AX-2025-021335 · Tirzepatide · BCH lot BCH-2508-A7959

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	98.62	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.38	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — des-Aib2 analogue	0.86	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	4810.4103	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	4810.4060	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-0.9	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	87.19	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	85.99	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	63.11	mg	60 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	54.268	mg	60 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	90.4	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.27	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	6.75	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.79	%	—	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 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	3.43	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	19.85	min	19.86 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.15	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	50,193	—	≥ 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, 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 50,193, and skew follows the reported asymmetry factor of 1.15. 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 0.86 % impurity against a 98.62 % 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	19.85	4,793,238	98.62	—
2	des-Aib2 analogue	19.50	41,799	0.86	-85.053
3	trifluoroacetyl adduct (+96 Da)	20.78	11,665	0.24	+95.982
4	truncated (3-39)	18.37	6,318	0.13	-222.112
5	tirzepatide dimer	23.83	4,860	0.10	+4810.410
6	[D-Aib13]-diastereomer	19.66	1,458	0.03	0.000
7	Met(O) sulfoxide (+16 Da)	19.11	972	0.02	+15.995
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, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 4810.4060 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	688.2081	-0.0006	7.9
6+	802.7423	802.7416	-0.0007	50.1
5+	963.0893	963.0885	-0.0008	100.0
4+	1203.6099	1203.6088	-0.0011	55.3
3+	1604.4774	1604.4759	-0.0015	8.7

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	5.27
Counter-ion (TFA)	ion chromatography	6.75
Residual solvent + inorganic residue	estimated	0.79
Total peptide content	by difference	87.19
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)	98.72	98.62	divergence -0.19 pp vs batch median
Total impurities (% area)	1.28	1.38
Largest single impurity (% area)	0.73	0.86
Water (%)	not stated	5.27
Counter-ion (%)	not stated	6.75
Peptide content (%w/w)	not stated	87.19
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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Domestic warehouse despatch → submitter (2–8 °C, 15 d) → laboratory (courier, cold pack, 4 d) → assay.
Assay date: 26 Aug 2025
Submitted to the index: 05 Sep 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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 BCH-2508-A7959 n=12

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-021325	BCH-2508-A7959	Janoshik	2025-Q3	98.77	5.14	91.5	Buyer-sourced	1	FAIL
AX-2025-021326	BCH-2508-A7959	Medutest	2025-Q3	98.90	5.13	102.7	Laboratory-retained	0	PASS
AX-2025-021327	BCH-2508-A7959	Medutest	2025-Q3	99.28	5.50	89.2	Buyer-sourced	1	MARGINAL
AX-2025-021328	BCH-2508-A7959	Janoshik	2025-Q3	98.82	5.30	102.9	Buyer-sourced	0	PASS
AX-2025-021329	BCH-2508-A7959	Janoshik	2025-Q3	98.34	5.23	94.3	Buyer-sourced	0	PASS
AX-2025-021330	BCH-2508-A7959	Janoshik	2025-Q3	98.89	5.09	—	Buyer-sourced	0	PASS
AX-2025-021331	BCH-2508-A7959	Nordanalyt	2025-Q3	99.15	4.76	101.2	Supplier-supplied	0	PASS
AX-2025-021332	BCH-2508-A7959	Janoshik	2025-Q3	98.91	5.40	—	Buyer-sourced	1	MARGINAL
AX-2025-021333	BCH-2508-A7959	Janoshik	2025-Q3	99.30	5.52	102.9	Supplier-supplied	0	PASS
AX-2025-021334	BCH-2508-A7959	Medutest	2025-Q3	99.55	4.74	95.4	Buyer-sourced	0	PASS
AX-2025-021336	BCH-2508-A7959	VendorInvestigate	2025-Q3	98.98	5.19	94.3	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	Flags	Result
AX-2026-043445	CPC	CPC-2607-L3107	PeptideMeter	2026-Q3	97.16	4.43	102.8	Supplier-supplied	0	PASS
AX-2026-042137	TFC	TFC-2605-G7465	Janoshik	2026-Q3	98.55	6.50	92.6	Buyer-sourced	0	PASS
AX-2026-042148	TFC	TFC-2605-G7465	Medutest	2026-Q3	98.59	6.97	—	Buyer-sourced	0	PASS
AX-2026-043440	CPC	CPC-2607-L3107	VendorInvestigate	2026-Q3	96.03	5.46	105.8	Buyer-sourced	0	FAIL
AX-2026-042147	TFC	TFC-2605-G7465	Janoshik	2026-Q3	98.50	6.41	89.5	Buyer-sourced	1	MARGINAL
AX-2026-041734	FGP	FGP-2603-L9122	PeptideMeter	2026-Q3	99.06	2.92	102.2	Buyer-sourced	0	PASS
AX-2026-043448	CPC	CPC-2607-L3107	Medutest	2026-Q3	97.21	5.42	107.0	Supplier-supplied	0	PASS
AX-2026-042144	TFC	TFC-2605-G7465	Kestrel	2026-Q3	98.64	6.08	102.1	Buyer-sourced	0	PASS

Other recent BCH records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043691	BPC-157	BCH-2603-L7768	Janoshik	2026-Q3	98.66	5.12	—	Supplier-supplied	1	MARGINAL
AX-2026-043693	BPC-157	BCH-2603-L7768	PeptideMeter	2026-Q3	97.82	5.21	94.9	Buyer-sourced	0	FAIL
AX-2026-043686	BPC-157	BCH-2603-L7768	VendorInvestigate	2026-Q3	97.64	5.27	—	Buyer-sourced	0	FAIL
AX-2026-043695	BPC-157	BCH-2603-L7768	Janoshik	2026-Q3	97.61	5.42	—	Buyer-sourced	0	FAIL
AX-2026-043726	N-Acetyl Semax Amide	BCH-2602-E8475	Janoshik	2026-Q3	97.89	9.67	104.2	Buyer-sourced	0	FAIL
AX-2026-043688	BPC-157	BCH-2603-L7768	Janoshik	2026-Q3	97.94	5.56	—	Buyer-sourced	0	FAIL
AX-2026-043658	BPC-157	BCH-2603-G6644	Janoshik	2026-Q3	98.45	4.37	101.8	Supplier-supplied	0	PASS
AX-2026-043692	BPC-157	BCH-2603-L7768	VendorInvestigate	2026-Q3	97.60	5.61	—	Buyer-sourced	0	FAIL