AX-2025-020034

Ipamorelin · 2 mg declared · Shanghai Wibson Biotechnology Co., Ltd. · lot SWB-2501-Y7592

MARGINALIDENTITY CONSISTENT

Report ID: AX-2025-020034
Compound: Ipamorelin
Compound class: Growth-hormone axis peptides
Supplier: SWB — Shanghai Wibson Biotechnology Co., Ltd.
Batch / lot: SWB-2501-Y7592
Declared label claim: 2mg
Laboratory: Janoshik Analytical
Assay date: 02 Jun 2025
Submitted: 09 Jun 2025
Quarter: 2025-Q2
Submitter: Contributor #J-2856
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	99.61	% area	≥ 99.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.39	% area	≤ 1.0	PASS
Largest single impurity	RP-HPLC — des-Lys (−128 Da)	0.25	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	711.3856	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	711.3870	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+1.9	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	4.50	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.36	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.80	%	—	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 cake, partially collapsed	—	white to off-white intact cake	FAIL
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	4.78	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	8.24	min	8.24 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.17	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	54,291	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Trp]-epimer	0.83	—	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 54,291, and skew follows the reported asymmetry factor of 1.17. 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 0.25 % impurity against a 99.61 % 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	Ipamorelin — main peak	8.24	4,841,355	99.61	—
2	des-Lys (−128 Da)	8.02	12,151	0.25	-128.095
3	oxidised Trp (+16 Da)	7.90	3,402	0.07	+15.995
4	[D-Trp]-epimer	8.12	1,944	0.04	0.000
5	Aib-deletion sequence (−85 Da)	7.96	1,458	0.03	-85.053
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 711.3856 Da, computed from C38H49N9O5. 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 711.3870 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+	356.7001	356.7008	0.0007	54.8
1+	712.3929	712.3943	0.0014	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)	99.39	99.61	divergence -0.22 pp vs batch median
Total impurities (% area)	0.61	0.39
Largest single impurity (% area)	0.41	0.25
Water (%)	2.6	4.50
Counter-ion (%)	not stated	5.36
Peptide content (%w/w)	92.6	not determined
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: Domestic warehouse despatch → submitter (2–8 °C, 29 d) → laboratory (courier, cold pack, 2 d) → assay.
Assay date: 02 Jun 2025
Submitted to the index: 09 Jun 2025
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.

wide_iqr09 Jun 2025

A single result at 99.61 % is one draw. What makes a supplier's process legible is the spread across its lots, and that is on the scorecard rather than here. This record is one good point in a distribution worth reading whole.

baseline_noise09 Jun 2025

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 99.61 % and it is not always met.

nmr_qnmr09 Jun 2025

Mass at +1.9 ppm establishes identity but not content. Absolute content needs a standard or an orthogonal quantitative method, and neither is a mass spectrometer.

lambda_21409 Jun 2025

Detection wavelength does not affect a mass determination but it does affect the purity figure sitting next to it. Both are stated on this record, which is the point.

Section 7

Related records

Same batch — lot SWB-2501-Y7592 n=13

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020027	SWB-2501-Y7592	Janoshik	2025-Q2	99.47	4.80	—	Buyer-sourced	1	MARGINAL
AX-2025-020028	SWB-2501-Y7592	Medutest	2025-Q2	99.72	4.28	100.6	Buyer-sourced	1	MARGINAL
AX-2025-020029	SWB-2501-Y7592	Janoshik	2025-Q2	99.49	4.20	104.1	Buyer-sourced	1	MARGINAL
AX-2025-020030	SWB-2501-Y7592	VendorInvestigate	2025-Q2	99.17	4.12	101.1	Buyer-sourced	1	MARGINAL
AX-2025-020031	SWB-2501-Y7592	Medutest	2025-Q2	99.74	3.53	—	Buyer-sourced	1	MARGINAL
AX-2025-020032	SWB-2501-Y7592	Janoshik	2025-Q2	99.54	4.77	89.9	Buyer-sourced	2	MARGINAL
AX-2025-020033	SWB-2501-Y7592	Janoshik	2025-Q2	99.60	4.31	95.4	Buyer-sourced	1	MARGINAL
AX-2025-020035	SWB-2501-Y7592	Janoshik	2025-Q2	99.73	4.55	104.2	Buyer-sourced	1	MARGINAL
AX-2025-020036	SWB-2501-Y7592	Janoshik	2025-Q2	99.47	4.00	—	Buyer-sourced	1	MARGINAL
AX-2025-020037	SWB-2501-Y7592	Medutest	2025-Q2	99.93	4.79	97.7	Buyer-sourced	1	MARGINAL
AX-2025-020038	SWB-2501-Y7592	Janoshik	2025-Q2	99.70	4.62	—	Buyer-sourced	1	MARGINAL
AX-2025-020039	SWB-2501-Y7592	Medutest	2025-Q2	99.93	3.72	—	Buyer-sourced	1	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Ipamorelin records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041377	QYB	QYB-2605-H3558	Nordanalyt	2026-Q3	99.93	4.35	—	Buyer-sourced	0	PASS
AX-2026-041913	SinoPep	SNP-2606-L4478	PeptideMeter	2026-Q3	98.88	5.28	—	Buyer-sourced	0	FAIL
AX-2026-041914	SinoPep	SNP-2606-L4478	Janoshik	2026-Q3	99.14	5.49	—	Buyer-sourced	0	PASS
AX-2026-041909	SinoPep	SNP-2606-L4478	PeptideMeter	2026-Q3	99.00	5.48	89.5	Buyer-sourced	1	MARGINAL
AX-2026-041895	SinoPep	SNP-2602-B3833	Janoshik	2026-Q3	99.93	4.72	105.9	Buyer-sourced	1	MARGINAL
AX-2026-041898	SinoPep	SNP-2602-B3833	Nordanalyt	2026-Q3	99.93	4.54	96.0	Buyer-sourced	1	MARGINAL
AX-2026-041899	SinoPep	SNP-2602-B3833	PeptideMeter	2026-Q3	99.93	4.96	90.1	Buyer-sourced	1	MARGINAL
AX-2026-041891	SinoPep	SNP-2602-B3833	Janoshik	2026-Q3	99.93	5.11	—	Buyer-sourced	1	MARGINAL

Other recent SWB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042637	Semaglutide	SWB-2602-X7905	Janoshik	2026-Q3	98.37	4.26	102.9	Buyer-sourced	PASS
AX-2026-042645	Semaglutide	SWB-2602-X7905	Medutest	2026-Q3	98.48	4.52	95.2	Buyer-sourced	PASS
AX-2026-042642	Semaglutide	SWB-2602-X7905	PeptideMeter	2026-Q3	97.96	4.48	90.8	Buyer-sourced	PASS
AX-2026-042640	Semaglutide	SWB-2602-X7905	PeptideMeter	2026-Q3	98.55	4.29	—	Buyer-sourced	PASS
AX-2026-042638	Semaglutide	SWB-2602-X7905	Janoshik	2026-Q3	98.74	3.65	—	Buyer-sourced	PASS
AX-2026-042639	Semaglutide	SWB-2602-X7905	Janoshik	2026-Q3	98.77	4.21	—	Supplier-supplied	PASS
AX-2026-042641	Semaglutide	SWB-2602-X7905	Janoshik	2026-Q3	98.86	4.48	99.1	Buyer-sourced	PASS
AX-2026-042644	Semaglutide	SWB-2602-X7905	PeptideMeter	2026-Q3	98.76	3.57	97.7	Buyer-sourced	PASS