AX-2024-005547

Tirzepatide · 10 mg declared · Qingdao Saber Technology Pharmaceutical · lot QST-2409-K8302

MARGINALPURITY ONLY

Report ID: AX-2024-005547
Compound: Tirzepatide
Compound class: Incretin analogues and co-agonists
Supplier: QST — Qingdao Saber Technology Pharmaceutical
Batch / lot: QST-2409-K8302
Declared label claim: 10mg
Laboratory: Janoshik Analytical
Assay date: 24 Dec 2024
Submitted: 27 Dec 2024
Quarter: 2024-Q4
Submitter: a.duarte
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, 30 min gradient, 214 nm	98.65	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.35	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — des-Aib2 analogue	0.85	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	84.37	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	83.23	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	11.65	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	9.696	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	97.0	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	6.83	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	8.19	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.61	%	—	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	3.74	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	19.79	min	19.86 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.14	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	51,915	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib13]-diastereomer	0.53	—	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 51,915, and skew follows the reported asymmetry factor of 1.14. 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 0.85 % impurity against a 98.65 % 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	19.79	4,794,696	98.65	—
2	des-Aib2 analogue	19.44	41,313	0.85	-85.053
3	C20 diacid mono-amide	21.41	16,039	0.33	+0.984
4	des-Gly deletion (−57 Da)	19.18	4,374	0.09	-57.021
5	[D-Aib13]-diastereomer	19.60	2,916	0.06	0.000
6	Met(O) sulfoxide (+16 Da)	19.05	486	0.01	+15.995
7	truncated (3-39)	18.31	486	0.01	-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.

Component	Determination	%w/w of cake
Water	Karl Fischer	6.83
Counter-ion (TFA)	ion chromatography	8.19
Residual solvent + inorganic residue	estimated	0.61
Total peptide content	by difference	84.37
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)	98.41	98.65	divergence -0.05 pp vs batch median
Total impurities (% area)	not stated	1.35
Largest single impurity (% area)	not stated	0.85
Water (%)	not stated	6.83
Counter-ion (%)	not stated	8.19
Peptide content (%w/w)	not stated	84.37
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, 4 d) → assay. Submitter did not handle the vial.
Assay date: 24 Dec 2024
Submitted to the index: 27 Dec 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: PURITY ONLY

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 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 QST-2409-K8302 n=2

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005548	QST-2409-K8302	Janoshik	2024-Q4	98.26	6.11	95.0	Supplier-supplied	1	MARGINAL

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 QST records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043586	MOTS-c	QST-2511-H7867	PeptideMeter	2026-Q2	98.06	5.19	97.7	Supplier-supplied	0	PASS
AX-2026-043585	GHRP-6	QST-2508-M7961	Janoshik	2026-Q1	98.52	6.05	93.3	Supplier-supplied	1	FAIL
AX-2024-005548	Tirzepatide	QST-2409-K8302	Janoshik	2024-Q4	98.26	6.11	95.0	Supplier-supplied	1	MARGINAL
AX-2024-005545	NAD+	QST-2402-B8115	Kestrel	2024-Q3	98.37	8.65	—	Supplier-supplied	1	FAIL
AX-2024-005542	NAD+	QST-2402-B8115	PeptideMeter	2024-Q3	97.66	8.82	104.3	Buyer-sourced	0	PASS
AX-2024-005546	NAD+	QST-2402-B8115	Janoshik	2024-Q3	98.80	8.87	—	Supplier-supplied	1	FAIL
AX-2024-005543	NAD+	QST-2402-B8115	Nordanalyt	2024-Q3	98.39	8.83	107.2	Supplier-supplied	0	PASS
AX-2024-005541	NAD+	QST-2402-B8115	Nordanalyt	2024-Q3	97.56	8.60	—	Supplier-supplied	0	PASS