AX-2026-042392

Tirzepatide · 10 mg declared · Hunan Aslsen Technology Co., Ltd. · lot HOMO-2601-N4081

PASSPURITY ONLY

Report ID: AX-2026-042392
Compound: Tirzepatide
Compound class: Incretin analogues and co-agonists
Supplier: Homopeptide — Hunan Aslsen Technology Co., Ltd.
Batch / lot: HOMO-2601-N4081
Declared label claim: 10mg
Laboratory: Nordanalyt Laboratories
Assay date: 15 Apr 2026
Submitted: 27 Apr 2026
Quarter: 2026-Q2
Submitter: d.antonsen
Sample provenance: Laboratory-retained

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, 35 min gradient, 214 nm	98.92	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.08	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — trifluoroacetyl adduct (+96 Da)	0.78	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	84.23	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	83.32	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	11.22	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	9.349	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	93.5	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.86	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	9.21	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.70	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.86	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 to pale-yellow 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	4.46	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	23.01	min	22.91 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.04	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	25,039	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib13]-diastereomer	0.37	—	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, 35 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 25,039, and skew follows the reported asymmetry factor of 1.04. 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 0.78 % impurity against a 98.92 % 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	23.01	4,807,819	98.92	—
2	trifluoroacetyl adduct (+96 Da)	24.10	37,910	0.78	+95.982
3	[D-Aib13]-diastereomer	22.79	10,207	0.21	0.000
4	Met(O) sulfoxide (+16 Da)	22.15	2,916	0.06	+15.995
5	truncated (3-39)	21.28	972	0.02	-222.112
6	tirzepatide dimer	27.65	486	0.01	+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 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	5.86
Counter-ion (TFA)	ion chromatography	9.21
Residual solvent + inorganic residue	estimated	0.70
Total peptide content	by difference	84.23
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)	99.62	98.92	divergence +0.67 pp vs batch median
Total impurities (% area)	0.38	1.08
Largest single impurity (% area)	0.13	0.78
Water (%)	3.7	5.86
Counter-ion (%)	6.6	9.21
Peptide content (%w/w)	89.1	84.23
Endotoxin (EU/mg)	not stated	0.86
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, 31 d since original receipt) → re-assay.
Assay date: 15 Apr 2026
Submitted to the index: 27 Apr 2026
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 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.
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_28027 Apr 2026

If the nearest impurity carries an aromatic residue the parent lacks, dual-wavelength detection separates them without any chromatographic change at all. Cheap and underused.

c18_2p627 Apr 2026

Doubling column length gains 40 % resolution and doubles the run. On a routine release method that trade is usually declined, and the certificate should say which method was run.

Section 7

Related records

Same batch — lot HOMO-2601-N4081 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042386	HOMO-2601-N4081	Janoshik	2026-Q2	98.90	4.85	105.6	Buyer-sourced	PASS
AX-2026-042387	HOMO-2601-N4081	Janoshik	2026-Q2	98.90	5.37	92.5	Laboratory-retained	PASS
AX-2026-042388	HOMO-2601-N4081	Nordanalyt	2026-Q2	99.05	5.34	97.2	Buyer-sourced	PASS
AX-2026-042389	HOMO-2601-N4081	Janoshik	2026-Q2	98.97	4.63	—	Buyer-sourced	PASS
AX-2026-042390	HOMO-2601-N4081	VendorInvestigate	2026-Q2	99.28	5.11	—	Buyer-sourced	PASS
AX-2026-042391	HOMO-2601-N4081	Janoshik	2026-Q2	98.43	4.99	—	Buyer-sourced	PASS
AX-2026-042393	HOMO-2601-N4081	Kestrel	2026-Q2	99.84	5.10	95.3	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 Homopeptide records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042437	Retatrutide	HOMO-2605-V4718	Nordanalyt	2026-Q3	98.68	3.67	102.8	Buyer-sourced	PASS
AX-2026-042424	Semaglutide	HOMO-2604-X3806	PeptideMeter	2026-Q3	98.85	4.87	92.0	Buyer-sourced	PASS
AX-2026-042503	IGF-1 LR3	HOMO-2607-P5131	Janoshik	2026-Q3	99.36	5.99	—	Buyer-sourced	PASS
AX-2026-042492	SS-31 (Elamipretide)	HOMO-2604-D5484	Medutest	2026-Q3	99.93	2.40	—	Buyer-sourced	PASS
AX-2026-042491	SS-31 (Elamipretide)	HOMO-2604-D5484	Kestrel	2026-Q3	99.93	3.24	—	Supplier-supplied	PASS
AX-2026-042473	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.01	5.00	—	Buyer-sourced	PASS
AX-2026-042441	Retatrutide	HOMO-2605-V4718	Medutest	2026-Q3	98.93	4.22	—	Buyer-sourced	PASS
AX-2026-042474	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.18	5.44	—	Buyer-sourced	PASS