AX-2024-004638 · Exenatide · TFC lot TFC-2409-W5949

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	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.07	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — Trp25 oxidation (+16 Da)	0.05	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	4183.9370	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	4183.9014	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-8.5	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	92.53	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	92.47	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	9.97	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	9.219	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	92.2	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	2.31	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.94	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.22	%	—	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, 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	5.32	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	7.90	min	8.06 ± 0.40 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.11	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	79,664	—	≥ 20,000	PASS
Resolution to nearest impurity	vs des-Gly1 truncate (−57 Da)	1.83	—	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 79,664, and skew follows the reported asymmetry factor of 1.11. 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	Exenatide — main peak	7.90	4,856,908	99.93	—
2	Trp25 oxidation (+16 Da)	7.54	2,430	0.05	+15.995
3	des-Gly1 truncate (−57 Da)	7.69	972	0.02	-57.021
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 3

Mass spectrum and identity

Theoretical monoisotopic mass 4183.9370 Da, computed from C184H282N50O60S. All ppm figures on this site are against monoisotopic values — see why that matters.

Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 4183.9014 Da. Sodium (+21.982/z) and potassium (+37.956/z) adducts are shown where the parent charge state exceeds 25 % relative abundance; they are adducts of the same molecule and are not impurities.

Charge	Theoretical m/z	Observed m/z	Δ m/z	Rel. abundance (%)
6+	698.3301	698.3242	-0.0059	8.1
5+	837.7947	837.7876	-0.0071	51.1
4+	1046.9915	1046.9826	-0.0089	100.0
3+	1395.6529	1395.6411	-0.0118	54.0
2+	2092.9758	2092.9580	-0.0178	8.4

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	2.31
Counter-ion (acetate)	ion chromatography	4.94
Residual solvent + inorganic residue	estimated	0.22
Total peptide content	by difference	92.53
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)	99.90	99.93	divergence +0.07 pp vs batch median
Total impurities (% area)	not stated	0.07
Largest single impurity (% area)	not stated	0.05
Water (%)	not stated	2.31
Counter-ion (%)	not stated	4.94
Peptide content (%w/w)	not stated	92.53
Endotoxin (EU/mg)	not stated	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: Laboratory-retained
Evidentiary weight: Provenance documented, selection uncontrolled.
Chain of custody: Laboratory retained sample (−20 °C, 33 d since original receipt) → re-assay.
Assay date: 27 Nov 2024
Submitted to the index: 18 Dec 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 not a near-isobaric alternative. Identity was confirmed at unit mass resolution, which cannot exclude species differing by 1 or 2 Da. The specific alternatives not excluded are named in the identity block above.
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 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

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 TFC-2409-W5949 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004637	TFC-2409-W5949	Medutest	2024-Q4	99.58	2.22	96.2	Supplier-supplied	0	PASS
AX-2024-004639	TFC-2409-W5949	Janoshik	2024-Q4	99.93	2.57	—	Supplier-supplied	0	PASS
AX-2024-004640	TFC-2409-W5949	PeptideMeter	2024-Q4	99.73	2.47	—	Supplier-supplied	1	MARGINAL
AX-2024-004641	TFC-2409-W5949	Janoshik	2024-Q4	99.63	2.07	95.3	Laboratory-retained	0	PASS
AX-2024-004642	TFC-2409-W5949	Medutest	2024-Q4	99.60	2.26	95.4	Supplier-supplied	0	PASS
AX-2024-004643	TFC-2409-W5949	Janoshik	2024-Q4	99.93	2.34	106.6	Supplier-supplied	0	PASS
AX-2025-019264	TFC-2409-W5949	Janoshik	2024-Q4	99.93	2.01	101.1	Supplier-supplied	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-2026-042500	SWB	SWB-2603-D6146	PeptideMeter	2026-Q3	98.70	5.31	—	Supplier-supplied	2	MARGINAL
AX-2026-041712	QSC	QSC-2602-P9435	Medutest	2026-Q2	99.48	4.78	—	Supplier-supplied	0	PASS
AX-2026-041715	QSC	QSC-2602-P9435	PeptideMeter	2026-Q2	98.94	5.18	—	Supplier-supplied	0	PASS
AX-2026-041716	QSC	QSC-2602-P9435	VendorInvestigate	2026-Q2	98.64	5.35	—	Buyer-sourced	0	PASS
AX-2026-041710	QSC	QSC-2602-P9435	Janoshik	2026-Q2	99.32	4.84	—	Supplier-supplied	0	PASS
AX-2026-041711	QSC	QSC-2602-P9435	Kestrel	2026-Q2	99.26	4.59	—	Supplier-supplied	1	MARGINAL
AX-2026-041714	QSC	QSC-2602-P9435	PeptideMeter	2026-Q2	98.45	5.10	103.4	Supplier-supplied	0	PASS
AX-2026-041713	QSC	QSC-2602-P9435	PeptideMeter	2026-Q2	98.93	5.58	—	Supplier-supplied	1	MARGINAL

Other recent TFC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041932	Semaglutide	TFC-2604-X4301	Janoshik	2026-Q3	98.88	4.31	—	Supplier-supplied	0	PASS
AX-2026-042067	SS-31 (Elamipretide)	TFC-2604-Y7472	Kestrel	2026-Q3	98.66	4.44	—	Supplier-supplied	1	MARGINAL
AX-2026-042057	Sermorelin	TFC-2605-Y6440	Janoshik	2026-Q3	98.68	3.94	98.3	Supplier-supplied	0	PASS
AX-2026-041936	Semaglutide	TFC-2604-X4301	PeptideMeter	2026-Q3	98.62	4.30	—	Buyer-sourced	1	MARGINAL
AX-2026-041973	Humanin (HNG)	TFC-2605-U5564	Janoshik	2026-Q3	99.62	7.03	—	Supplier-supplied	2	FAIL
AX-2026-041980	Humanin (HNG)	TFC-2605-U5564	Janoshik	2026-Q3	99.90	7.01	88.6	Supplier-supplied	2	MARGINAL
AX-2026-041961	Tirzepatide	TFC-2605-G5134	Medutest	2026-Q3	98.25	7.11	—	Supplier-supplied	2	MARGINAL
AX-2026-042068	SS-31 (Elamipretide)	TFC-2604-Y7472	Medutest	2026-Q3	98.71	3.63	92.9	Supplier-supplied	2	MARGINAL