AX-2025-018815

Exenatide · 2 mg declared · Flourishglobal Peptide Biotech (Chengdu) Co., Ltd. · lot FGP-2504-V8032

PASSPURITY ONLY

Report ID: AX-2025-018815
Compound: Exenatide
Compound class: Incretin analogues and co-agonists
Supplier: FGP — Flourishglobal Peptide Biotech (Chengdu) Co., Ltd.
Batch / lot: FGP-2504-V8032
Declared label claim: 2mg
Laboratory: Janoshik Analytical
Assay date: 02 Jun 2025
Submitted: 24 Jun 2025
Quarter: 2025-Q2
Submitter: re.sobczak
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	98.68	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.32	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — C-terminal free acid (+1 Da)	0.82	% 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	89.52	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.34	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.12	mg	2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	1.873	mg	2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	93.7	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.54	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.57	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.37	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.20	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 cake, partial shrinkage from vial wall	—	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	4.29	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	14.99	min	14.92 ± 0.40 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.21	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	48,544	—	≥ 20,000	PASS
Resolution to nearest impurity	vs C-terminal free acid (+1 Da)	1.22	—	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 48,544, and skew follows the reported asymmetry factor of 1.21. 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 0.82 % impurity against a 98.68 % 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	Exenatide — main peak	14.99	4,796,154	98.68	—
2	C-terminal free acid (+1 Da)	15.33	39,855	0.82	+0.984
3	Met14 sulfoxide (+16 Da)	14.11	11,179	0.23	+15.995
4	truncated (1-38)	14.44	8,749	0.18	-156.101
5	des-Gly1 truncate (−57 Da)	14.57	2,430	0.05	-57.021
6	Trp25 oxidation (+16 Da)	14.28	1,944	0.04	+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.

Component	Determination	%w/w of cake
Water	Karl Fischer	4.54
Counter-ion (acetate)	ion chromatography	5.57
Residual solvent + inorganic residue	estimated	0.37
Total peptide content	by difference	89.52
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)	99.0	98.68	divergence +0.03 pp vs batch median
Total impurities (% area)	1.00	1.32
Largest single impurity (% area)	not stated	0.82
Water (%)	3.6	4.54
Counter-ion (%)	not stated	5.57
Peptide content (%w/w)	not stated	89.52
Endotoxin (EU/mg)	0.29	0.20
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 (ambient, 17 d) → laboratory (courier, cold pack, 7 d) → assay.
Assay date: 02 Jun 2025
Submitted to the index: 24 Jun 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 1

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.

valley_drop24 Jun 2025

Valley height relative to the smaller peak is the practical criterion an operator uses, and it is not on the report. Resolution is a proxy for it and an imperfect one on asymmetric pairs.

Section 7

Related records

Same batch — lot FGP-2504-V8032 n=12

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-018804	FGP-2504-V8032	Janoshik	2025-Q2	98.40	3.81	98.7	Buyer-sourced	0	PASS
AX-2025-018805	FGP-2504-V8032	Janoshik	2025-Q2	99.10	4.18	106.7	Laboratory-retained	0	PASS
AX-2025-018806	FGP-2504-V8032	VendorInvestigate	2025-Q2	98.52	3.76	105.3	Buyer-sourced	0	PASS
AX-2025-018807	FGP-2504-V8032	Janoshik	2025-Q2	98.88	4.58	—	Buyer-sourced	0	PASS
AX-2025-018808	FGP-2504-V8032	VendorInvestigate	2025-Q2	98.96	4.09	—	Buyer-sourced	1	MARGINAL
AX-2025-018809	FGP-2504-V8032	Medutest	2025-Q2	98.99	4.03	93.7	Laboratory-retained	1	MARGINAL
AX-2025-018810	FGP-2504-V8032	Medutest	2025-Q2	99.27	3.97	97.7	Buyer-sourced	0	PASS
AX-2025-018811	FGP-2504-V8032	Janoshik	2025-Q2	98.98	4.32	90.6	Buyer-sourced	0	PASS
AX-2025-018812	FGP-2504-V8032	Medutest	2025-Q2	99.10	3.89	88.9	Buyer-sourced	1	MARGINAL
AX-2025-018813	FGP-2504-V8032	PeptideMeter	2025-Q2	99.07	4.02	—	Buyer-sourced	0	PASS
AX-2025-018814	FGP-2504-V8032	PeptideMeter	2025-Q2	98.43	3.69	—	Buyer-sourced	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Exenatide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041808	ASY	ASY-{CAT}-2827	Janoshik	2026-Q2	99.32	4.59	95.7	Buyer-sourced	0	PASS
AX-2026-041803	ASY	ASY-{CAT}-2827	Medutest	2026-Q2	99.61	4.99	—	Buyer-sourced	0	PASS
AX-2026-041804	ASY	ASY-{CAT}-2827	VendorInvestigate	2026-Q2	99.12	4.76	98.0	Buyer-sourced	0	PASS
AX-2026-041802	ASY	ASY-{CAT}-2827	Janoshik	2026-Q2	99.44	4.12	106.6	Buyer-sourced	0	PASS
AX-2026-041810	ASY	ASY-{CAT}-2827	VendorInvestigate	2026-Q2	99.23	4.33	—	Laboratory-retained	0	PASS
AX-2026-041809	ASY	ASY-{CAT}-2827	Nordanalyt	2026-Q2	99.70	4.39	98.7	Buyer-sourced	1	MARGINAL
AX-2026-041811	ASY	ASY-{CAT}-2827	Janoshik	2026-Q2	99.29	4.64	—	Buyer-sourced	0	PASS
AX-2026-041801	ASY	ASY-{CAT}-2827	Nordanalyt	2026-Q2	99.34	4.76	—	Buyer-sourced	1	MARGINAL

Other recent FGP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-041643	Semaglutide	FGP-2602-M8547	Janoshik	2026-Q3	99.31	2.79	100.7	Buyer-sourced	PASS
AX-2026-041638	Semaglutide	FGP-2602-M8547	Janoshik	2026-Q3	99.40	2.75	105.8	Buyer-sourced	PASS
AX-2026-041641	Semaglutide	FGP-2602-M8547	PeptideMeter	2026-Q3	98.98	2.38	105.0	Buyer-sourced	PASS
AX-2026-041610	Tirzepatide	FGP-2603-L7753	Janoshik	2026-Q3	98.81	2.45	101.0	Buyer-sourced	PASS
AX-2026-041637	Semaglutide	FGP-2602-M8547	PeptideMeter	2026-Q3	99.40	2.83	—	Laboratory-retained	PASS
AX-2026-041642	Semaglutide	FGP-2602-M8547	PeptideMeter	2026-Q3	98.78	2.24	—	Buyer-sourced	PASS
AX-2026-041609	Tirzepatide	FGP-2603-L7753	Janoshik	2026-Q3	98.52	2.00	98.0	Buyer-sourced	PASS
AX-2026-041636	Semaglutide	FGP-2602-M8547	Nordanalyt	2026-Q3	99.39	2.17	—	Buyer-sourced	PASS