AX-2025-019349 · Tirzepatide · HYB lot HYB-2408-W6301

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	99.10	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.90	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — [D-Aib13]-diastereomer	0.53	% 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)	4810.2949	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-24.0	ppm	± 15	FAIL
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	3.88	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	9.66	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.82	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.93	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	3.05	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	16.84	min	16.81 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.13	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	42,027	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib13]-diastereomer	0.47	—	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 42,027, and skew follows the reported asymmetry factor of 1.13. 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 0.53 % impurity against a 99.10 % 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	16.84	4,816,567	99.10	—
2	[D-Aib13]-diastereomer	16.68	25,760	0.53	0.000
3	C20 diacid mono-amide	18.19	9,721	0.20	+0.984
4	Met(O) sulfoxide (+16 Da)	16.22	3,402	0.07	+15.995
5	des-Gly deletion (−57 Da)	16.33	2,916	0.06	-57.021
6	des-Aib2 analogue	16.55	1,944	0.04	-85.053
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 4810.2949 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	688.1923	-0.0164	8.0
6+	802.7423	802.7231	-0.0192	55.3
5+	963.0893	963.0663	-0.0230	100.0
4+	1203.6099	1203.5810	-0.0289	52.0
3+	1604.4774	1604.4389	-0.0385	8.6

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)	101.0	99.10	divergence +1.99 pp vs batch median
Total impurities (% area)	not stated	0.90
Largest single impurity (% area)	not stated	0.53
Water (%)	4.0	3.88
Counter-ion (%)	3.7	9.66
Peptide content (%w/w)	91.7	not determined
Endotoxin (EU/mg)	0.71	0.93
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 → third-party forwarder (32 d) → laboratory (courier, cold pack, 8 d) → assay.
Assay date: 26 Feb 2025
Submitted to the index: 20 Mar 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 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 4

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.

ms_confirm20 Mar 2025

Identity confirmation needs a reference standard and the record does not say whose was used. Where the deviation is small this is the first ambiguity to remove.

digit_preference20 Mar 2025

Rule AX-R04 fires on the pattern rather than on this record, which is the right design: one round figure is a coincidence and three is a template. The underlying chromatograms exist and are supplied on request.

one_directional20 Mar 2025

Stacking every explainable source pessimistically — inter-lab agreement, gradient length, within-lot vial variation — accounts for about 1.2 pp. This gap is larger, which is what makes it a document question rather than a measurement question.

thin_coverage20 Mar 2025

The rule has fired on well under one per cent of the index. That rate is the context for reading any individual instance, and it is on the rule page.

Section 7

Related records

Same batch — lot HYB-2408-W6301 n=5

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019346	HYB-2408-W6301	Janoshik	2025-Q1	99.01	4.38	99.3	Buyer-sourced	2	MARGINAL
AX-2025-019347	HYB-2408-W6301	PeptideMeter	2025-Q1	99.12	3.95	—	Buyer-sourced	2	MARGINAL
AX-2025-019348	HYB-2408-W6301	PeptideMeter	2025-Q1	98.78	4.18	96.6	Buyer-sourced	2	MARGINAL
AX-2025-019350	HYB-2408-W6301	VendorInvestigate	2025-Q1	97.96	4.27	105.7	Buyer-sourced	2	MARGINAL

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 HYB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042083	MOTS-c	HYB-2606-D7858	Medutest	2026-Q3	99.93	2.02	—	Buyer-sourced	0	PASS
AX-2026-042090	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.57	2.36	—	Buyer-sourced	1	FAIL
AX-2026-042084	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.28	2.79	107.3	Buyer-sourced	0	PASS
AX-2026-042087	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.54	3.05	—	Buyer-sourced	0	PASS
AX-2026-042085	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.51	2.31	—	Buyer-sourced	0	PASS
AX-2026-042088	MOTS-c	HYB-2606-D7858	PeptideMeter	2026-Q3	99.22	2.21	—	Buyer-sourced	0	PASS
AX-2026-042086	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.93	3.02	—	Buyer-sourced	1	MARGINAL
AX-2026-042091	CJC-1295 with DAC	HYB-2608-E7391	Janoshik	2026-Q3	99.38	5.53	—	Buyer-sourced	0	PASS