AX-2025-020914 · Pemvidutide · CPC lot CPC-2507-H2201

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	98.41	% area	≥ 96.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.59	% area	≤ 4.0	PASS
Largest single impurity	RP-HPLC — [D-Aib2]-diastereomer	1.01	% area	≤ 1.00	FAIL
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	85.53	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	84.17	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.07	mg	1.8 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	1.742	mg	1.8 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	96.8	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.35	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	9.31	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.81	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
Sterility	membrane filtration, USP <71>, 14 d	No growth at 14 d	—	no growth	PASS
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 after 90 s gentle swirling, no particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	2.68	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	11.09	min	10.99 ± 0.50 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.35	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	65,837	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib2]-diastereomer	0.56	—	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 65,837, and skew follows the reported asymmetry factor of 1.35. 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 1.01 % impurity against a 98.41 % 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	11.09	4,783,031	98.41	—
2	[D-Aib2]-diastereomer	10.99	49,089	1.01	0.000
3	des-EDA linker (−60 Da)	10.65	13,609	0.28	-60.048
4	aspartimide (−18 Da)	11.38	8,263	0.17	-18.011
5	truncated (3-39)	10.31	6,318	0.13	-222.112
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	4.35
Counter-ion (TFA)	ion chromatography	9.31
Residual solvent + inorganic residue	estimated	0.81
Total peptide content	by difference	85.53
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)	98.0	98.41	divergence -0.35 pp vs batch median
Total impurities (% area)	1.39	1.59
Largest single impurity (% area)	0.64	1.01
Water (%)	3.6	4.35
Counter-ion (%)	not stated	9.31
Peptide content (%w/w)	not stated	85.53
Endotoxin (EU/mg)	0.70	not determined
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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Retail purchase → submitter (ambient, 11 d) → laboratory (courier, cold pack, 9 d) → assay.
Assay date: 29 Nov 2025
Submitted to the index: 24 Dec 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 free of bacterial endotoxin. Endotoxin was not measured. No chromatographic result bears on it.
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

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot CPC-2507-H2201 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020913	CPC-2507-H2201	Janoshik	2025-Q4	97.93	4.02	90.7	Buyer-sourced	3	MARGINAL
AX-2025-020915	CPC-2507-H2201	Nordanalyt	2025-Q4	98.51	3.52	—	Supplier-supplied	3	MARGINAL
AX-2025-020916	CPC-2507-H2201	Medutest	2025-Q4	98.66	3.85	—	Supplier-supplied	3	MARGINAL
AX-2025-020917	CPC-2507-H2201	PeptideMeter	2025-Q4	98.29	3.78	—	Supplier-supplied	3	MARGINAL
AX-2025-020918	CPC-2507-H2201	Janoshik	2025-Q4	98.17	3.53	103.8	Supplier-supplied	3	MARGINAL
AX-2025-020919	CPC-2507-H2201	VendorInvestigate	2025-Q4	97.85	4.31	102.6	Buyer-sourced	4	MARGINAL
AX-2025-020920	CPC-2507-H2201	PeptideMeter	2025-Q4	98.81	4.43	97.0	Supplier-supplied	3	MARGINAL

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-2025-020916	CPC	CPC-2507-H2201	Medutest	2025-Q4	98.66	3.85	—	Supplier-supplied	3	MARGINAL
AX-2025-020920	CPC	CPC-2507-H2201	PeptideMeter	2025-Q4	98.81	4.43	97.0	Supplier-supplied	3	MARGINAL
AX-2025-020918	CPC	CPC-2507-H2201	Janoshik	2025-Q4	98.17	3.53	103.8	Supplier-supplied	3	MARGINAL
AX-2025-020917	CPC	CPC-2507-H2201	PeptideMeter	2025-Q4	98.29	3.78	—	Supplier-supplied	3	MARGINAL
AX-2025-020919	CPC	CPC-2507-H2201	VendorInvestigate	2025-Q4	97.85	4.31	102.6	Buyer-sourced	4	MARGINAL
AX-2025-020913	CPC	CPC-2507-H2201	Janoshik	2025-Q4	97.93	4.02	90.7	Buyer-sourced	3	MARGINAL
AX-2025-020915	CPC	CPC-2507-H2201	Nordanalyt	2025-Q4	98.51	3.52	—	Supplier-supplied	3	MARGINAL
AX-2025-018613	QYB	QYB-2502-V5083	Nordanalyt	2025-Q3	98.10	4.15	—	Supplier-supplied	3	MARGINAL

Other recent CPC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043368	N-Acetyl Semax Amide	CPC-2602-D2941	Medutest	2026-Q3	98.79	6.05	102.1	Supplier-supplied	0	PASS
AX-2026-043335	Liraglutide	CPC-2602-G1978	Janoshik	2026-Q3	97.29	4.91	—	Laboratory-retained	1	FAIL
AX-2026-043283	L-Carnosine	CPC-2603-G1651	Medutest	2026-Q3	98.10	10.12	91.8	Supplier-supplied	1	FAIL
AX-2026-043365	BPC-157	CPC-2602-W2646	Medutest	2026-Q3	98.56	2.80	—	Supplier-supplied	1	MARGINAL
AX-2026-043332	Liraglutide	CPC-2602-G1978	Janoshik	2026-Q3	97.16	4.88	91.3	Supplier-supplied	1	FAIL
AX-2026-043289	L-Carnosine	CPC-2603-G1651	Janoshik	2026-Q3	98.01	10.52	—	Buyer-sourced	1	FAIL
AX-2026-043287	L-Carnosine	CPC-2603-G1651	Janoshik	2026-Q3	98.35	9.89	93.2	Supplier-supplied	2	FAIL
AX-2026-043367	N-Acetyl Semax Amide	CPC-2602-D2941	Nordanalyt	2026-Q3	99.39	6.16	92.4	Supplier-supplied	0	PASS