AX-2025-018644 · Tirzepatide · QSC lot QSC-2408-T5296

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	99.74	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.26	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — [D-Aib13]-diastereomer	0.15	% 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)	4810.3944	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-3.3	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	83.62	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	83.40	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	32.99	mg	30 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	27.514	mg	30 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	91.7	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	6.51	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	9.03	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.84	%	—	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	Off-white lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Visible particulates, did not clear	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	3.59	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	16.56	min	16.81 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.08	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	54,292	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib13]-diastereomer	0.54	—	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 54,292, and skew follows the reported asymmetry factor of 1.08. 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 0.15 % impurity against a 99.74 % 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	16.56	4,847,673	99.74	—
2	[D-Aib13]-diastereomer	16.40	7,290	0.15	0.000
3	C20 diacid mono-amide	17.91	2,916	0.06	+0.984
4	des-Gly deletion (−57 Da)	16.05	1,458	0.03	-57.021
5	trifluoroacetyl adduct (+96 Da)	17.33	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 4810.3944 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	688.2065	-0.0022	7.6
6+	802.7423	802.7397	-0.0026	53.7
5+	963.0893	963.0862	-0.0031	100.0
4+	1203.6099	1203.6059	-0.0040	57.1
3+	1604.4774	1604.4721	-0.0053	8.5

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	6.51
Counter-ion (TFA)	ion chromatography	9.03
Residual solvent + inorganic residue	estimated	0.84
Total peptide content	by difference	83.62
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	99.74	divergence +0.02 pp vs batch median
Total impurities (% area)	0.10	0.26
Largest single impurity (% area)	0.07	0.15
Water (%)	5.2	6.51
Counter-ion (%)	not stated	9.03
Peptide content (%w/w)	not stated	83.62
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: Laboratory-retained
Evidentiary weight: Provenance documented, selection uncontrolled.
Chain of custody: Laboratory retained sample (−20 °C, 28 d since original receipt) → re-assay.
Assay date: 19 Feb 2025
Submitted to the index: 16 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.
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 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.

median_not_mean16 Mar 2025

One result at the top of the distribution should not move anybody's estimate much on its own. Purity distributions are compressed at the top and long-tailed at the bottom, so the informative observations are the low ones.

ms_confirm16 Mar 2025

A reference standard on the same sequence would upgrade this from a good mass to a traceable one. The distinction matters where a result is going to be cited rather than merely read.

valley_drop16 Mar 2025

[D-Aib13]-diastereomer at 0.15 % elutes close enough to the main peak that drop-line and valley-to-valley will not agree. The index prints the resolution figure and applies no criterion to it — how close the nearest impurity sits is a property of the compound and the gradient, not of the system. What matters is that the convention used is stated.

Section 7

Related records

Same batch — lot QSC-2408-T5296 n=12

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-018634	QSC-2408-T5296	Janoshik	2025-Q1	99.93	5.67	—	Buyer-sourced	0	PASS
AX-2025-018635	QSC-2408-T5296	Janoshik	2025-Q1	99.61	5.40	104.8	Buyer-sourced	0	PASS
AX-2025-018636	QSC-2408-T5296	Nordanalyt	2025-Q1	99.93	5.63	101.3	Buyer-sourced	0	PASS
AX-2025-018637	QSC-2408-T5296	Medutest	2025-Q1	99.43	5.27	101.9	Buyer-sourced	0	PASS
AX-2025-018638	QSC-2408-T5296	Janoshik	2025-Q1	99.84	5.73	—	Buyer-sourced	0	PASS
AX-2025-018639	QSC-2408-T5296	Janoshik	2025-Q1	99.62	5.07	—	Buyer-sourced	0	PASS
AX-2025-018640	QSC-2408-T5296	Kestrel	2025-Q1	99.93	5.39	89.9	Buyer-sourced	1	MARGINAL
AX-2025-018641	QSC-2408-T5296	Janoshik	2025-Q1	99.93	5.85	—	Buyer-sourced	1	MARGINAL
AX-2025-018642	QSC-2408-T5296	Janoshik	2025-Q1	99.91	5.57	98.7	Buyer-sourced	0	PASS
AX-2025-018643	QSC-2408-T5296	Nordanalyt	2025-Q1	99.91	5.68	96.2	Buyer-sourced	0	PASS
AX-2025-018645	QSC-2408-T5296	Medutest	2025-Q1	99.59	5.29	95.4	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 QSC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041599	CJC-1295 (no DAC)	QSC-2606-V7416	VendorInvestigate	2026-Q3	97.96	3.52	—	Buyer-sourced	1	FAIL
AX-2026-041601	CJC-1295 (no DAC)	QSC-2606-V7416	Kestrel	2026-Q3	98.33	4.10	—	Buyer-sourced	1	MARGINAL
AX-2026-041602	CJC-1295 (no DAC)	QSC-2606-V7416	VendorInvestigate	2026-Q3	98.36	3.38	101.8	Buyer-sourced	1	MARGINAL
AX-2026-041477	Triptorelin	QSC-2607-C5749	Nordanalyt	2026-Q3	99.53	3.42	—	Buyer-sourced	0	PASS
AX-2026-041600	CJC-1295 (no DAC)	QSC-2606-V7416	Nordanalyt	2026-Q3	97.74	4.91	100.9	Buyer-sourced	1	FAIL
AX-2026-041603	CJC-1295 (no DAC)	QSC-2606-V7416	PeptideMeter	2026-Q3	98.43	4.20	—	Buyer-sourced	1	MARGINAL
AX-2026-041606	CJC-1295 (no DAC)	QSC-2606-V7416	Janoshik	2026-Q3	98.03	3.58	—	Buyer-sourced	1	MARGINAL
AX-2026-041585	Liraglutide	QSC-2605-W7381	Medutest	2026-Q3	99.59	5.09	92.8	Laboratory-retained	0	PASS