HYB-2603-U4136

Epitalon · 10 mg declared · Shenzhen Hybio Pharmaceutical Co., Ltd. · manufactured 16 Mar 2026

CHARACTERISED

Lot code: HYB-2603-U4136
Supplier: HYB — Shenzhen Hybio Pharmaceutical Co., Ltd.
Compound: Epitalon
Compound class: Short bioregulator peptides
Declared label claim: 10mg
Manufacture date: 16 Mar 2026
Index quarter: 2026-Q2
Independent assays: 10
Laboratories involved: Kestrel, Nordanalyt, Medutest, Janoshik
Provenance mix: Buyer-sourced ×9 · Laboratory-retained ×1

Section 1

Reproducibility across independent tests

Every report below is an observation of the same physical material. What they disagree about is measurement; what they agree about is the lot. The size of the disagreement is compared against what the contributing laboratories' own repeatability figures predict.

Independent assays 10

Median purity 99.70% n=10

Spread (max − min) 0.72pp n=10

Standard deviation 0.226pp n=10

Figure 1. This lot's independent purity results against the whole Epitalon record set in the index. The vertical line is the index acceptance specification for the short bioregulator peptides class, 99.0 % area. A narrow box on the top row against a wide box on the bottom row is the ideal reading: it means the disagreement between lots is much larger than the disagreement within this one.

Section 2

Member reports 10

Every report the index holds on this lot. Each is a page carrying its own chromatogram, mass spectrum, mass balance, provenance and caveats.

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-041901	HYB-2603-U4136	Kestrel	2026-Q2	99.93	6.07	100.9	Buyer-sourced	PASS
AX-2026-041902	HYB-2603-U4136	Nordanalyt	2026-Q2	99.85	6.70	101.6	Buyer-sourced	FAIL
AX-2026-041903	HYB-2603-U4136	Medutest	2026-Q2	99.77	7.18	—	Laboratory-retained	PASS
AX-2026-041904	HYB-2603-U4136	Janoshik	2026-Q2	99.21	6.73	91.9	Buyer-sourced	PASS
AX-2026-041905	HYB-2603-U4136	Kestrel	2026-Q2	99.58	6.33	—	Buyer-sourced	PASS
AX-2026-041906	HYB-2603-U4136	Nordanalyt	2026-Q2	99.57	6.24	106.4	Buyer-sourced	FAIL
AX-2026-041907	HYB-2603-U4136	Medutest	2026-Q2	99.93	7.09	91.5	Buyer-sourced	FAIL
AX-2026-041908	HYB-2603-U4136	Janoshik	2026-Q2	99.62	7.00	—	Buyer-sourced	FAIL
AX-2026-041909	HYB-2603-U4136	Janoshik	2026-Q2	99.51	7.09	100.7	Buyer-sourced	FAIL
AX-2026-041910	HYB-2603-U4136	Kestrel	2026-Q2	99.83	6.78	101.3	Buyer-sourced	FAIL

Section 3

By laboratory

Where more than one laboratory assayed this lot, the difference between them is a paired observation of their relative bias — the same material, the same time window, different instruments. Those pairs are what the index's bias estimates are built from.

Laboratory	Reports	Purity results (% area)	Median	Gradient	Published bias (pp)	Bias-adjusted
Kestrel	3	99.93, 99.58, 99.83	99.83	15min	+0.24	99.59
Nordanalyt	2	99.85, 99.57	99.71	35min	+0.02	99.69
Medutest	2	99.77, 99.93	99.85	25min	+0.08	99.77
Janoshik	3	99.21, 99.62, 99.51	99.51	30min	+0.00	99.51

This lot contributes 6 paired comparisons to the inter-lab analysis.

Section 4

The supplier's certificate for this lot

One number the supplier wrote, beside the median of the numbers other people measured on the same physical material. That comparison is only available because the index groups by lot.

Figure	Supplier COA	This report	Index note
Purity (% area)	99.90	99.93	divergence +0.20 pp vs batch median
Total impurities (% area)	0.10	0.07
Largest single impurity (% area)	0.07	0.04
Water (%)	not stated	6.07
Counter-ion (%)	not stated	8.96
Peptide content (%w/w)	not stated	84.55
Endotoxin (EU/mg)	not stated	not determined
Method stated on certificate	YES	—	column, gradient and wavelength given

Section 5

Impurity fingerprint

The named impurities reported across this lot's assays, with how consistently each was seen. A fingerprint is what allows two lot numbers held by different companies to be identified as one bulk.

Named impurity	Reported in	Median % area	Range
aspartimide (−18 Da)	10 / 10	0.05	0.03–0.11
Ala-Glu-Asp tripeptide (−57 Da)	8 / 10	0.04	0.03–0.35
β-Asp isomer	8 / 10	0.11	0.02–0.29
diketopiperazine (−18 Da)	7 / 10	0.03	0.02–0.33

Section 7

Reproducibility across independent tests

Member reports 10

By laboratory

The supplier's certificate for this lot

Impurity fingerprint

What this rollup does not establish