ERP-2601-P7653

Liraglutide · 10 mg declared · Shanghai ERP Biotechnology Co., Ltd. · manufactured 15 Jan 2026

PARTIALLY CHARACTERISED

Lot code: ERP-2601-P7653
Supplier: ERP — Shanghai ERP Biotechnology Co., Ltd.
Compound: Liraglutide
Compound class: Incretin analogues and co-agonists
Declared label claim: 10mg
Manufacture date: 15 Jan 2026
Index quarter: 2026-Q2
Independent assays: 2
Laboratories involved: Janoshik
Provenance mix: Buyer-sourced ×2

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 2

Median purity 98.51% n=2

Spread (max − min) 0.03pp n=2

Standard deviation n<3 n=2

Figure 1. This lot's independent purity results against the whole Liraglutide record set in the index. The vertical line is the index acceptance specification for the incretin analogues and co-agonists class, 97.5 % 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 2

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	Flags	Result
AX-2026-042656	ERP-2601-P7653	Janoshik	2026-Q2	98.49	4.49	—	Buyer-sourced	2	MARGINAL
AX-2026-042657	ERP-2601-P7653	Janoshik	2026-Q2	98.52	5.19	95.2	Buyer-sourced	2	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
Janoshik	2	98.49, 98.52	98.50	30min	+0.00	98.50

A single laboratory assayed this lot, so it contributes no paired comparison and the bias-adjusted column is a subtraction rather than a measurement.

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)	98.5	98.49	divergence -0.01 pp vs batch median
Total impurities (% area)	not stated	1.51
Largest single impurity (% area)	not stated	0.97
Water (%)	2.8	4.49
Counter-ion (%)	6.2	6.89
Peptide content (%w/w)	96.3	not determined
Endotoxin (EU/mg)	not stated	not determined
Method stated on certificate	NO	—	no method section — the result cannot be reconciled against any other

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
des-palmitoyl liraglutide (−238 Da)	2 / 2	0.49	0.02–0.97
des-His1 truncate (−137 Da)	2 / 2	0.20	0.13–0.26
deamidated (Asn→Asp, +1 Da)	2 / 2	0.60	0.17–1.03
γ-Glu regioisomer	2 / 2	0.16	0.08–0.25
palmitoyl bis-adduct (+238 Da)	2 / 2	0.03	0.02–0.04
liraglutide dimer	2 / 2	0.01	0.01–0.01

Section 7

Reproducibility across independent tests

Member reports 2

By laboratory

The supplier's certificate for this lot

Impurity fingerprint

What this rollup does not establish