AssayIndex

ERP-2509-K7351

PEG-MGF · 5 mg declared · Shanghai ERP Biotechnology Co., Ltd. · manufactured 22 Sep 2025

CHARACTERISED
Lot code
ERP-2509-K7351
Supplier
ERP — Shanghai ERP Biotechnology Co., Ltd.
Compound
PEG-MGF
Compound class
Growth-hormone axis peptides
Declared label claim
5mg
Manufacture date
22 Sep 2025
Index quarter
2026-Q1
Independent assays
5
Laboratories involved
Janoshik, Kestrel
Provenance mix
Buyer-sourced ×4 · Supplier-supplied ×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 5
Median purity 98.16% n=5
Spread (max − min) 1.56pp n=5
Standard deviation 0.620pp n=5
95.496.096.697.397.998.599.2This lot (ERP-2509-K7351)This lot (ERP-2509-K7351): Q1 98.01, median 98.16, Q3 98.73, n=5n=5All PEG-MGFAll PEG-MGF: Q1 96.55, median 97.89, Q3 98.20, n=20n=20 Purity (% area)
Figure 1. This lot's independent purity results against the whole PEG-MGF record set in the index. The vertical line is the index acceptance specification for the growth-hormone axis peptides class, 92.0 % 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 5

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

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042658ERP-2509-K7351Janoshik2026-Q198.925.4493.1Supplier-supplied1MARGINAL
AX-2026-042659ERP-2509-K7351Janoshik2026-Q198.165.77—Buyer-sourced0PASS
AX-2026-042660ERP-2509-K7351Janoshik2026-Q197.365.21—Buyer-sourced0PASS
AX-2026-042661ERP-2509-K7351Janoshik2026-Q198.015.06—Buyer-sourced0PASS
AX-2026-042662ERP-2509-K7351Kestrel2026-Q198.735.4096.0Buyer-sourced0PASS
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.

LaboratoryReportsPurity results (% area)MedianGradientPublished bias (pp)Bias-adjusted
Janoshik498.92, 98.16, 97.36, 98.0198.0930min+0.0098.09
Kestrel198.7398.7315min+0.2498.49

This lot contributes 1 paired comparison 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.

FigureSupplier COAThis reportIndex note
Purity (% area)98.3198.92divergence +0.15 pp vs batch median
Total impurities (% area)1.691.08
Largest single impurity (% area)1.180.56
Water (%)not stated5.44
Counter-ion (%)not stated2.02
Peptide content (%w/w)not stated91.55
Endotoxin (EU/mg)0.19not determined
Method stated on certificateNO—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 impurityReported inMedian % areaRange
free MGF (unconjugated)5 / 50.560.15–1.37
free mPEG5 / 50.280.12–0.69
di-PEGylated species5 / 50.290.12–0.64
hydrolysed linker5 / 50.290.12–1.06
Section 7

What this rollup does not establish