AX-2024-004722

Retatrutide · 15 mg declared · Hunan Aslsen Technology Co., Ltd. · lot HOMO-2405-B3923

MARGINALPURITY ONLY

Report ID: AX-2024-004722
Compound: Retatrutide
Compound class: Incretin analogues and co-agonists
Supplier: Homopeptide — Hunan Aslsen Technology Co., Ltd.
Batch / lot: HOMO-2405-B3923
Declared label claim: 15mg
Laboratory: Janoshik Analytical
Assay date: 11 Sep 2024
Submitted: 16 Sep 2024
Quarter: 2024-Q3
Submitter: r.kaufmann
Sample provenance: Laboratory-retained

Section 1

Results

Measured against the index acceptance specification for the incretin analogues and co-agonists 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	97.92	% area	≥ 96.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	2.08	% area	≤ 3.5	PASS
Largest single impurity	RP-HPLC — [D-Aib2]-diastereomer	0.98	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	82.63	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	80.91	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	16.45	mg	15 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	13.310	mg	15 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	88.7	%	90.0 – 110.0	FAIL
Water content	Karl Fischer, coulometric, duplicate	7.42	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	9.65	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.30	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	3.61	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 powder, no defined cake (melt-back)	—	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	3.86	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	20.59	min	20.71 ± 0.50 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.25	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	57,670	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib2]-diastereomer	0.63	—	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 57,670, and skew follows the reported asymmetry factor of 1.25. 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 0.98 % impurity against a 97.92 % 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	Retatrutide — main peak	20.59	4,759,216	97.92	—
2	[D-Aib2]-diastereomer	20.37	47,631	0.98	0.000
3	incomplete Fmoc removal (+222 Da)	23.00	34,022	0.70	+222.068
4	oxidised Trp (+16 Da)	19.93	9,235	0.19	+15.995
5	retatrutide dimer	24.71	6,318	0.13	+4728.487
6	C18 diacid regioisomer	21.17	2,430	0.05	0.000
7	des-Aib20 analogue	20.15	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 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	7.42
Counter-ion (TFA)	ion chromatography	9.65
Residual solvent + inorganic residue	estimated	0.30
Total peptide content	by difference	82.63
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)	98.29	97.92	divergence +0.29 pp vs batch median
Total impurities (% area)	1.71	2.08
Largest single impurity (% area)	1.05	0.98
Water (%)	5.5	7.42
Counter-ion (%)	not stated	9.65
Peptide content (%w/w)	not stated	82.63
Endotoxin (EU/mg)	not stated	3.61
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, 22 d since original receipt) → re-assay.
Assay date: 11 Sep 2024
Submitted to the index: 16 Sep 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: PURITY ONLY

What this report does not establish

That the compound is the compound named. No identity confirmation was ordered on this submission. A purity figure describes chromatographic homogeneity of whatever eluted; it does not name 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 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.

c18_2p616 Sep 2024

Core-shell packing at 2.6 µm gains roughly 40 % in resolution over a 5 µm fully porous bed at the same length and pressure. On a pair this close, that is the difference between two peaks and one.

diode_array16 Sep 2024

Peak purity by spectral comparison across the main peak flags co-elution where chromatography cannot resolve it. It does not quantify the co-eluting species, but it establishes that one exists.

Section 7

Related records

Same batch — lot HOMO-2405-B3923 n=6

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004721	HOMO-2405-B3923	VendorInvestigate	2024-Q3	98.34	6.34	—	Buyer-sourced	0	PASS
AX-2024-004723	HOMO-2405-B3923	PeptideMeter	2024-Q3	97.93	5.54	—	Buyer-sourced	0	PASS
AX-2024-004724	HOMO-2405-B3923	Medutest	2024-Q3	97.83	6.10	101.2	Buyer-sourced	1	FAIL
AX-2024-004725	HOMO-2405-B3923	PeptideMeter	2024-Q3	98.11	6.42	107.2	Buyer-sourced	0	PASS
AX-2024-004726	HOMO-2405-B3923	Medutest	2024-Q3	98.06	6.32	99.3	Laboratory-retained	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Retatrutide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042437	Homopeptide	HOMO-2605-V4718	Nordanalyt	2026-Q3	98.68	3.67	102.8	Buyer-sourced	PASS
AX-2026-043095	KP	KP-2607-H5774	Janoshik	2026-Q3	95.81	5.48	105.2	Buyer-sourced	FAIL
AX-2026-042282	TFC	TFC-2608-J1156	Janoshik	2026-Q3	98.54	4.27	—	Buyer-sourced	PASS
AX-2026-043094	KP	KP-2607-H5774	PeptideMeter	2026-Q3	96.32	6.40	—	Buyer-sourced	FAIL
AX-2026-042441	Homopeptide	HOMO-2605-V4718	Medutest	2026-Q3	98.93	4.22	—	Buyer-sourced	PASS
AX-2026-041427	QYB	QYB-2604-B4920	PeptideMeter	2026-Q3	97.93	2.45	101.7	Buyer-sourced	PASS
AX-2026-041786	ASY	ASY-{CAT}-2288	VendorInvestigate	2026-Q3	98.78	6.59	—	Buyer-sourced	PASS
AX-2026-041428	QYB	QYB-2604-B4920	Janoshik	2026-Q3	98.35	3.20	—	Laboratory-retained	PASS

Other recent Homopeptide records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042437	Retatrutide	HOMO-2605-V4718	Nordanalyt	2026-Q3	98.68	3.67	102.8	Buyer-sourced	PASS
AX-2026-042424	Semaglutide	HOMO-2604-X3806	PeptideMeter	2026-Q3	98.85	4.87	92.0	Buyer-sourced	PASS
AX-2026-042503	IGF-1 LR3	HOMO-2607-P5131	Janoshik	2026-Q3	99.36	5.99	—	Buyer-sourced	PASS
AX-2026-042492	SS-31 (Elamipretide)	HOMO-2604-D5484	Medutest	2026-Q3	99.93	2.40	—	Buyer-sourced	PASS
AX-2026-042491	SS-31 (Elamipretide)	HOMO-2604-D5484	Kestrel	2026-Q3	99.93	3.24	—	Supplier-supplied	PASS
AX-2026-042473	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.01	5.00	—	Buyer-sourced	PASS
AX-2026-042441	Retatrutide	HOMO-2605-V4718	Medutest	2026-Q3	98.93	4.22	—	Buyer-sourced	PASS
AX-2026-042474	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.18	5.44	—	Buyer-sourced	PASS