AX-2025-020583 · Tirzepatide · SSA lot SSA-2502-D7226

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	99.04	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.96	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — truncated (3-39)	0.38	% 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)	4810.4141	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+0.8	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	83.55	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	82.75	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	6.34	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	5.246	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	104.9	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	7.10	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	8.46	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.89	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
Sterility	membrane filtration, USP <71>, 14 d	No growth at 14 d	—	no growth	PASS
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	3.83	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	10.76	min	10.72 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.24	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	59,554	—	≥ 20,000	PASS
Resolution to nearest impurity	vs des-Aib2 analogue	0.97	—	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 59,554, and skew follows the reported asymmetry factor of 1.24. 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 0.38 % impurity against a 99.04 % 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	10.76	4,813,651	99.04	—
2	truncated (3-39)	10.02	18,469	0.38	-222.112
3	Met(O) sulfoxide (+16 Da)	10.39	16,039	0.33	+15.995
4	des-Gly deletion (−57 Da)	10.46	5,346	0.11	-57.021
5	des-Aib2 analogue	10.58	3,402	0.07	-85.053
6	tirzepatide dimer	12.75	3,402	0.07	+4810.410
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 4810.4141 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	688.2093	0.0006	8.3
6+	802.7423	802.7430	0.0007	56.1
5+	963.0893	963.0901	0.0008	100.0
4+	1203.6099	1203.6108	0.0009	54.8
3+	1604.4774	1604.4786	0.0012	9.4

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	7.10
Counter-ion (TFA)	ion chromatography	8.46
Residual solvent + inorganic residue	estimated	0.89
Total peptide content	by difference	83.55
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)	97.5	99.04	divergence -0.44 pp vs batch median
Total impurities (% area)	2.50	0.96
Largest single impurity (% area)	not stated	0.38
Water (%)	4.6	7.10
Counter-ion (%)	not stated	8.46
Peptide content (%w/w)	90.6	83.55
Endotoxin (EU/mg)	not stated	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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 11 d) → assay. Submitter did not handle the vial.
Assay date: 18 Jul 2025
Submitted to the index: 21 Jul 2025
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 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.

tbu_residual21 Jul 2025

No +56 Da satellite in the envelope, which is the residual-protection signature. Its absence is worth as much as the parent mass being right.

area_percent21 Jul 2025

A rounded purity and an unrounded impurity total on the same certificate will not sum to 100 exactly, and that is a rounding artefact rather than the arithmetic failure rule AX-R02 looks for. The slack allowance exists for it.

coa_reader21 Jul 2025

The index publishes the declared figure and the measured figure side by side and does not adjudicate between them. Both are on this page and the difference is stated rather than characterised.

Section 7

Related records

Same batch — lot SSA-2502-D7226 n=13

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020572	SSA-2502-D7226	Medutest	2025-Q3	98.55	6.24	—	Buyer-sourced	1	MARGINAL
AX-2025-020573	SSA-2502-D7226	Janoshik	2025-Q3	97.89	6.94	—	Buyer-sourced	1	MARGINAL
AX-2025-020574	SSA-2502-D7226	Nordanalyt	2025-Q3	98.05	6.69	—	Buyer-sourced	1	MARGINAL
AX-2025-020575	SSA-2502-D7226	VendorInvestigate	2025-Q3	97.94	6.51	—	Buyer-sourced	2	FAIL
AX-2025-020576	SSA-2502-D7226	Nordanalyt	2025-Q3	97.20	7.21	95.0	Buyer-sourced	1	MARGINAL
AX-2025-020577	SSA-2502-D7226	Janoshik	2025-Q3	98.09	6.21	—	Buyer-sourced	1	MARGINAL
AX-2025-020578	SSA-2502-D7226	Janoshik	2025-Q3	97.84	7.06	92.1	Buyer-sourced	1	MARGINAL
AX-2025-020579	SSA-2502-D7226	Medutest	2025-Q3	97.88	6.67	89.7	Buyer-sourced	2	MARGINAL
AX-2025-020580	SSA-2502-D7226	PeptideMeter	2025-Q3	98.05	6.90	—	Laboratory-retained	1	MARGINAL
AX-2025-020581	SSA-2502-D7226	Janoshik	2025-Q3	97.83	6.53	96.6	Supplier-supplied	1	MARGINAL
AX-2025-020582	SSA-2502-D7226	PeptideMeter	2025-Q3	97.70	6.61	100.1	Laboratory-retained	1	MARGINAL
AX-2025-020584	SSA-2502-D7226	PeptideMeter	2025-Q3	97.97	6.65	101.5	Buyer-sourced	1	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 SSA records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043135	BPC-157	SSA-2601-N6863	Nordanalyt	2026-Q2	98.16	4.66	92.8	Buyer-sourced	1	MARGINAL
AX-2026-043160	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.01	4.02	91.8	Buyer-sourced	0	PASS
AX-2026-043157	GHK-Cu	SSA-2604-V7731	Medutest	2026-Q2	99.19	5.14	—	Supplier-supplied	0	PASS
AX-2026-043141	BPC-157	SSA-2601-N6863	Janoshik	2026-Q2	98.06	4.06	94.6	Buyer-sourced	1	MARGINAL
AX-2026-043154	GHK-Cu	SSA-2604-V7731	PeptideMeter	2026-Q2	97.82	4.82	101.6	Buyer-sourced	0	PASS
AX-2026-043137	BPC-157	SSA-2601-N6863	PeptideMeter	2026-Q2	98.17	4.14	—	Buyer-sourced	1	MARGINAL
AX-2026-043162	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.50	4.36	—	Supplier-supplied	0	PASS
AX-2026-043134	BPC-157	SSA-2601-N6863	Medutest	2026-Q2	97.89	4.01	—	Buyer-sourced	1	FAIL