AX-2024-004145

Retatrutide · 30 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2408-X2078

PASSPURITY ONLY

Report ID: AX-2024-004145
Compound: Retatrutide
Compound class: Incretin analogues and co-agonists
Supplier: WWB — Wuhan Wansheng Biotechnology Co., Ltd.
Batch / lot: WWB-2408-X2078
Declared label claim: 30mg
Laboratory: Janoshik Analytical
Assay date: 24 Oct 2024
Submitted: 14 Nov 2024
Quarter: 2024-Q4
Submitter: v.palacios
Sample provenance: Buyer-sourced

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	99.73	% area	≥ 96.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.27	% area	≤ 3.5	PASS
Largest single impurity	RP-HPLC — oxidised Trp (+16 Da)	0.12	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	6.18	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	5.74	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.73	%	—	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 with a single visible fibre	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.06	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	20.82	min	20.71 ± 0.50 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.27	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	26,197	—	≥ 20,000	PASS
Resolution to nearest impurity	vs C18 diacid regioisomer	1.10	—	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 26,197, and skew follows the reported asymmetry factor of 1.27. 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 0.12 % impurity against a 99.73 % 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	20.82	4,847,187	99.73	—
2	oxidised Trp (+16 Da)	20.16	5,832	0.12	+15.995
3	truncated (5-39)	18.90	4,374	0.09	-428.201
4	C18 diacid regioisomer	21.40	1,458	0.03	0.000
5	aspartimide (−18 Da)	21.53	1,458	0.03	-18.011
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.

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)	99.78	99.73	divergence +0.44 pp vs batch median
Total impurities (% area)	0.22	0.27
Largest single impurity (% area)	0.09	0.12
Water (%)	not stated	6.18
Counter-ion (%)	5.1	5.74
Peptide content (%w/w)	90.8	not determined
Endotoxin (EU/mg)	1.06	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: Retail purchase → third-party forwarder (16 d) → laboratory (courier, cold pack, 10 d) → assay.
Assay date: 24 Oct 2024
Submitted to the index: 14 Nov 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.
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 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.

aib_coupling14 Nov 2024

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.

hplc_ola14 Nov 2024

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

Section 7

Related records

Same batch — lot WWB-2408-X2078 n=9

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2024-004144	WWB-2408-X2078	VendorInvestigate	2024-Q4	99.57	5.93	105.9	Buyer-sourced	PASS
AX-2024-004146	WWB-2408-X2078	Janoshik	2024-Q4	99.78	5.36	—	Buyer-sourced	PASS
AX-2024-004147	WWB-2408-X2078	PeptideMeter	2024-Q4	99.34	6.02	90.1	Buyer-sourced	PASS
AX-2024-004148	WWB-2408-X2078	Nordanalyt	2024-Q4	99.07	6.44	—	Buyer-sourced	PASS
AX-2024-004149	WWB-2408-X2078	Medutest	2024-Q4	99.02	5.78	—	Buyer-sourced	PASS
AX-2024-004150	WWB-2408-X2078	Janoshik	2024-Q4	99.39	5.78	104.5	Buyer-sourced	PASS
AX-2024-004151	WWB-2408-X2078	Janoshik	2024-Q4	98.85	6.20	—	Buyer-sourced	PASS
AX-2024-004152	WWB-2408-X2078	PeptideMeter	2024-Q4	99.00	5.92	104.9	Buyer-sourced	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 WWB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041275	Liraglutide	WWB-2607-X2189	Nordanalyt	2026-Q3	99.33	4.39	—	Buyer-sourced	1	MARGINAL
AX-2026-041334	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	98.93	4.62	99.9	Buyer-sourced	0	PASS
AX-2026-041337	Semaglutide	WWB-2606-N3192	Nordanalyt	2026-Q3	99.52	3.92	—	Buyer-sourced	0	PASS
AX-2026-041335	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	99.15	4.27	98.9	Buyer-sourced	0	PASS
AX-2026-041271	Liraglutide	WWB-2607-X2189	Medutest	2026-Q3	99.52	4.57	97.4	Buyer-sourced	1	MARGINAL
AX-2026-041328	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	98.99	4.47	106.1	Buyer-sourced	0	PASS
AX-2026-041333	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	99.18	4.51	90.4	Laboratory-retained	0	PASS
AX-2026-041273	Liraglutide	WWB-2607-X2189	Janoshik	2026-Q3	99.31	5.52	104.8	Buyer-sourced	1	MARGINAL