AX-2025-020037 · Ipamorelin · SWB lot SWB-2501-Y7592

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, 25 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 — des-Lys (−128 Da)	0.04	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	711.3856	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	711.3922	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+9.3	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	88.45	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.39	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.21	mg	2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	1.953	mg	2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	97.7	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.79	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	6.36	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.40	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	3.12	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	5.74	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	6.94	min	6.98 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.99	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	71,049	—	≥ 20,000	PASS
Resolution to nearest impurity	vs C-terminal free acid (+1 Da)	1.41	—	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, 25 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 71,049, and skew follows the reported asymmetry factor of 0.99. 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 0.04 % 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	Ipamorelin — main peak	6.94	4,856,908	99.93	—
2	des-Lys (−128 Da)	6.76	1,944	0.04	-128.095
3	C-terminal free acid (+1 Da)	7.09	1,458	0.03	+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 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, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 711.3922 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	356.7034	0.0033	54.8
1+	712.3929	712.3995	0.0066	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.

Component	Determination	%w/w of cake
Water	Karl Fischer	4.79
Counter-ion (acetate)	ion chromatography	6.36
Residual solvent + inorganic residue	estimated	0.40
Total peptide content	by difference	88.45
Total		100.00 CLOSES

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	99.93	divergence -0.22 pp vs batch median
Total impurities (% area)	0.61	0.07
Largest single impurity (% area)	0.41	0.04
Water (%)	2.6	4.79
Counter-ion (%)	not stated	6.36
Peptide content (%w/w)	92.6	88.45
Endotoxin (EU/mg)	not stated	3.12
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, 6 d) → laboratory (courier, cold pack, 6 d) → assay.
Assay date: 24 May 2025
Submitted to the index: 12 Jun 2025
Laboratory: Medutest, Ljubljana, Slovenia
Method basis: 25 min gradient · unit-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

That the compound is not a near-isobaric alternative. Identity was confirmed at unit mass resolution, which cannot exclude species differing by 1 or 2 Da. The specific alternatives not excluded are named in the identity block above.
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.

hplc_ola12 Jun 2025

A longer gradient buys resolution on close-eluting pairs at a linear cost in run time. Medutest ran 25 min here; the reference method runs 30, and the difference is visible in this figure.

plate_count12 Jun 2025

Efficiency is the lever that does not change selectivity, so it improves resolution without moving anything else. Longer column, smaller particle, or lower flow, in that order of cost.

aaa_hydrolysis12 Jun 2025

A closed balance is what converts a purity figure into a mass. 88.39 %w/w target content on a 2 mg claim gives 1.95 mg recovered, and every step of that is on the record.

osmolality_chk12 Jun 2025

Total dissolved solids on reconstitution should reconcile with the balance. Where it does not, the discrepancy is usually an undissolved fraction rather than a measurement error.

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-2025-020034	SWB-2501-Y7592	Janoshik	2025-Q2	99.61	4.50	—	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-2025-020038	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