AX-2024-005392

Retatrutide · 12 mg declared · PolyPeptide Group (Hangzhou) Co., Ltd. · lot PPG-2311-F8058

PASSMETHOD LIMITED

Report ID: AX-2024-005392
Compound: Retatrutide
Compound class: Incretin analogues and co-agonists
Supplier: PPG — PolyPeptide Group (Hangzhou) Co., Ltd.
Batch / lot: PPG-2311-F8058
Declared label claim: 12mg
Laboratory: Kestrel Bioanalytical
Assay date: 16 Jun 2024
Submitted: 24 Jun 2024
Quarter: 2024-Q2
Submitter: v.tulloch
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, 15 min gradient, 214 nm	99.93	% area	≥ 96.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.07	% area	≤ 3.5	PASS
Largest single impurity	RP-HPLC — des-Aib20 analogue	0.05	% 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	4.35	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	9.26	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.28	%	—	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 cake, partially collapsed	—	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	3.63	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	11.18	min	11.18 ± 0.50 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.38	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	54,905	—	≥ 20,000	PASS
Resolution to nearest impurity	vs des-Aib20 analogue	1.12	—	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, 15 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 54,905, and skew follows the reported asymmetry factor of 1.38. 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 0.05 % 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	Retatrutide — main peak	11.18	4,856,908	99.93	—
2	des-Aib20 analogue	10.96	2,430	0.05	-85.053
3	oxidised Trp (+16 Da)	10.85	972	0.02	+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 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)	99.02	99.93	divergence +0.26 pp vs batch median
Total impurities (% area)	0.98	0.07
Largest single impurity (% area)	0.52	0.05
Water (%)	3.6	4.35
Counter-ion (%)	5.4	9.26
Peptide content (%w/w)	90.4	not determined
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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Retail purchase → submitter (2–8 °C, 2 d) → laboratory (courier, ambient, 6 d) → assay.
Assay date: 16 Jun 2024
Submitted to the index: 24 Jun 2024
Laboratory: Kestrel Bioanalytical, Melbourne, Australia
Method basis: 15 min gradient · unit-resolution MS
Verification status: METHOD LIMITED

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 mass-identical impurities are absent. The gradient used is shorter than the index reference method and does not resolve the diastereomers named in the compound fingerprint. The purity figure is an upper bound.
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.

plate_count24 Jun 2024

Where the plate count is low the resolution figure is low for a reason that has nothing to do with the impurity profile. Read the two together or read neither.

lal_assay24 Jun 2024

Recombinant factor C would sidestep the reagent supply constraint entirely and correlates well. Nothing in this market uses it.

Section 7

Related records

Same batch — lot PPG-2311-F8058 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005385	PPG-2311-F8058	Janoshik	2024-Q2	98.87	4.97	—	Buyer-sourced	0	PASS
AX-2024-005386	PPG-2311-F8058	PeptideMeter	2024-Q2	98.39	4.21	90.8	Buyer-sourced	0	PASS
AX-2024-005387	PPG-2311-F8058	Janoshik	2024-Q2	98.84	4.25	—	Buyer-sourced	0	PASS
AX-2024-005388	PPG-2311-F8058	Medutest	2024-Q2	98.65	3.82	95.5	Buyer-sourced	1	FAIL
AX-2024-005389	PPG-2311-F8058	PeptideMeter	2024-Q2	98.79	4.76	—	Buyer-sourced	0	PASS
AX-2024-005390	PPG-2311-F8058	Janoshik	2024-Q2	98.72	4.05	95.1	Buyer-sourced	0	PASS
AX-2024-005391	PPG-2311-F8058	Janoshik	2024-Q2	98.71	4.19	—	Buyer-sourced	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 PPG records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043598	Tesamorelin	PPG-2608-A6835	Kestrel	2026-Q3	98.91	2.56	100.3	Buyer-sourced	1	FAIL
AX-2026-043597	Tesamorelin	PPG-2608-A6835	Janoshik	2026-Q3	98.54	1.15	—	Buyer-sourced	0	PASS
AX-2026-043596	Tesamorelin	PPG-2608-A6835	PeptideMeter	2026-Q3	98.74	1.83	105.1	Buyer-sourced	1	MARGINAL
AX-2026-043605	Retatrutide	PPG-2604-X7060	Janoshik	2026-Q2	98.17	4.29	99.7	Buyer-sourced	0	PASS
AX-2026-043601	Retatrutide	PPG-2604-X7060	Janoshik	2026-Q2	98.28	3.96	95.3	Buyer-sourced	0	PASS
AX-2026-043668	AOD-9604	PPG-2602-W8018	PeptideMeter	2026-Q2	99.47	3.06	—	Buyer-sourced	0	PASS
AX-2026-043670	AOD-9604	PPG-2602-W8018	PeptideMeter	2026-Q2	99.56	2.71	104.5	Buyer-sourced	0	PASS
AX-2026-043630	CJC-1295 (no DAC)	PPG-2512-D7211	Janoshik	2026-Q2	99.66	5.11	92.5	Buyer-sourced	0	PASS