AX-2024-004897

Gonadorelin · 2 mg declared · Shanghai ERP Biotechnology Co., Ltd. · lot ERP-2406-C9933

PASSIDENTITY CONSISTENT

Report ID: AX-2024-004897
Compound: Gonadorelin
Compound class: Hypothalamic and posterior-pituitary hormones
Supplier: ERP — Shanghai ERP Biotechnology Co., Ltd.
Batch / lot: ERP-2406-C9933
Declared label claim: 2mg
Laboratory: VendorInvestigate
Assay date: 03 Sep 2024
Submitted: 13 Sep 2024
Quarter: 2024-Q3
Submitter: c.molnar
Sample provenance: Laboratory-retained

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	99.69	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.31	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — C-terminal free acid (+1 Da)	0.17	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	1181.5825	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	1181.5820	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-0.4	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	3.47	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	3.78	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.70	%	—	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, colourless, no visible particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.56	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 32 min gradient	9.38	min	9.21 ± 0.25 (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	70,959	—	≥ 20,000	PASS
Resolution to nearest impurity	vs C-terminal free acid (+1 Da)	1.18	—	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 70,959, 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 99.69 % 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	9.38	4,845,243	99.69	—
2	C-terminal free acid (+1 Da)	9.55	8,263	0.17	+0.984
3	ring-opened pGlu (+18 Da)	8.89	4,374	0.09	+18.011
4	oxidised Trp (+16 Da)	9.04	1,458	0.03	+15.995
5	des-Gly10-NH2 (−74 Da)	9.08	972	0.02	-74.048
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 1181.5825 Da, computed from C55H75N17O13. 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 1181.5820 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+	394.8681	394.8679	-0.0002	8.7
2+	591.7985	591.7983	-0.0002	57.8
1+	1182.5898	1182.5893	-0.0005	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)	99.72	99.69	divergence -0.08 pp vs batch median
Total impurities (% area)	0.28	0.31
Largest single impurity (% area)	0.11	0.17
Water (%)	2.8	3.47
Counter-ion (%)	not stated	3.78
Peptide content (%w/w)	92.4	not determined
Endotoxin (EU/mg)	0.54	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: Laboratory-retained
Evidentiary weight: Provenance documented, selection uncontrolled.
Chain of custody: Laboratory retained sample (−20 °C, 11 d since original receipt) → re-assay.
Assay date: 03 Sep 2024
Submitted to the index: 13 Sep 2024
Laboratory: VendorInvestigate, Riga, Latvia
Method basis: 32 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 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.

baseline_noise13 Sep 2024

Baseline on this trace is flat enough that the reporting threshold is doing real work rather than hiding peaks in noise. That is a precondition for believing 99.69 % and it is not always met.

racemisation_ala13 Sep 2024

Epimerisation during activation produces a diastereomer that is mass-identical and only chromatographically separable. At this gradient length the separation exists, and 99.69 % is net of it.

quad_unit13 Sep 2024

Instrument class is on the record, which is what allows -0.4 ppm to be read at its proper weight. The index distinguishes "confirmed" from "consistent with" precisely on this field.

Section 7

Related records

Same batch — lot ERP-2406-C9933 n=9

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2024-004891	ERP-2406-C9933	Janoshik	2024-Q3	99.93	3.92	97.0	Buyer-sourced	PASS
AX-2024-004892	ERP-2406-C9933	Nordanalyt	2024-Q3	99.60	3.71	—	Buyer-sourced	PASS
AX-2024-004893	ERP-2406-C9933	Kestrel	2024-Q3	99.93	3.71	96.1	Buyer-sourced	PASS
AX-2024-004894	ERP-2406-C9933	Nordanalyt	2024-Q3	99.93	3.79	106.9	Buyer-sourced	PASS
AX-2024-004895	ERP-2406-C9933	PeptideMeter	2024-Q3	99.93	3.90	96.1	Supplier-supplied	PASS
AX-2024-004896	ERP-2406-C9933	Janoshik	2024-Q3	99.69	3.91	105.0	Buyer-sourced	PASS
AX-2024-004898	ERP-2406-C9933	Janoshik	2024-Q3	99.70	3.54	92.1	Buyer-sourced	PASS
AX-2024-004899	ERP-2406-C9933	Janoshik	2024-Q3	99.80	3.41	91.6	Buyer-sourced	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 ERP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042706	Survodutide	ERP-2605-E9865	PeptideMeter	2026-Q3	98.38	5.33	103.5	Buyer-sourced	0	PASS
AX-2026-042704	Tesamorelin	ERP-2604-W9463	Janoshik	2026-Q3	99.02	4.08	—	Buyer-sourced	1	MARGINAL
AX-2026-042705	Survodutide	ERP-2605-E9865	Janoshik	2026-Q3	98.24	5.36	92.3	Buyer-sourced	0	PASS
AX-2026-042708	GHK-Cu	ERP-2601-F9816	Nordanalyt	2026-Q2	98.88	3.87	91.5	Buyer-sourced	1	MARGINAL
AX-2026-042694	Liraglutide	ERP-2601-P8985	Kestrel	2026-Q2	99.25	4.35	107.3	Buyer-sourced	1	MARGINAL
AX-2026-042707	GHK-Cu	ERP-2601-F9816	Janoshik	2026-Q2	98.53	4.70	96.3	Buyer-sourced	1	MARGINAL
AX-2026-042711	GHK-Cu	ERP-2601-F9816	Kestrel	2026-Q2	98.53	3.84	89.7	Laboratory-retained	2	MARGINAL
AX-2026-042722	Tirzepatide	ERP-2512-T9616	Medutest	2026-Q2	99.18	2.07	—	Buyer-sourced	1	MARGINAL