AX-2026-042971

Gonadorelin · 2 mg declared · Xi'an Mokemei Biotechnology Co., Ltd. · lot MKM-2604-A3595

PASSVERIFIED

Report ID: AX-2026-042971
Compound: Gonadorelin
Compound class: Hypothalamic and posterior-pituitary hormones
Supplier: MKM — Xi'an Mokemei Biotechnology Co., Ltd.
Batch / lot: MKM-2604-A3595
Declared label claim: 2mg
Laboratory: Nordanalyt Laboratories
Assay date: 16 May 2026
Submitted: 18 May 2026
Quarter: 2026-Q2
Submitter: enclomi_isomer
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, 35 min gradient, 214 nm	99.50	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.50	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — oxidised Trp (+16 Da)	0.20	% 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)	1181.5831	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+0.5	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	5.15	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.41	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.66	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.93	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 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	5.13	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	9.91	min	10.01 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.00	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	98,607	—	≥ 20,000	PASS
Resolution to nearest impurity	vs C-terminal free acid (+1 Da)	1.44	—	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, 35 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 98,607, and skew follows the reported asymmetry factor of 1.00. 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 0.20 % impurity against a 99.50 % 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	9.91	4,836,008	99.50	—
2	oxidised Trp (+16 Da)	9.54	9,721	0.20	+15.995
3	ring-opened pGlu (+18 Da)	9.37	8,749	0.18	+18.011
4	C-terminal free acid (+1 Da)	10.10	3,402	0.07	+0.984
5	des-Gly10-NH2 (−74 Da)	9.58	2,430	0.05	-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 1181.5831 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	394.8683	0.0002	9.2
2+	591.7985	591.7988	0.0003	61.6
1+	1182.5898	1182.5904	0.0006	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	99.50	divergence -0.15 pp vs batch median
Total impurities (% area)	0.73	0.50
Largest single impurity (% area)	not stated	0.20
Water (%)	4.1	5.15
Counter-ion (%)	7.1	4.41
Peptide content (%w/w)	88.2	not determined
Endotoxin (EU/mg)	not stated	0.93
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: Retail purchase → submitter (−20 °C, 13 d) → laboratory (courier, dry ice, 3 d) → assay.
Assay date: 16 May 2026
Submitted to the index: 18 May 2026
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 min gradient · high-resolution MS
Verification status: VERIFIED

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 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.

ppm_error18 May 2026

Well inside class limit. Worth noting that the class limits are set by mass rather than globally, because the same ppm is a different number of daltons at 340 and at 4,800.

sodium_adduct18 May 2026

Mass, retention and impurity profile all agree on this record. Three independent constraints pointing the same way is the strongest identity evidence the index publishes.

quad_unit18 May 2026

The index grades identity by instrument class, not by the ppm figure alone: "confirmed" where the determination was made at high resolution, "consistent with" where it was not. The status block above says which applies to this record, and it is worth reading before the number.

Section 7

Related records

Same batch — lot MKM-2604-A3595 n=2

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042970	MKM-2604-A3595	PeptideMeter	2026-Q2	99.34	4.95	90.8	Laboratory-retained	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-2026-042970	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
AX-2026-043453	BCH	BCH-2510-F4167	Medutest	2025-Q4	98.79	4.79	89.1	Buyer-sourced	1	MARGINAL

Other recent MKM records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042942	CJC-1295 (no DAC)	MKM-2603-V3346	Janoshik	2026-Q3	99.52	3.43	—	Supplier-supplied	PASS
AX-2026-043019	Adipotide	MKM-2606-K5012	Janoshik	2026-Q3	97.61	5.77	105.1	Buyer-sourced	PASS
AX-2026-042939	CJC-1295 (no DAC)	MKM-2603-V3346	PeptideMeter	2026-Q3	99.44	3.39	—	Buyer-sourced	PASS
AX-2026-043020	Adipotide	MKM-2606-K5012	Medutest	2026-Q3	97.73	5.74	—	Buyer-sourced	PASS
AX-2026-043022	Adipotide	MKM-2606-K5012	Kestrel	2026-Q3	97.69	6.33	106.9	Buyer-sourced	PASS
AX-2026-043023	Adipotide	MKM-2606-K5012	Medutest	2026-Q3	97.48	5.56	103.7	Supplier-supplied	PASS
AX-2026-042945	CJC-1295 (no DAC)	MKM-2603-V3346	PeptideMeter	2026-Q3	99.39	3.54	—	Laboratory-retained	PASS
AX-2026-042938	CJC-1295 (no DAC)	MKM-2603-V3346	Nordanalyt	2026-Q3	99.47	3.67	95.0	Buyer-sourced	PASS