AX-2024-004538

Hexarelin · 2 mg declared · Shenzhen Hybio Pharmaceutical Co., Ltd. · lot HYB-2407-N7367

MARGINALIDENTITY CONSISTENT

Report ID: AX-2024-004538
Compound: Hexarelin
Compound class: Growth-hormone axis peptides
Supplier: HYB — Shenzhen Hybio Pharmaceutical Co., Ltd.
Batch / lot: HYB-2407-N7367
Declared label claim: 2mg
Laboratory: Janoshik Analytical
Assay date: 04 Aug 2024
Submitted: 20 Aug 2024
Quarter: 2024-Q3
Submitter: s.sorensen
Sample provenance: Buyer-sourced

Section 1

Results

Measured against the index acceptance specification for the growth-hormone axis peptides 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	99.93	% area	≥ 99.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.07	% area	≤ 1.0	PASS
Largest single impurity	RP-HPLC — oxidised Trp (+16 Da)	0.05	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	886.4602	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	886.4606	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	5.12	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.95	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.55	%	—	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	5.53	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	8.41	min	8.92 ± 0.25 (normalised)	FAIL
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.28	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	62,068	—	≥ 20,000	PASS
Resolution to nearest impurity	vs C-terminal free acid (+1 Da)	1.16	—	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 62,068, and skew follows the reported asymmetry factor of 1.28. 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 0.05 % impurity against a 99.93 % 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	Hexarelin — main peak	8.41	4,856,908	99.93	—
2	oxidised Trp (+16 Da)	8.07	2,430	0.05	+15.995
3	C-terminal free acid (+1 Da)	8.57	972	0.02	+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 3

Mass spectrum and identity

Theoretical monoisotopic mass 886.4602 Da, computed from C47H58N12O6. 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 886.4606 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 (%)
2+	444.2374	444.2376	0.0002	56.5
1+	887.4675	887.4679	0.0004	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)	99.58	99.93	divergence -0.35 pp vs batch median
Total impurities (% area)	0.42	0.07
Largest single impurity (% area)	not stated	0.05
Water (%)	not stated	5.12
Counter-ion (%)	not stated	5.95
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	0.26	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 → third-party forwarder (15 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date: 04 Aug 2024
Submitted to the index: 20 Aug 2024
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 4

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.

sig_figs20 Aug 2024

Two decimal places on 99.93 % implies repeatability better than 0.01 pp, which no laboratory here claims. The number is sound; the printed precision is more than the method carries.

Index data team

Two decimal places are retained because the source reports carry them and truncating would discard information where a laboratory genuinely reports it. The uncertainty budget on /methods/uncertainty-budget/ is the right thing to read alongside any purity figure on this site.

lot_traceability20 Aug 2024

The index cannot verify that the vial assayed is representative of the lot it came from, and says so on every record. Provenance narrows that gap; it does not close it.

peak_integrator20 Aug 2024

Resolution to the nearest named impurity is reported on this record with no verdict attached, which is the correct handling. A threshold on that figure would penalise compounds for their own impurity profiles.

baseline_noise20 Aug 2024

On a low-resolution pair the baseline between the peaks never reaches baseline, so any integration is an extrapolation. Stating which extrapolation was used is worth more than any threshold.

Section 7

Related records

Same batch — lot HYB-2407-N7367 n=11

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2024-004534	HYB-2407-N7367	Janoshik	2024-Q3	99.93	4.71	102.5	Buyer-sourced	PASS
AX-2024-004535	HYB-2407-N7367	Janoshik	2024-Q3	99.93	4.83	92.5	Buyer-sourced	PASS
AX-2024-004536	HYB-2407-N7367	Janoshik	2024-Q3	99.93	5.50	105.9	Buyer-sourced	PASS
AX-2024-004537	HYB-2407-N7367	Janoshik	2024-Q3	99.77	4.67	95.0	Buyer-sourced	PASS
AX-2024-004539	HYB-2407-N7367	VendorInvestigate	2024-Q3	99.88	4.99	—	Buyer-sourced	PASS
AX-2024-004540	HYB-2407-N7367	Kestrel	2024-Q3	99.80	5.35	—	Buyer-sourced	PASS
AX-2024-004541	HYB-2407-N7367	Janoshik	2024-Q3	99.93	5.44	—	Buyer-sourced	PASS
AX-2024-004542	HYB-2407-N7367	PeptideMeter	2024-Q3	99.35	5.55	—	Buyer-sourced	PASS
AX-2024-004543	HYB-2407-N7367	PeptideMeter	2024-Q3	99.93	5.19	95.3	Buyer-sourced	PASS
AX-2024-004544	HYB-2407-N7367	PeptideMeter	2024-Q3	99.77	5.05	102.9	Buyer-sourced	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Hexarelin records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042177	JEEP	JEEP-2608-Y9547	Janoshik	2026-Q3	99.90	3.42	—	Buyer-sourced	PASS
AX-2026-042178	JEEP	JEEP-2608-Y9547	VendorInvestigate	2026-Q3	99.68	4.03	—	Buyer-sourced	PASS
AX-2026-043097	KP	KP-2604-X5990	Medutest	2026-Q2	99.55	2.60	—	Laboratory-retained	PASS
AX-2026-043253	CPC	CPC-2511-F9455	Janoshik	2026-Q2	98.53	6.11	—	Buyer-sourced	FAIL
AX-2026-043098	KP	KP-2604-X5990	PeptideMeter	2026-Q2	98.66	3.14	—	Buyer-sourced	FAIL
AX-2026-042366	Homopeptide	HOMO-2602-R3080	Janoshik	2026-Q2	99.55	4.14	—	Buyer-sourced	PASS
AX-2026-042365	Homopeptide	HOMO-2602-R3080	PeptideMeter	2026-Q2	99.66	4.44	94.8	Buyer-sourced	PASS
AX-2026-043100	KP	KP-2604-X5990	Janoshik	2026-Q2	98.82	3.57	92.0	Buyer-sourced	FAIL

Other recent HYB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042083	MOTS-c	HYB-2606-D7858	Medutest	2026-Q3	99.93	2.02	—	Buyer-sourced	0	PASS
AX-2026-042090	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.57	2.36	—	Buyer-sourced	1	FAIL
AX-2026-042084	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.28	2.79	107.3	Buyer-sourced	0	PASS
AX-2026-042087	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.54	3.05	—	Buyer-sourced	0	PASS
AX-2026-042085	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.51	2.31	—	Buyer-sourced	0	PASS
AX-2026-042088	MOTS-c	HYB-2606-D7858	PeptideMeter	2026-Q3	99.22	2.21	—	Buyer-sourced	0	PASS
AX-2026-042086	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.93	3.02	—	Buyer-sourced	1	MARGINAL
AX-2026-042091	CJC-1295 with DAC	HYB-2608-E7391	Janoshik	2026-Q3	99.38	5.53	—	Buyer-sourced	0	PASS