AX-2025-020569

Retatrutide · 30 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2508-N7334

MARGINALPURITY ONLY

Report ID: AX-2025-020569
Compound: Retatrutide
Compound class: Incretin analogues and co-agonists
Supplier: SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Batch / lot: SSA-2508-N7334
Declared label claim: 30mg
Laboratory: Janoshik Analytical
Assay date: 05 Aug 2025
Submitted: 29 Aug 2025
Quarter: 2025-Q3
Submitter: h.weiss
Sample provenance: Supplier-supplied

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	98.27	% area	≥ 96.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.73	% area	≤ 3.5	PASS
Largest single impurity	RP-HPLC — oxidised Trp (+16 Da)	0.85	% 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	87.39	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	85.88	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	35.83	mg	30 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	30.771	mg	30 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	102.6	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.21	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	7.67	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.73	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.87	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	3.10	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	19.41	min	20.71 ± 0.50 (normalised)	FAIL
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.15	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	74,857	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib2]-diastereomer	0.76	—	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 74,857, and skew follows the reported asymmetry factor of 1.15. 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 0.85 % impurity against a 98.27 % 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	19.41	4,776,227	98.27	—
2	oxidised Trp (+16 Da)	18.75	41,313	0.85	+15.995
3	retatrutide dimer	23.53	19,441	0.40	+4728.487
4	des-Aib20 analogue	18.97	11,179	0.23	-85.053
5	C18 diacid regioisomer	19.99	6,804	0.14	0.000
6	incomplete Fmoc removal (+222 Da)	21.82	2,916	0.06	+222.068
7	[D-Aib2]-diastereomer	19.19	2,430	0.05	0.000
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	4.21
Counter-ion (TFA)	ion chromatography	7.67
Residual solvent + inorganic residue	estimated	0.73
Total peptide content	by difference	87.39
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)	97.83	98.27	divergence -0.17 pp vs batch median
Total impurities (% area)	2.17	1.73
Largest single impurity (% area)	1.40	0.85
Water (%)	2.5	4.21
Counter-ion (%)	not stated	7.67
Peptide content (%w/w)	not stated	87.39
Endotoxin (EU/mg)	not stated	0.87
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, 9 d) → assay. Submitter did not handle the vial.
Assay date: 05 Aug 2025
Submitted to the index: 29 Aug 2025
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.

uncertainty_budget29 Aug 2025

Integration boundary on a close pair contributes up to 0.45 pp of standard uncertainty on its own. That is the term to quote alongside 98.27 % rather than a resolution verdict.

baseline_noise29 Aug 2025

Dwell volume differences between instruments shift the effective start of the gradient. On a fast method that is a substantial fraction of the window and it is never on the report.

Section 7

Related records

Same batch — lot SSA-2508-N7334 n=4

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020568	SSA-2508-N7334	Janoshik	2025-Q3	97.87	4.13	98.2	Buyer-sourced	1	MARGINAL
AX-2025-020570	SSA-2508-N7334	Janoshik	2025-Q3	98.12	4.13	—	Buyer-sourced	0	PASS
AX-2025-020571	SSA-2508-N7334	Janoshik	2025-Q3	97.87	4.42	—	Supplier-supplied	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 SSA records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043135	BPC-157	SSA-2601-N6863	Nordanalyt	2026-Q2	98.16	4.66	92.8	Buyer-sourced	1	MARGINAL
AX-2026-043160	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.01	4.02	91.8	Buyer-sourced	0	PASS
AX-2026-043157	GHK-Cu	SSA-2604-V7731	Medutest	2026-Q2	99.19	5.14	—	Supplier-supplied	0	PASS
AX-2026-043141	BPC-157	SSA-2601-N6863	Janoshik	2026-Q2	98.06	4.06	94.6	Buyer-sourced	1	MARGINAL
AX-2026-043154	GHK-Cu	SSA-2604-V7731	PeptideMeter	2026-Q2	97.82	4.82	101.6	Buyer-sourced	0	PASS
AX-2026-043137	BPC-157	SSA-2601-N6863	PeptideMeter	2026-Q2	98.17	4.14	—	Buyer-sourced	1	MARGINAL
AX-2026-043162	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.50	4.36	—	Supplier-supplied	0	PASS
AX-2026-043134	BPC-157	SSA-2601-N6863	Medutest	2026-Q2	97.89	4.01	—	Buyer-sourced	1	FAIL