.65	102.6	Buyer-sourced	0	PASS
AX-2025-021055	BCH-2510-F4167	Janoshik	2025-Q4	98.79	5.32	—	Buyer-sourced	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Gonadorelin records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042327	TFC	TFC-2511-E2186	Kestrel	2026-Q2	99.75	2.76	—	Buyer-sourced	0	PASS
AX-2026-042971	MKM	MKM-2604-A3595	Nordanalyt	2026-Q2	99.50	5.15	—	Buyer-sourced	0	PASS
AX-2026-042970	MKM	MKM-2604-A3595	PeptideMeter	2026-Q2	99.34	4.95	90.8	Laboratory-retained	0	PASS
AX-2026-042328	TFC	TFC-2511-E2186	Janoshik	2026-Q2	99.65	2.29	98.4	Laboratory-retained	0	PASS
AX-2026-043338	CPC	CPC-2508-B2206	Janoshik	2026-Q1	98.84	4.00	—	Buyer-sourced	0	PASS
AX-2026-043336	CPC	CPC-2508-B2206	Janoshik	2026-Q1	98.79	4.15	—	Buyer-sourced	0	PASS
AX-2026-043337	CPC	CPC-2508-B2206	PeptideMeter	2026-Q1	98.96	4.20	88.6	Buyer-sourced	1	MARGINAL
AX-2026-043452	BCH	BCH-2510-F4167	Janoshik	2025-Q4	98.25	4.78	94.8	Buyer-sourced	0	FAIL

Other recent BCH records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043445	BPC-157	BCH-2603-G4350	Nordanalyt	2026-Q3	98.42	4.87	93.6	Buyer-sourced	1	MARGINAL
AX-2026-043440	BPC-157	BCH-2603-G4350	VendorInvestigate	2026-Q3	98.61	4.11	—	Buyer-sourced	1	MARGINAL
AX-2026-043442	BPC-157	BCH-2603-G4350	Janoshik	2026-Q3	98.65	4.78	—	Buyer-sourced	1	MARGINAL
AX-2026-043471	CJC-1295 with DAC	BCH-2607-H5235	Janoshik	2026-Q3	97.46	5.48	—	Buyer-sourced	1	FAIL
AX-2026-043477	CJC-1295 with DAC	BCH-2607-H5235	VendorInvestigate	2026-Q3	97.62	5.32	99.6	Buyer-sourced	1	MARGINAL
AX-2026-043449	BPC-157	BCH-2603-G4350	Kestrel	2026-Q3	99.74	4.92	91.3	Supplier-supplied	2	MARGINAL
AX-2026-043448	BPC-157	BCH-2603-G4350	Janoshik	2026-Q3	98.55	4.69	106.9	Buyer-sourced	1	MARGINAL
AX-2026-043470	CJC-1295 with DAC	BCH-2607-H5235	Janoshik	2026-Q3	97.76	6.11	99.3	Supplier-supplied	1	MARGINAL