AX-2025-019587 · Tirzepatide · TFC lot TFC-2508-G1453

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	99.64	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.36	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — des-Gly deletion (−57 Da)	0.21	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	4.09	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	5.81	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.22	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.73	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	3.81	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	20.08	min	19.86 ± 0.45 (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	30,409	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib13]-diastereomer	0.40	—	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 30,409, 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 0.21 % impurity against a 99.64 % 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	20.08	4,842,813	99.64	—
2	des-Gly deletion (−57 Da)	19.47	10,207	0.21	-57.021
3	des-Aib2 analogue	19.73	3,402	0.07	-85.053
4	Met(O) sulfoxide (+16 Da)	19.34	2,430	0.05	+15.995
5	[D-Aib13]-diastereomer	19.89	1,458	0.03	0.000
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.

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)	99.16	99.64	divergence -0.04 pp vs batch median
Total impurities (% area)	not stated	0.36
Largest single impurity (% area)	not stated	0.21
Water (%)	not stated	4.09
Counter-ion (%)	6.5	5.81
Peptide content (%w/w)	89.4	not determined
Endotoxin (EU/mg)	not stated	0.73
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 12 d) → assay. Submitter did not handle the vial.
Assay date: 06 Sep 2025
Submitted to the index: 13 Sep 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.
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 3

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.

baseline_noise13 Sep 2025

Purity at 99.64 % and water at 4.09 %: the two numbers are independent and both are needed. Excellent chromatography on a wet cake still yields less peptide per vial than the label implies.

cleavage_cocktail13 Sep 2025

Alkylation artefacts from a scavenger-poor cleavage would appear as a +58 or +76 family here. Absent, which says the cleavage was run properly.

coa_template13 Sep 2025

Where a supplier-supplied sample arrives with the lot-specific certificate attached, the documentation is usually better than what a retail buyer receives. Two different processes generate them.

Section 7

Related records

Same batch — lot TFC-2508-G1453 n=11

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019578	TFC-2508-G1453	PeptideMeter	2025-Q3	98.74	4.30	93.5	Buyer-sourced	0	PASS
AX-2025-019579	TFC-2508-G1453	Nordanalyt	2025-Q3	98.80	4.43	89.6	Buyer-sourced	1	MARGINAL
AX-2025-019580	TFC-2508-G1453	Janoshik	2025-Q3	99.22	4.40	91.8	Buyer-sourced	0	PASS
AX-2025-019581	TFC-2508-G1453	PeptideMeter	2025-Q3	99.20	4.27	96.4	Buyer-sourced	0	PASS
AX-2025-019582	TFC-2508-G1453	VendorInvestigate	2025-Q3	99.66	4.29	94.8	Buyer-sourced	0	PASS
AX-2025-019583	TFC-2508-G1453	Janoshik	2025-Q3	99.05	3.64	105.9	Buyer-sourced	0	PASS
AX-2025-019584	TFC-2508-G1453	VendorInvestigate	2025-Q3	98.30	3.16	—	Buyer-sourced	0	PASS
AX-2025-019585	TFC-2508-G1453	Janoshik	2025-Q3	99.32	4.31	—	Buyer-sourced	0	PASS
AX-2025-019586	TFC-2508-G1453	Medutest	2025-Q3	98.56	3.91	—	Buyer-sourced	0	PASS
AX-2025-019588	TFC-2508-G1453	PeptideMeter	2025-Q3	99.29	4.32	104.4	Buyer-sourced	0	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 TFC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042265	Humanin (HNG)	TFC-2605-U1300	PeptideMeter	2026-Q3	99.52	6.31	—	Buyer-sourced	0	PASS
AX-2026-042222	SS-31 (Elamipretide)	TFC-2607-R9099	VendorInvestigate	2026-Q3	99.46	5.41	102.6	Buyer-sourced	0	PASS
AX-2026-042236	Humanin (HNG)	TFC-2608-S9940	Nordanalyt	2026-Q3	98.64	1.80	—	Buyer-sourced	0	PASS
AX-2026-042282	Retatrutide	TFC-2608-J1156	Janoshik	2026-Q3	98.54	4.27	—	Buyer-sourced	0	PASS
AX-2026-042226	SS-31 (Elamipretide)	TFC-2607-R9099	Janoshik	2026-Q3	99.62	5.47	—	Buyer-sourced	0	PASS
AX-2026-042217	Semaglutide	TFC-2604-X9037	PeptideMeter	2026-Q3	98.95	4.61	96.9	Buyer-sourced	0	PASS
AX-2026-042339	Sermorelin	TFC-2605-Y2176	Kestrel	2026-Q3	99.93	4.14	—	Supplier-supplied	1	FAIL
AX-2026-042214	Semaglutide	TFC-2604-X9037	Kestrel	2026-Q3	99.87	4.66	103.1	Laboratory-retained	0	PASS