AX-2024-005307 · Tirzepatide · BCH lot BCH-2404-N5218

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, 28 min gradient, 214 nm	98.10	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.90	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — Met(O) sulfoxide (+16 Da)	1.11	% area	≤ 1.00	FAIL
Identity — theoretical monoisotopic mass	calculated from molecular formula	4810.4103	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	4810.4180	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+1.6	ppm	± 15	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	3.32	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	6.76	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.60	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.31	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 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	5.03	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 28 min gradient	18.86	min	18.64 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.61	—	0.80 – 1.50	FAIL
Plate count, main peak	N = 5.54 (t/w½)²	56,427	—	≥ 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, 28 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 56,427, and skew follows the reported asymmetry factor of 1.61. 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 1.11 % impurity against a 98.10 % 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	18.86	4,767,964	98.10	—
2	Met(O) sulfoxide (+16 Da)	18.17	53,949	1.11	+15.995
3	[D-Aib13]-diastereomer	18.68	17,011	0.35	0.000
4	truncated (3-39)	17.48	14,581	0.30	-222.112
5	des-Aib2 analogue	18.53	4,860	0.10	-85.053
6	tirzepatide dimer	22.57	972	0.02	+4810.410
7	trifluoroacetyl adduct (+96 Da)	19.73	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, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 4810.4180 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	688.2098	0.0011	8.0
6+	802.7423	802.7436	0.0013	50.2
5+	963.0893	963.0909	0.0016	100.0
4+	1203.6099	1203.6118	0.0019	56.9
3+	1604.4774	1604.4799	0.0025	7.7

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.

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)	97.97	98.10	divergence +0.34 pp vs batch median
Total impurities (% area)	2.03	1.90
Largest single impurity (% area)	1.24	1.11
Water (%)	not stated	3.32
Counter-ion (%)	not stated	6.76
Peptide content (%w/w)	91.7	not determined
Endotoxin (EU/mg)	0.30	0.31
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, 7 d) → assay. Submitter did not handle the vial.
Assay date: 15 Jul 2024
Submitted to the index: 08 Aug 2024
Laboratory: PeptideMeter, Tallinn, Estonia
Method basis: 28 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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 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 4

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.

ms_confirm08 Aug 2024

+1.6 ppm at this mass is a clean identity confirmation. With retention at 18.86 min, Tirzepatide is established as the species measured. Note what it does not exclude: a mass-identical diastereomer, which no mass measurement of any resolution can.

esi_tof08 Aug 2024

Mass, retention and impurity profile all agree on this record. Three independent constraints pointing the same way is the strongest identity evidence the index publishes.

nmr_qnmr08 Aug 2024

Mass at +1.6 ppm establishes identity but not content. Absolute content needs a standard or an orthogonal quantitative method, and neither is a mass spectrometer.

macrolactam08 Aug 2024

For any sequence closed head-to-side-chain, the uncyclised precursor differs by 18 Da and is trivially separable by mass. The envelope on this record shows nothing at that offset.

Section 7

Related records

Same batch — lot BCH-2404-N5218 n=11

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005297	BCH-2404-N5218	VendorInvestigate	2024-Q3	97.21	3.86	—	Buyer-sourced	0	PASS
AX-2024-005298	BCH-2404-N5218	Janoshik	2024-Q3	97.63	3.74	97.1	Buyer-sourced	0	PASS
AX-2024-005299	BCH-2404-N5218	Janoshik	2024-Q3	97.26	3.22	—	Buyer-sourced	0	PASS
AX-2024-005300	BCH-2404-N5218	Janoshik	2024-Q3	97.73	3.35	102.9	Buyer-sourced	0	PASS
AX-2024-005301	BCH-2404-N5218	VendorInvestigate	2024-Q3	97.29	3.59	—	Buyer-sourced	0	PASS
AX-2024-005302	BCH-2404-N5218	Janoshik	2024-Q3	97.51	3.68	101.5	Buyer-sourced	0	PASS
AX-2024-005303	BCH-2404-N5218	PeptideMeter	2024-Q3	97.75	2.86	101.4	Buyer-sourced	0	PASS
AX-2024-005304	BCH-2404-N5218	Janoshik	2024-Q3	98.49	3.04	—	Supplier-supplied	1	MARGINAL
AX-2024-005305	BCH-2404-N5218	Medutest	2024-Q3	98.44	3.70	92.6	Supplier-supplied	1	MARGINAL
AX-2024-005306	BCH-2404-N5218	Janoshik	2024-Q3	97.60	3.79	104.0	Laboratory-retained	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 BCH records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043445	BPC-157	BCH-2603-G4350	Nordanalyt	2026-Q3	98.42	4.87	93.6	Buyer-sourced	1	MARGINAL
AX-2026-043440	BPC-157	BCH-2603-G4350	VendorInvestigate	2026-Q3	98.61	4.11	—	Buyer-sourced	1	MARGINAL
AX-2026-043442	BPC-157	BCH-2603-G4350	Janoshik	2026-Q3	98.65	4.78	—	Buyer-sourced	1	MARGINAL
AX-2026-043471	CJC-1295 with DAC	BCH-2607-H5235	Janoshik	2026-Q3	97.46	5.48	—	Buyer-sourced	1	FAIL
AX-2026-043477	CJC-1295 with DAC	BCH-2607-H5235	VendorInvestigate	2026-Q3	97.62	5.32	99.6	Buyer-sourced	1	MARGINAL
AX-2026-043449	BPC-157	BCH-2603-G4350	Kestrel	2026-Q3	99.74	4.92	91.3	Supplier-supplied	2	MARGINAL
AX-2026-043448	BPC-157	BCH-2603-G4350	Janoshik	2026-Q3	98.55	4.69	106.9	Buyer-sourced	1	MARGINAL
AX-2026-043470	CJC-1295 with DAC	BCH-2607-H5235	Janoshik	2026-Q3	97.76	6.11	99.3	Supplier-supplied	1	MARGINAL