AX-2024-005238

GHRP-2 · 10 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2404-N2537

FAILVERIFIED

Report ID: AX-2024-005238
Compound: GHRP-2
Compound class: Growth-hormone axis peptides
Supplier: WXT — WuXi TIDES (WuXi AppTec Testing Division)
Batch / lot: WXT-2404-N2537
Declared label claim: 10mg
Laboratory: PeptideMeter
Assay date: 19 Aug 2024
Submitted: 11 Sep 2024
Quarter: 2024-Q3
Submitter: c.moreau
Sample provenance: Laboratory-retained

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, 28 min gradient, 214 nm	98.14	% area	≥ 99.0	FAIL
Total impurities	RP-HPLC, sum of reported peaks	1.86	% area	≤ 1.0	FAIL
Largest single impurity	RP-HPLC — C-terminal free acid (+1 Da)	0.82	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	817.4275	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	817.4255	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-2.4	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	6.16	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.55	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.67	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.49	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	5.47	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 28 min gradient	8.45	min	8.50 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.08	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	75,608	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-2-Nal]-epimer	1.04	—	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, 28 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 75,608, and skew follows the reported asymmetry factor of 1.08. 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 0.82 % impurity against a 98.14 % 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	GHRP-2 — main peak	8.45	4,769,908	98.14	—
2	C-terminal free acid (+1 Da)	8.60	39,855	0.82	+0.984
3	oxidised Trp (+16 Da)	8.11	22,843	0.47	+15.995
4	des-Lys (−128 Da)	8.23	16,525	0.34	-128.095
5	[D-2-Nal]-epimer	8.32	11,179	0.23	0.000
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 817.4275 Da, computed from C45H55N9O6. 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 817.4255 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+	409.7210	409.7200	-0.0010	61.8
1+	818.4348	818.4328	-0.0020	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)	98.37	98.14	divergence -0.20 pp vs batch median
Total impurities (% area)	1.63	1.86
Largest single impurity (% area)	not stated	0.82
Water (%)	not stated	6.16
Counter-ion (%)	3.6	4.55
Peptide content (%w/w)	92.3	not determined
Endotoxin (EU/mg)	not stated	0.49
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: Laboratory-retained
Evidentiary weight: Provenance documented, selection uncontrolled.
Chain of custody: Laboratory retained sample (−20 °C, 31 d since original receipt) → re-assay.
Assay date: 19 Aug 2024
Submitted to the index: 11 Sep 2024
Laboratory: PeptideMeter, Tallinn, Estonia
Method basis: 28 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 2

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.

macrolactam11 Sep 2024

Where the sequence is cyclised, the uncyclised precursor elutes early and is easy to mistake for a truncation. The mass distinguishes the two and this record carries one, so the check costs nothing.

deamidation_rate11 Sep 2024

Deamidation is time, temperature and sequence. If the deamidated species is prominent here, the manufacture date on lot WXT-2404-N2537 against the assay date above is the first arithmetic to do.

Section 7

Related records

Same batch — lot WXT-2404-N2537 n=11

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2024-005231	WXT-2404-N2537	Janoshik	2024-Q3	98.26	6.05	—	Buyer-sourced	FAIL
AX-2024-005232	WXT-2404-N2537	Nordanalyt	2024-Q3	98.43	5.54	—	Buyer-sourced	FAIL
AX-2024-005233	WXT-2404-N2537	VendorInvestigate	2024-Q3	98.52	6.16	—	Buyer-sourced	FAIL
AX-2024-005234	WXT-2404-N2537	Nordanalyt	2024-Q3	98.61	5.81	—	Buyer-sourced	FAIL
AX-2024-005235	WXT-2404-N2537	Janoshik	2024-Q3	98.97	5.51	—	Laboratory-retained	FAIL
AX-2024-005236	WXT-2404-N2537	VendorInvestigate	2024-Q3	97.35	5.64	—	Buyer-sourced	FAIL
AX-2024-005237	WXT-2404-N2537	Medutest	2024-Q3	99.03	5.76	—	Supplier-supplied	PASS
AX-2024-005239	WXT-2404-N2537	VendorInvestigate	2024-Q3	99.03	5.84	—	Buyer-sourced	PASS
AX-2024-005240	WXT-2404-N2537	Janoshik	2024-Q3	98.57	6.12	—	Buyer-sourced	FAIL
AX-2024-005241	WXT-2404-N2537	Janoshik	2024-Q3	98.60	5.74	—	Buyer-sourced	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent GHRP-2 records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043535	SIG	SIG-2603-6031	Janoshik	2026-Q3	99.12	1.26	105.7	Buyer-sourced	0	PASS
AX-2026-043541	SIG	SIG-2603-6031	PeptideMeter	2026-Q3	99.06	2.08	107.4	Buyer-sourced	1	MARGINAL
AX-2026-043539	SIG	SIG-2603-6031	Janoshik	2026-Q3	98.95	1.74	100.4	Buyer-sourced	1	FAIL
AX-2026-043534	SIG	SIG-2603-6031	Medutest	2026-Q3	99.11	2.15	89.8	Buyer-sourced	1	MARGINAL
AX-2026-043542	SIG	SIG-2603-6031	VendorInvestigate	2026-Q3	99.05	1.43	—	Buyer-sourced	1	FAIL
AX-2026-043543	SIG	SIG-2603-6031	Janoshik	2026-Q3	99.38	1.70	98.6	Buyer-sourced	0	PASS
AX-2026-043544	SIG	SIG-2603-6031	PeptideMeter	2026-Q3	99.57	1.51	105.4	Buyer-sourced	0	PASS
AX-2026-043538	SIG	SIG-2603-6031	Kestrel	2026-Q3	98.93	1.72	—	Buyer-sourced	0	FAIL

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