AX-2024-005251 · Ipamorelin · SSA lot SSA-2404-U7946

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	97.72	% area	≥ 99.0	FAIL
Total impurities	RP-HPLC, sum of reported peaks	2.28	% area	≤ 1.0	FAIL
Largest single impurity	RP-HPLC — oxidised Trp (+16 Da)	1.31	% area	≤ 1.00	FAIL
Identity — theoretical monoisotopic mass	calculated from molecular formula	711.3856	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	711.3833	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-3.2	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	89.77	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	87.72	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	11.61	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	10.184	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	101.8	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.59	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.99	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.65	%	—	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	5.00	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	8.33	min	8.24 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.18	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	63,521	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Trp]-epimer	0.89	—	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 63,521, and skew follows the reported asymmetry factor of 1.18. 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 1.31 % impurity against a 97.72 % 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	8.33	4,749,495	97.72	—
2	oxidised Trp (+16 Da)	7.99	63,670	1.31	+15.995
3	C-terminal free acid (+1 Da)	8.51	18,955	0.39	+0.984
4	des-Lys (−128 Da)	8.11	13,123	0.27	-128.095
5	[D-Trp]-epimer	8.21	10,207	0.21	0.000
6	Aib-deletion sequence (−85 Da)	8.05	4,860	0.10	-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 711.3833 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	356.6989	-0.0012	55.3
1+	712.3929	712.3906	-0.0023	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	4.59
Counter-ion (acetate)	ion chromatography	4.99
Residual solvent + inorganic residue	estimated	0.65
Total peptide content	by difference	89.77
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)	98.5	97.72	divergence +0.32 pp vs batch median
Total impurities (% area)	1.50	2.28
Largest single impurity (% area)	0.78	1.31
Water (%)	2.4	4.59
Counter-ion (%)	not stated	4.99
Peptide content (%w/w)	not stated	89.77
Endotoxin (EU/mg)	0.61	not determined
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 2 d) → assay. Submitter did not handle the vial.
Assay date: 04 Aug 2024
Submitted to the index: 26 Aug 2024
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

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot SSA-2404-U7946 n=14

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005246	SSA-2404-U7946	Medutest	2024-Q3	98.13	4.92	—	Supplier-supplied	2	FAIL
AX-2024-005247	SSA-2404-U7946	Nordanalyt	2024-Q3	98.57	4.64	106.2	Supplier-supplied	2	FAIL
AX-2024-005248	SSA-2404-U7946	Janoshik	2024-Q3	98.12	4.74	—	Supplier-supplied	2	FAIL
AX-2024-005249	SSA-2404-U7946	Kestrel	2024-Q3	98.45	4.80	—	Supplier-supplied	2	FAIL
AX-2024-005250	SSA-2404-U7946	Medutest	2024-Q3	98.89	4.86	89.1	Supplier-supplied	3	FAIL
AX-2024-005252	SSA-2404-U7946	Kestrel	2024-Q3	99.30	4.24	98.9	Supplier-supplied	2	MARGINAL
AX-2024-005253	SSA-2404-U7946	Janoshik	2024-Q3	97.86	4.87	—	Buyer-sourced	2	FAIL
AX-2024-005254	SSA-2404-U7946	Janoshik	2024-Q3	98.01	4.17	—	Supplier-supplied	2	FAIL
AX-2024-005255	SSA-2404-U7946	Janoshik	2024-Q3	97.83	4.64	101.7	Supplier-supplied	2	FAIL
AX-2024-005256	SSA-2404-U7946	PeptideMeter	2024-Q3	98.30	4.40	93.5	Supplier-supplied	2	FAIL
AX-2024-005257	SSA-2404-U7946	Janoshik	2024-Q3	98.23	4.68	106.3	Supplier-supplied	3	FAIL
AX-2024-005258	SSA-2404-U7946	Kestrel	2024-Q3	99.03	4.66	98.1	Supplier-supplied	3	MARGINAL
AX-2024-005259	SSA-2404-U7946	Janoshik	2024-Q3	97.61	4.51	90.2	Supplier-supplied	2	FAIL

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-2026-042181	Homopeptide	HOMO-2608-A9045	Janoshik	2026-Q3	99.78	4.79	—	Supplier-supplied	1	MARGINAL
AX-2026-042180	Homopeptide	HOMO-2608-A9045	Janoshik	2026-Q3	99.39	4.74	105.5	Supplier-supplied	1	MARGINAL
AX-2026-042184	Homopeptide	HOMO-2608-A9045	Kestrel	2026-Q3	99.27	4.79	103.2	Supplier-supplied	1	MARGINAL
AX-2026-041427	QYB	QYB-2605-H4298	Janoshik	2026-Q3	99.93	4.12	—	Supplier-supplied	0	PASS
AX-2026-042183	Homopeptide	HOMO-2608-A9045	VendorInvestigate	2026-Q3	99.38	4.97	—	Buyer-sourced	1	MARGINAL
AX-2026-043090	KP	KP-2606-D5887	Janoshik	2026-Q3	98.18	3.07	101.2	Laboratory-retained	1	FAIL
AX-2026-042191	Homopeptide	HOMO-2608-A9045	Medutest	2026-Q3	99.67	5.00	104.6	Supplier-supplied	1	MARGINAL
AX-2026-041425	QYB	QYB-2605-H4298	Janoshik	2026-Q3	99.93	3.65	93.4	Supplier-supplied	0	PASS

Other recent SSA records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043144	GHK-Cu	SSA-2604-V7620	Janoshik	2026-Q2	98.35	5.25	105.8	Supplier-supplied	0	PASS
AX-2026-043141	Semax	SSA-2604-L7628	Kestrel	2026-Q2	98.84	8.58	93.2	Supplier-supplied	2	MARGINAL
AX-2026-043117	Mazdutide	SSA-2605-G6781	Janoshik	2026-Q2	99.23	3.67	90.4	Supplier-supplied	1	MARGINAL
AX-2026-043136	BPC-157	SSA-2601-N6752	Janoshik	2026-Q2	97.75	4.32	—	Supplier-supplied	2	FAIL
AX-2026-043118	Mazdutide	SSA-2605-G6781	Medutest	2026-Q2	98.29	2.65	88.7	Buyer-sourced	2	MARGINAL
AX-2026-043138	BPC-157	SSA-2601-N6752	Janoshik	2026-Q2	98.00	4.30	101.0	Supplier-supplied	1	MARGINAL
AX-2026-043137	BPC-157	SSA-2601-N6752	Janoshik	2026-Q2	97.41	4.36	104.5	Laboratory-retained	1	FAIL
AX-2026-043146	Enclomiphene citrate	SSA-2603-C6950	Medutest	2026-Q2	97.92	3.11	92.9	Buyer-sourced	2	FAIL