AX-2024-005149

Tirzepatide · 60 mg declared · Sangon Biotech (Shanghai) Co., Ltd. · lot SGN-2401-K9783

PASSIDENTITY CONSISTENT

Report ID: AX-2024-005149
Compound: Tirzepatide
Compound class: Incretin analogues and co-agonists
Supplier: SGN — Sangon Biotech (Shanghai) Co., Ltd.
Batch / lot: SGN-2401-K9783
Declared label claim: 60mg
Laboratory: Janoshik Analytical
Assay date: 14 Jun 2024
Submitted: 24 Jun 2024
Quarter: 2024-Q2
Submitter: mi.ibarra
Sample provenance: Buyer-sourced

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	98.19	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.81	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — [D-Aib13]-diastereomer	1.06	% 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)	4810.4223	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+2.5	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	4.14	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	6.45	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.43	%	—	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 to pale-yellow cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Clear after 90 s gentle swirling, no particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	3.56	—	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	1.10	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	65,969	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib13]-diastereomer	0.60	—	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 65,969, and skew follows the reported asymmetry factor of 1.10. 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 1.06 % impurity against a 98.19 % 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	4,772,338	98.19	—
2	[D-Aib13]-diastereomer	19.66	51,519	1.06	0.000
3	trifluoroacetyl adduct (+96 Da)	20.78	24,788	0.51	+95.982
4	Met(O) sulfoxide (+16 Da)	19.11	5,346	0.11	+15.995
5	C20 diacid mono-amide	21.47	3,888	0.08	+0.984
6	des-Aib2 analogue	19.50	1,458	0.03	-85.053
7	tirzepatide dimer	23.83	972	0.02	+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 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 4810.4223 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	688.2105	0.0018	7.7
6+	802.7423	802.7443	0.0020	51.2
5+	963.0893	963.0917	0.0024	100.0
4+	1203.6099	1203.6129	0.0030	50.0
3+	1604.4774	1604.4814	0.0040	8.3

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)	98.64	98.19	divergence +0.48 pp vs batch median
Total impurities (% area)	1.36	1.81
Largest single impurity (% area)	not stated	1.06
Water (%)	3.9	4.14
Counter-ion (%)	not stated	6.45
Peptide content (%w/w)	91.3	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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Retail purchase → submitter (−20 °C, 31 d) → laboratory (courier, dry ice, 8 d) → assay.
Assay date: 14 Jun 2024
Submitted to the index: 24 Jun 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: IDENTITY CONSISTENT

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 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 1

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.

storage_stated24 Jun 2024

Stated storage conditions on the certificate against the observed transit conditions in the custody block: on this record they agree, which removes one class of explanation for anything unexpected.

Section 7

Related records

Same batch — lot SGN-2401-K9783 n=15

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005147	SGN-2401-K9783	Medutest	2024-Q2	98.00	4.14	101.3	Buyer-sourced	1	FAIL
AX-2024-005148	SGN-2401-K9783	Medutest	2024-Q2	97.86	4.64	—	Buyer-sourced	0	PASS
AX-2024-005150	SGN-2401-K9783	PeptideMeter	2024-Q2	98.22	3.92	97.1	Buyer-sourced	0	PASS
AX-2024-005151	SGN-2401-K9783	VendorInvestigate	2024-Q2	97.91	4.24	—	Buyer-sourced	0	PASS
AX-2024-005152	SGN-2401-K9783	Janoshik	2024-Q2	98.15	3.83	92.0	Buyer-sourced	0	PASS
AX-2024-005153	SGN-2401-K9783	PeptideMeter	2024-Q2	98.29	4.42	98.2	Buyer-sourced	1	MARGINAL
AX-2024-005154	SGN-2401-K9783	Kestrel	2024-Q2	99.72	4.08	105.6	Supplier-supplied	1	MARGINAL
AX-2024-005155	SGN-2401-K9783	Janoshik	2024-Q2	98.55	4.39	—	Buyer-sourced	0	PASS
AX-2024-005156	SGN-2401-K9783	Janoshik	2024-Q2	98.16	4.02	—	Buyer-sourced	0	PASS
AX-2024-005157	SGN-2401-K9783	VendorInvestigate	2024-Q2	97.83	4.30	107.5	Buyer-sourced	0	PASS
AX-2024-005158	SGN-2401-K9783	Janoshik	2024-Q2	98.04	3.87	—	Buyer-sourced	0	PASS
AX-2024-005159	SGN-2401-K9783	PeptideMeter	2024-Q2	98.15	4.59	89.5	Buyer-sourced	1	MARGINAL
AX-2024-005160	SGN-2401-K9783	Nordanalyt	2024-Q2	98.26	4.03	88.9	Buyer-sourced	1	MARGINAL
AX-2024-005161	SGN-2401-K9783	VendorInvestigate	2024-Q2	98.34	4.44	98.2	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	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 SGN records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043233	Afamelanotide	SGN-2602-Y9306	Janoshik	2026-Q3	98.76	4.02	92.2	Buyer-sourced	1	MARGINAL
AX-2026-043234	Afamelanotide	SGN-2602-Y9306	Kestrel	2026-Q3	99.93	4.16	—	Buyer-sourced	0	PASS
AX-2026-043240	SLU-PP-332	SGN-2602-X9377	Janoshik	2026-Q2	98.82	5.46	97.0	Buyer-sourced	0	PASS
AX-2026-043222	ARA-290	SGN-2605-X9069	PeptideMeter	2026-Q2	98.32	7.36	—	Buyer-sourced	0	PASS
AX-2026-043237	SLU-PP-332	SGN-2602-X9377	Janoshik	2026-Q2	98.47	6.22	100.0	Supplier-supplied	0	PASS
AX-2026-043227	ARA-290	SGN-2605-X9069	PeptideMeter	2026-Q2	98.38	7.21	95.6	Buyer-sourced	0	PASS
AX-2026-043239	SLU-PP-332	SGN-2602-X9377	VendorInvestigate	2026-Q2	98.28	5.37	—	Buyer-sourced	0	PASS
AX-2026-043229	ARA-290	SGN-2605-X9069	Janoshik	2026-Q2	98.21	7.43	—	Buyer-sourced	0	PASS