AX-2025-020132

Pemvidutide · 1.2 mg declared · Shanghai ERP Biotechnology Co., Ltd. · lot ERP-2408-G8748

PASSMETHOD LIMITED

Report ID: AX-2025-020132
Compound: Pemvidutide
Compound class: Incretin analogues and co-agonists
Supplier: ERP — Shanghai ERP Biotechnology Co., Ltd.
Batch / lot: ERP-2408-G8748
Declared label claim: 1mg
Laboratory: Kestrel Bioanalytical
Assay date: 08 Mar 2025
Submitted: 15 Mar 2025
Quarter: 2025-Q1
Submitter: k.petrescu
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	99.66	% area	≥ 96.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.34	% area	≤ 4.0	PASS
Largest single impurity	RP-HPLC — truncated (3-39)	0.24	% 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	85.67	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	85.38	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	1.41	mg	1.2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	1.204	mg	1.2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	100.3	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.65	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	9.44	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.24	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.39	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	4.13	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	10.97	min	10.99 ± 0.50 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.14	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	41,403	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib2]-diastereomer	0.45	—	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 41,403, and skew follows the reported asymmetry factor of 1.14. 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 0.24 % impurity against a 99.66 % 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	Pemvidutide — main peak	10.97	4,843,785	99.66	—
2	truncated (3-39)	10.20	11,665	0.24	-222.112
3	des-EDA linker (−60 Da)	10.53	3,402	0.07	-60.048
4	aspartimide (−18 Da)	11.26	972	0.02	-18.011
5	[D-Aib2]-diastereomer	10.87	486	0.01	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	4.65
Counter-ion (TFA)	ion chromatography	9.44
Residual solvent + inorganic residue	estimated	0.24
Total peptide content	by difference	85.67
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)	99.90	99.66	divergence +0.24 pp vs batch median
Total impurities (% area)	not stated	0.34
Largest single impurity (% area)	not stated	0.24
Water (%)	3.4	4.65
Counter-ion (%)	6.7	9.44
Peptide content (%w/w)	89.3	85.67
Endotoxin (EU/mg)	not stated	0.39
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: Domestic warehouse despatch → submitter (2–8 °C, 27 d) → laboratory (courier, cold pack, 10 d) → assay.
Assay date: 08 Mar 2025
Submitted to the index: 15 Mar 2025
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.
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.

buyer_sourced15 Mar 2025

Buyer-sourced through an ordinary retail order, so the supplier had no opportunity to select the vial. This is the provenance class the index weights and it is roughly 87 % of the dataset.

valley_drop15 Mar 2025

The reported figure derives from the plate count and the retention gap, via the pharmacopoeial form with the sum of both peak widths in the denominator. It is a calculated quantity, not a measured one, and it inherits the plate count's uncertainty.

Section 7

Related records

Same batch — lot ERP-2408-G8748 n=1

This is the only report on this lot. One report is not a batch characterisation.

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Pemvidutide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020820	CPC	CPC-2507-H1165	Kestrel	2025-Q4	98.17	4.36	—	Buyer-sourced	0	PASS
AX-2025-020818	CPC	CPC-2507-H1165	Medutest	2025-Q4	98.10	3.84	—	Buyer-sourced	0	PASS
AX-2025-020819	CPC	CPC-2507-H1165	PeptideMeter	2025-Q4	97.90	3.89	101.6	Supplier-supplied	0	PASS
AX-2025-021092	BCH	BCH-2506-G4536	Janoshik	2025-Q3	97.97	5.58	—	Supplier-supplied	0	PASS
AX-2025-018548	QYB	QYB-2502-V4343	Janoshik	2025-Q3	98.81	3.70	107.3	Buyer-sourced	0	PASS
AX-2025-018547	QYB	QYB-2502-V4343	PeptideMeter	2025-Q3	98.66	4.36	91.0	Buyer-sourced	0	PASS
AX-2025-020505	KP	KP-2501-G6332	Medutest	2025-Q1	98.34	5.44	97.0	Buyer-sourced	1	MARGINAL

Other recent ERP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042706	Survodutide	ERP-2605-E9865	PeptideMeter	2026-Q3	98.38	5.33	103.5	Buyer-sourced	0	PASS
AX-2026-042704	Tesamorelin	ERP-2604-W9463	Janoshik	2026-Q3	99.02	4.08	—	Buyer-sourced	1	MARGINAL
AX-2026-042705	Survodutide	ERP-2605-E9865	Janoshik	2026-Q3	98.24	5.36	92.3	Buyer-sourced	0	PASS
AX-2026-042708	GHK-Cu	ERP-2601-F9816	Nordanalyt	2026-Q2	98.88	3.87	91.5	Buyer-sourced	1	MARGINAL
AX-2026-042694	Liraglutide	ERP-2601-P8985	Kestrel	2026-Q2	99.25	4.35	107.3	Buyer-sourced	1	MARGINAL
AX-2026-042707	GHK-Cu	ERP-2601-F9816	Janoshik	2026-Q2	98.53	4.70	96.3	Buyer-sourced	1	MARGINAL
AX-2026-042711	GHK-Cu	ERP-2601-F9816	Kestrel	2026-Q2	98.53	3.84	89.7	Laboratory-retained	2	MARGINAL
AX-2026-042722	Tirzepatide	ERP-2512-T9616	Medutest	2026-Q2	99.18	2.07	—	Buyer-sourced	1	MARGINAL