AX-2025-018462 · Tirzepatide · WWB lot WWB-2506-T2732

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, 25 min gradient, 214 nm	99.30	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.70	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — des-Aib2 analogue	0.48	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	4810.4103	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	4810.3761	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-7.1	ppm	± 15	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	3.92	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	5.73	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.41	%	—	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	3.51	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	16.85	min	16.81 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.18	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	52,270	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib13]-diastereomer	0.52	—	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, 25 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 52,270, and skew follows the reported asymmetry factor of 1.18. 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 0.48 % impurity against a 99.30 % 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	Tirzepatide — main peak	16.85	4,826,288	99.30	—
2	des-Aib2 analogue	16.56	23,329	0.48	-85.053
3	truncated (3-39)	15.62	5,832	0.12	-222.112
4	[D-Aib13]-diastereomer	16.69	2,916	0.06	0.000
5	Met(O) sulfoxide (+16 Da)	16.23	972	0.02	+15.995
6	trifluoroacetyl adduct (+96 Da)	17.63	972	0.02	+95.982
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 4810.4103 Da, computed from C225H348N48O68. 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 4810.3761 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 (%)
7+	688.2087	688.2039	-0.0048	7.7
6+	802.7423	802.7366	-0.0057	54.7
5+	963.0893	963.0825	-0.0068	100.0
4+	1203.6099	1203.6013	-0.0086	56.4
3+	1604.4774	1604.4660	-0.0114	7.7

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)	98.60	99.30	divergence -0.53 pp vs batch median
Total impurities (% area)	1.40	0.70
Largest single impurity (% area)	0.77	0.48
Water (%)	2.8	3.92
Counter-ion (%)	not stated	5.73
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	0.24	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: Domestic warehouse despatch → submitter (2–8 °C, 21 d) → laboratory (courier, cold pack, 3 d) → assay.
Assay date: 14 Oct 2025
Submitted to the index: 29 Oct 2025
Laboratory: Medutest, Ljubljana, Slovenia
Method basis: 25 min gradient · unit-resolution MS
Verification status: IDENTITY CONSISTENT

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.
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.

lambda_21429 Oct 2025

At 214 nm the amide bond dominates the response, so a peptide impurity is seen roughly in proportion to its size. 99.30 % on this detection is the conservative reading; a 280 nm trace would flatter it.

storage_stated29 Oct 2025

A retail vial at 99.30 % is worth more evidentially than a selected vial at a higher figure. That is the whole argument for recording provenance at all.

Section 7

Related records

Same batch — lot WWB-2506-T2732 n=10

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2025-018459	WWB-2506-T2732	PeptideMeter	2025-Q4	99.10	3.44	—	Buyer-sourced	PASS
AX-2025-018460	WWB-2506-T2732	Kestrel	2025-Q4	99.73	3.33	95.6	Buyer-sourced	PASS
AX-2025-018461	WWB-2506-T2732	VendorInvestigate	2025-Q4	98.74	4.23	95.8	Buyer-sourced	PASS
AX-2025-018463	WWB-2506-T2732	Janoshik	2025-Q4	99.29	3.87	90.2	Buyer-sourced	PASS
AX-2026-041277	WWB-2506-T2732	Nordanalyt	2025-Q4	99.10	4.05	107.3	Laboratory-retained	PASS
AX-2026-041278	WWB-2506-T2732	Janoshik	2025-Q4	99.14	4.41	93.3	Buyer-sourced	PASS
AX-2025-018464	WWB-2506-T2732	Janoshik	2025-Q4	99.08	3.36	106.7	Buyer-sourced	PASS
AX-2025-018465	WWB-2506-T2732	PeptideMeter	2025-Q4	99.12	3.71	—	Buyer-sourced	PASS
AX-2025-018466	WWB-2506-T2732	PeptideMeter	2025-Q4	99.27	3.73	—	Buyer-sourced	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Tirzepatide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-043288	CPC	CPC-2607-L1516	Janoshik	2026-Q3	96.89	5.11	101.1	Laboratory-retained	FAIL
AX-2026-041610	FGP	FGP-2603-L7753	Janoshik	2026-Q3	98.81	2.45	101.0	Buyer-sourced	PASS
AX-2026-041974	AMB	AMB-2603-C5112	Nordanalyt	2026-Q3	98.20	3.41	—	Buyer-sourced	PASS
AX-2026-041975	AMB	AMB-2603-C5112	Medutest	2026-Q3	97.88	3.45	106.9	Laboratory-retained	PASS
AX-2026-041609	FGP	FGP-2603-L7753	Janoshik	2026-Q3	98.52	2.00	98.0	Buyer-sourced	PASS
AX-2026-041978	AMB	AMB-2603-C5112	Janoshik	2026-Q3	97.94	3.57	103.0	Buyer-sourced	PASS
AX-2026-041982	AMB	AMB-2603-C5112	Janoshik	2026-Q3	97.60	4.46	—	Buyer-sourced	PASS
AX-2026-043286	CPC	CPC-2607-L1516	Kestrel	2026-Q3	98.20	4.56	—	Buyer-sourced	PASS

Other recent WWB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041275	Liraglutide	WWB-2607-X2189	Nordanalyt	2026-Q3	99.33	4.39	—	Buyer-sourced	1	MARGINAL
AX-2026-041334	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	98.93	4.62	99.9	Buyer-sourced	0	PASS
AX-2026-041337	Semaglutide	WWB-2606-N3192	Nordanalyt	2026-Q3	99.52	3.92	—	Buyer-sourced	0	PASS
AX-2026-041335	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	99.15	4.27	98.9	Buyer-sourced	0	PASS
AX-2026-041271	Liraglutide	WWB-2607-X2189	Medutest	2026-Q3	99.52	4.57	97.4	Buyer-sourced	1	MARGINAL
AX-2026-041328	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	98.99	4.47	106.1	Buyer-sourced	0	PASS
AX-2026-041333	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	99.18	4.51	90.4	Laboratory-retained	0	PASS
AX-2026-041273	Liraglutide	WWB-2607-X2189	Janoshik	2026-Q3	99.31	5.52	104.8	Buyer-sourced	1	MARGINAL