AX-2024-004678

Tirzepatide · 15 mg declared · Tianjin Finder Chemical Co., Ltd. · lot TFC-2401-J7929

MARGINALMETHOD LIMITED

Report ID: AX-2024-004678
Compound: Tirzepatide
Compound class: Incretin analogues and co-agonists
Supplier: TFC — Tianjin Finder Chemical Co., Ltd.
Batch / lot: TFC-2401-J7929
Declared label claim: 15mg
Laboratory: Kestrel Bioanalytical
Assay date: 02 Feb 2024
Submitted: 09 Feb 2024
Quarter: 2024-Q1
Submitter: k.vermeulen
Sample provenance: Supplier-supplied

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	97.79	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	2.21	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — C20 diacid mono-amide	1.33	% area	≤ 1.00	FAIL
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	6.14	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	5.73	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.52	%	—	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	White cake, partially collapsed	—	white to off-white intact cake	FAIL
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	3.41	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	10.59	min	10.72 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.09	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	56,269	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib13]-diastereomer	0.52	—	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 56,269, and skew follows the reported asymmetry factor of 1.09. 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 1.33 % impurity against a 97.79 % 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	10.59	4,752,897	97.79	—
2	C20 diacid mono-amide	11.40	64,642	1.33	+0.984
3	des-Gly deletion (−57 Da)	10.29	25,274	0.52	-57.021
4	des-Aib2 analogue	10.41	11,665	0.24	-85.053
5	Met(O) sulfoxide (+16 Da)	10.22	3,888	0.08	+15.995
6	[D-Aib13]-diastereomer	10.49	972	0.02	0.000
7	truncated (3-39)	9.85	972	0.02	-222.112
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)	98.62	97.79	divergence +0.62 pp vs batch median
Total impurities (% area)	1.38	2.21
Largest single impurity (% area)	1.00	1.33
Water (%)	5.8	6.14
Counter-ion (%)	not stated	5.73
Peptide content (%w/w)	89.4	not determined
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, 2 d) → assay. Submitter did not handle the vial.
Assay date: 02 Feb 2024
Submitted to the index: 09 Feb 2024
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 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 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.
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 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

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot TFC-2401-J7929 n=12

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004672	TFC-2401-J7929	PeptideMeter	2024-Q1	97.63	6.85	—	Supplier-supplied	2	MARGINAL
AX-2024-004673	TFC-2401-J7929	Janoshik	2024-Q1	97.72	6.58	106.5	Supplier-supplied	2	MARGINAL
AX-2024-004674	TFC-2401-J7929	Janoshik	2024-Q1	98.74	6.39	101.4	Supplier-supplied	2	MARGINAL
AX-2024-004675	TFC-2401-J7929	Janoshik	2024-Q1	98.00	5.96	101.8	Supplier-supplied	2	MARGINAL
AX-2024-004676	TFC-2401-J7929	Nordanalyt	2024-Q1	98.00	6.90	—	Supplier-supplied	2	MARGINAL
AX-2024-004677	TFC-2401-J7929	Janoshik	2024-Q1	97.90	6.80	—	Supplier-supplied	2	MARGINAL
AX-2024-004679	TFC-2401-J7929	Janoshik	2024-Q1	98.59	6.17	96.8	Supplier-supplied	2	MARGINAL
AX-2024-004680	TFC-2401-J7929	Nordanalyt	2024-Q1	98.35	6.02	95.2	Supplier-supplied	2	MARGINAL
AX-2024-004681	TFC-2401-J7929	Janoshik	2024-Q1	98.01	5.69	94.4	Supplier-supplied	2	MARGINAL
AX-2024-004682	TFC-2401-J7929	Janoshik	2024-Q1	98.91	6.67	—	Supplier-supplied	2	MARGINAL
AX-2024-004683	TFC-2401-J7929	VendorInvestigate	2024-Q1	96.82	7.03	—	Buyer-sourced	3	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Tirzepatide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043106	KP	KP-2608-D5921	PeptideMeter	2026-Q3	98.90	5.45	105.4	Supplier-supplied	2	MARGINAL
AX-2026-041742	FGP	FGP-2603-L9714	Janoshik	2026-Q3	99.37	2.43	105.5	Supplier-supplied	1	MARGINAL
AX-2026-043108	KP	KP-2608-D5921	Janoshik	2026-Q3	99.70	5.45	—	Supplier-supplied	2	MARGINAL
AX-2026-041741	FGP	FGP-2603-L9714	PeptideMeter	2026-Q3	98.62	2.57	—	Supplier-supplied	1	MARGINAL
AX-2026-043100	KP	KP-2608-D5921	VendorInvestigate	2026-Q3	98.27	5.31	94.4	Buyer-sourced	2	MARGINAL
AX-2026-043322	CPC	CPC-2607-L2552	Janoshik	2026-Q3	96.79	4.88	96.1	Supplier-supplied	2	FAIL
AX-2026-043111	KP	KP-2608-D5921	PeptideMeter	2026-Q3	99.71	5.15	—	Supplier-supplied	2	MARGINAL
AX-2026-043321	CPC	CPC-2607-L2552	Kestrel	2026-Q3	97.84	5.34	—	Supplier-supplied	2	MARGINAL

Other recent TFC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041932	Semaglutide	TFC-2604-X4301	Janoshik	2026-Q3	98.88	4.31	—	Supplier-supplied	0	PASS
AX-2026-042067	SS-31 (Elamipretide)	TFC-2604-Y7472	Kestrel	2026-Q3	98.66	4.44	—	Supplier-supplied	1	MARGINAL
AX-2026-042057	Sermorelin	TFC-2605-Y6440	Janoshik	2026-Q3	98.68	3.94	98.3	Supplier-supplied	0	PASS
AX-2026-041936	Semaglutide	TFC-2604-X4301	PeptideMeter	2026-Q3	98.62	4.30	—	Buyer-sourced	1	MARGINAL
AX-2026-041973	Humanin (HNG)	TFC-2605-U5564	Janoshik	2026-Q3	99.62	7.03	—	Supplier-supplied	2	FAIL
AX-2026-041980	Humanin (HNG)	TFC-2605-U5564	Janoshik	2026-Q3	99.90	7.01	88.6	Supplier-supplied	2	MARGINAL
AX-2026-041961	Tirzepatide	TFC-2605-G5134	Medutest	2026-Q3	98.25	7.11	—	Supplier-supplied	2	MARGINAL
AX-2026-042068	SS-31 (Elamipretide)	TFC-2604-Y7472	Medutest	2026-Q3	98.71	3.63	92.9	Supplier-supplied	2	MARGINAL