AX-2024-005275 · Tirzepatide · BCH lot BCH-2407-F4650

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	96.98	% area	≥ 97.0	FAIL
Total impurities	RP-HPLC, sum of reported peaks	3.02	% area	≤ 3.0	FAIL
Largest single impurity	RP-HPLC — C20 diacid mono-amide	1.46	% 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)	4810.4267	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+3.4	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	86.74	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	84.12	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	66.89	mg	60 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	56.268	mg	60 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	93.8	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.18	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	7.55	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.53	%	—	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 with a single visible fibre	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	2.66	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	19.72	min	19.86 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.05	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	56,111	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib13]-diastereomer	0.56	—	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 56,111, and skew follows the reported asymmetry factor of 1.05. 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 1.46 % impurity against a 96.98 % 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	19.72	4,713,529	96.98	—
2	C20 diacid mono-amide	21.34	70,961	1.46	+0.984
3	[D-Aib13]-diastereomer	19.53	46,659	0.96	0.000
4	des-Aib2 analogue	19.37	17,011	0.35	-85.053
5	des-Gly deletion (−57 Da)	19.11	5,346	0.11	-57.021
6	trifluoroacetyl adduct (+96 Da)	20.65	4,860	0.10	+95.982
7	Met(O) sulfoxide (+16 Da)	18.98	1,944	0.04	+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 4810.4267 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	688.2111	0.0024	8.8
6+	802.7423	802.7451	0.0028	55.5
5+	963.0893	963.0926	0.0033	100.0
4+	1203.6099	1203.6140	0.0041	51.0
3+	1604.4774	1604.4828	0.0054	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	5.18
Counter-ion (TFA)	ion chromatography	7.55
Residual solvent + inorganic residue	estimated	0.53
Total peptide content	by difference	86.74
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)	97.42	96.98	divergence +0.09 pp vs batch median
Total impurities (% area)	1.04	3.02
Largest single impurity (% area)	2.58	1.46
Water (%)	not stated	5.18
Counter-ion (%)	3.1	7.55
Peptide content (%w/w)	92.8	86.74
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, 30 d) → laboratory (courier, cold pack, 11 d) → assay.
Assay date: 19 Oct 2024
Submitted to the index: 06 Nov 2024
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 5

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.

scale_up_delta06 Nov 2024

Purity commonly falls a few tenths between pilot and production scale, and a result below a laboratory-batch figure is the most ordinary thing in this dataset. Comparing a commercial lot against a research-batch certificate compares two different processes.

lambda_28006 Nov 2024

Aromatic-selective detection at 280 nm would identify whether C20 diacid mono-amide carries the chromophore. That distinguishes a truncation from a modification in about ten minutes of instrument time.

mass_defect06 Nov 2024

Before assigning C20 diacid mono-amide from retention alone, check the mass defect on the impurity peak. Plausible and implausible assignments separate cleanly and the check costs nothing.

survivor_lots06 Nov 2024

Lots get submitted for two reasons: somebody submits everything, or somebody was surprised. The second reason over-represents results in this band across the whole index, and the aggregate caveat exists for it.

acetate_only06 Nov 2024

Seconded.

Section 7

Related records

Same batch — lot BCH-2407-F4650 n=9

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005273	BCH-2407-F4650	Janoshik	2024-Q4	98.15	4.80	—	Supplier-supplied	2	MARGINAL
AX-2024-005274	BCH-2407-F4650	Janoshik	2024-Q4	97.23	5.76	89.3	Buyer-sourced	3	MARGINAL
AX-2024-005276	BCH-2407-F4650	PeptideMeter	2024-Q4	97.17	5.02	107.1	Supplier-supplied	2	MARGINAL
AX-2024-005277	BCH-2407-F4650	Janoshik	2024-Q4	97.17	5.40	91.4	Buyer-sourced	2	MARGINAL
AX-2024-005278	BCH-2407-F4650	Janoshik	2024-Q4	97.33	5.55	92.4	Buyer-sourced	2	MARGINAL
AX-2024-005279	BCH-2407-F4650	Kestrel	2024-Q4	97.81	5.59	—	Supplier-supplied	2	MARGINAL
AX-2024-005280	BCH-2407-F4650	Kestrel	2024-Q4	98.39	5.02	—	Buyer-sourced	2	MARGINAL
AX-2024-005281	BCH-2407-F4650	Janoshik	2024-Q4	97.76	4.99	89.9	Supplier-supplied	3	MARGINAL

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