WWB-2403-J3152

Tirzepatide · 30 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · manufactured 20 Mar 2024

CHARACTERISED

Lot code: WWB-2403-J3152
Supplier: WWB — Wuhan Wansheng Biotechnology Co., Ltd.
Compound: Tirzepatide
Compound class: Incretin analogues and co-agonists
Declared label claim: 30mg
Manufacture date: 20 Mar 2024
Index quarter: 2024-Q3
Independent assays: 10
Laboratories involved: Medutest, Janoshik, PeptideMeter, VendorInvestigate, Nordanalyt
Provenance mix: Buyer-sourced ×1 · Supplier-supplied ×8 · 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 98.34% n=10

Spread (max − min) 0.91pp n=10

Standard deviation 0.261pp n=10

Figure 1. This lot's independent purity results against the whole Tirzepatide record set in the index. The vertical line is the index acceptance specification for the incretin analogues and co-agonists class, 97.0 % 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	Flags	Result
AX-2024-004161	WWB-2403-J3152	Medutest	2024-Q3	98.15	3.36	—	Supplier-supplied	2	MARGINAL
AX-2024-004162	WWB-2403-J3152	Janoshik	2024-Q3	98.79	3.43	94.5	Supplier-supplied	2	MARGINAL
AX-2024-004163	WWB-2403-J3152	Janoshik	2024-Q3	98.27	3.28	99.2	Supplier-supplied	2	MARGINAL
AX-2024-004164	WWB-2403-J3152	PeptideMeter	2024-Q3	97.88	3.47	107.0	Supplier-supplied	2	MARGINAL
AX-2024-004165	WWB-2403-J3152	PeptideMeter	2024-Q3	98.39	3.71	—	Supplier-supplied	2	MARGINAL
AX-2024-004166	WWB-2403-J3152	VendorInvestigate	2024-Q3	98.11	3.43	—	Buyer-sourced	2	MARGINAL
AX-2024-004167	WWB-2403-J3152	PeptideMeter	2024-Q3	98.51	3.64	—	Supplier-supplied	2	MARGINAL
AX-2024-004168	WWB-2403-J3152	Janoshik	2024-Q3	98.39	3.46	101.3	Supplier-supplied	3	FAIL
AX-2024-004169	WWB-2403-J3152	Nordanalyt	2024-Q3	98.60	3.87	93.4	Laboratory-retained	2	MARGINAL
AX-2024-004170	WWB-2403-J3152	Janoshik	2024-Q3	98.29	3.09	—	Supplier-supplied	2	MARGINAL

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
Medutest	1	98.15	98.15	25min	+0.08	98.07
Janoshik	4	98.79, 98.27, 98.39, 98.29	98.34	30min	+0.00	98.34
PeptideMeter	3	97.88, 98.39, 98.51	98.39	28min	-0.05	98.44
VendorInvestigate	1	98.11	98.11	32min	-0.11	98.22
Nordanalyt	1	98.60	98.60	35min	+0.02	98.58

This lot contributes 10 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)	99.01	98.15	divergence +0.67 pp vs batch median
Total impurities (% area)	0.99	1.85
Largest single impurity (% area)	0.56	0.67
Water (%)	1.4	3.36
Counter-ion (%)	7.2	6.16
Peptide content (%w/w)	90.8	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-Aib2 analogue	10 / 10	0.27	0.02–0.67
Met(O) sulfoxide (+16 Da)	10 / 10	0.37	0.22–0.48
trifluoroacetyl adduct (+96 Da)	10 / 10	0.23	0.07–0.46
[D-Aib13]-diastereomer	10 / 10	0.30	0.13–0.76
C20 diacid mono-amide	10 / 10	0.24	0.04–0.75
des-Gly deletion (−57 Da)	10 / 10	0.03	0.02–0.07

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