AX-2025-019294 · Ipamorelin · AMB lot AMB-2505-J6078

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 — C-terminal free acid (+1 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, high resolution (ESI-TOF/QTOF)	711.3871	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+2.1	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	86.38	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	86.32	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.82	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	5.024	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	100.5	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.53	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	8.28	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.81	%	—	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	4.47	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	8.31	min	8.24 ± 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	53,309	—	≥ 20,000	PASS
Resolution to nearest impurity	vs C-terminal free acid (+1 Da)	1.22	—	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 53,309, 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 0.04 % 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	8.31	4,856,908	99.93	—
2	C-terminal free acid (+1 Da)	8.49	1,944	0.04	+0.984
3	oxidised Trp (+16 Da)	7.97	1,458	0.03	+15.995
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 711.3871 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	54.1
1+	712.3929	712.3944	0.0015	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	4.53
Counter-ion (acetate)	ion chromatography	8.28
Residual solvent + inorganic residue	estimated	0.81
Total peptide content	by difference	86.38
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)	99.76	99.93	divergence -0.07 pp vs batch median
Total impurities (% area)	0.24	0.07
Largest single impurity (% area)	0.18	0.04
Water (%)	4.0	4.53
Counter-ion (%)	7.5	8.28
Peptide content (%w/w)	87.9	86.38
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: Laboratory-retained
Evidentiary weight: Provenance documented, selection uncontrolled.
Chain of custody: Laboratory retained sample (−20 °C, 33 d since original receipt) → re-assay.
Assay date: 09 Sep 2025
Submitted to the index: 12 Sep 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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 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.

aib_coupling12 Sep 2025

Hindered couplings are where a synthesis loses purity, and the deletion products they leave are the first thing to look for. On this record they are not there in quantity.

peak_integrator12 Sep 2025

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.

Contributor #M-368412 Sep 2025

The index closes its own mass balance to two decimal places here: water 4.53 %, counter-ion 8.28 % acetate, residual and total peptide content account for 100.00 %. That closure is asserted by the build checker rather than by an author.

Section 7

Related records

Same batch — lot AMB-2505-J6078 n=13

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2025-019291	AMB-2505-J6078	Janoshik	2025-Q3	99.50	5.06	103.8	Buyer-sourced	PASS
AX-2025-019292	AMB-2505-J6078	Janoshik	2025-Q3	99.83	4.33	—	Buyer-sourced	PASS
AX-2025-019293	AMB-2505-J6078	PeptideMeter	2025-Q3	99.54	4.85	98.2	Buyer-sourced	PASS
AX-2025-019295	AMB-2505-J6078	PeptideMeter	2025-Q3	99.93	5.38	—	Buyer-sourced	PASS
AX-2025-019296	AMB-2505-J6078	PeptideMeter	2025-Q3	99.82	4.94	104.3	Buyer-sourced	PASS
AX-2025-019297	AMB-2505-J6078	Janoshik	2025-Q3	99.83	5.10	—	Buyer-sourced	PASS
AX-2025-019298	AMB-2505-J6078	Janoshik	2025-Q3	99.86	5.27	92.7	Buyer-sourced	PASS
AX-2025-019299	AMB-2505-J6078	Medutest	2025-Q3	99.33	4.84	—	Buyer-sourced	PASS
AX-2025-019300	AMB-2505-J6078	Janoshik	2025-Q3	99.41	4.88	103.8	Buyer-sourced	PASS
AX-2025-019301	AMB-2505-J6078	Kestrel	2025-Q3	99.93	4.68	92.5	Buyer-sourced	PASS
AX-2025-019302	AMB-2505-J6078	Janoshik	2025-Q3	99.50	4.75	—	Buyer-sourced	PASS
AX-2025-019303	AMB-2505-J6078	Janoshik	2025-Q3	99.93	4.86	—	Buyer-sourced	PASS

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 AMB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042002	Semaglutide	AMB-2607-N6274	VendorInvestigate	2026-Q3	98.23	6.37	97.1	Buyer-sourced	1	MARGINAL
AX-2026-042012	GHRP-6	AMB-2603-S5667	Janoshik	2026-Q3	99.37	5.90	88.8	Laboratory-retained	1	MARGINAL
AX-2026-041974	Tirzepatide	AMB-2603-C5112	Nordanalyt	2026-Q3	98.20	3.41	—	Buyer-sourced	0	PASS
AX-2026-041975	Tirzepatide	AMB-2603-C5112	Medutest	2026-Q3	97.88	3.45	106.9	Laboratory-retained	0	PASS
AX-2026-042005	Semaglutide	AMB-2607-N6274	PeptideMeter	2026-Q3	98.09	6.48	98.6	Buyer-sourced	1	MARGINAL
AX-2026-042008	Epitalon	AMB-2602-Y6433	Janoshik	2026-Q3	99.30	8.75	105.1	Buyer-sourced	0	PASS
AX-2026-042021	TB-500	AMB-2602-P5987	VendorInvestigate	2026-Q3	99.86	4.79	101.4	Buyer-sourced	0	PASS
AX-2026-042015	GHRP-6	AMB-2603-S5667	Janoshik	2026-Q3	99.54	6.44	97.1	Buyer-sourced	0	PASS