AX-2025-019364

Tirzepatide · 15 mg declared · Shenzhen Hybio Pharmaceutical Co., Ltd. · lot HYB-2408-R7015

MARGINALPURITY ONLY

Report ID: AX-2025-019364
Compound: Tirzepatide
Compound class: Incretin analogues and co-agonists
Supplier: HYB — Shenzhen Hybio Pharmaceutical Co., Ltd.
Batch / lot: HYB-2408-R7015
Declared label claim: 15mg
Laboratory: Janoshik Analytical
Assay date: 07 Mar 2025
Submitted: 12 Mar 2025
Quarter: 2025-Q1
Submitter: third_opinion
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	98.30	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.70	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — C20 diacid mono-amide	0.67	% 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	85.08	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	83.63	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	16.11	mg	15 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	13.473	mg	15 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	89.8	%	90.0 – 110.0	FAIL
Water content	Karl Fischer, coulometric, duplicate	5.23	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	9.07	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.62	%	—	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 cake, partial shrinkage from vial wall	—	white to off-white intact cake	FAIL
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	3.26	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	19.73	min	19.86 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.46	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	44,118	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib13]-diastereomer	0.49	—	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 44,118, and skew follows the reported asymmetry factor of 1.46. 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 0.67 % impurity against a 98.30 % 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	19.73	4,777,685	98.30	—
2	C20 diacid mono-amide	21.35	32,564	0.67	+0.984
3	[D-Aib13]-diastereomer	19.54	30,620	0.63	0.000
4	Met(O) sulfoxide (+16 Da)	18.99	13,123	0.27	+15.995
5	trifluoroacetyl adduct (+96 Da)	20.66	2,916	0.06	+95.982
6	tirzepatide dimer	23.71	1,944	0.04	+4810.410
7	truncated (3-39)	18.25	1,458	0.03	-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	5.23
Counter-ion (TFA)	ion chromatography	9.07
Residual solvent + inorganic residue	estimated	0.62
Total peptide content	by difference	85.08
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)	98.81	98.30	divergence +0.51 pp vs batch median
Total impurities (% area)	1.19	1.70
Largest single impurity (% area)	not stated	0.67
Water (%)	3.1	5.23
Counter-ion (%)	not stated	9.07
Peptide content (%w/w)	not stated	85.08
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 (ambient, 29 d) → laboratory (hand-carried, 7 d) → assay.
Assay date: 07 Mar 2025
Submitted to the index: 12 Mar 2025
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 3

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.

lot_traceability12 Mar 2025

A retail vial at 98.30 % is worth more evidentially than a selected vial at a higher figure. That is the whole argument for recording provenance at all.

valley_drop12 Mar 2025

The reported figure derives from the plate count and the retention gap, via the pharmacopoeial form with the sum of both peak widths in the denominator. It is a calculated quantity, not a measured one, and it inherits the plate count's uncertainty.

price_per_mg12 Mar 2025

The comparison that matters is cost per milligram of recovered peptide, not cost per vial. On this lot the two differ by about a sixth.

Section 7

Related records

Same batch — lot HYB-2408-R7015 n=5

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2025-019362	HYB-2408-R7015	Janoshik	2025-Q1	98.47	5.77	97.8	Buyer-sourced	PASS
AX-2025-019363	HYB-2408-R7015	Janoshik	2025-Q1	98.42	4.63	106.8	Buyer-sourced	PASS
AX-2025-019365	HYB-2408-R7015	Janoshik	2025-Q1	98.08	5.63	100.2	Buyer-sourced	PASS
AX-2025-019366	HYB-2408-R7015	PeptideMeter	2025-Q1	97.98	5.63	94.9	Buyer-sourced	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 HYB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042083	MOTS-c	HYB-2606-D7858	Medutest	2026-Q3	99.93	2.02	—	Buyer-sourced	0	PASS
AX-2026-042090	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.57	2.36	—	Buyer-sourced	1	FAIL
AX-2026-042084	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.28	2.79	107.3	Buyer-sourced	0	PASS
AX-2026-042087	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.54	3.05	—	Buyer-sourced	0	PASS
AX-2026-042085	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.51	2.31	—	Buyer-sourced	0	PASS
AX-2026-042088	MOTS-c	HYB-2606-D7858	PeptideMeter	2026-Q3	99.22	2.21	—	Buyer-sourced	0	PASS
AX-2026-042086	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.93	3.02	—	Buyer-sourced	1	MARGINAL
AX-2026-042091	CJC-1295 with DAC	HYB-2608-E7391	Janoshik	2026-Q3	99.38	5.53	—	Buyer-sourced	0	PASS