AssayIndex

ERP-2503-A7432

Oxytocin · 10 mg declared · Shanghai ERP Biotechnology Co., Ltd. · manufactured 15 Mar 2025

CHARACTERISED
Lot code
ERP-2503-A7432
Supplier
ERP — Shanghai ERP Biotechnology Co., Ltd.
Compound
Oxytocin
Compound class
Hypothalamic and posterior-pituitary hormones
Declared label claim
10mg
Manufacture date
15 Mar 2025
Index quarter
2025-Q2
Independent assays
5
Laboratories involved
Janoshik, Nordanalyt
Provenance mix
Supplier-supplied ×5
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 98.82% n=5
Spread (max − min) 0.74pp n=5
Standard deviation 0.359pp n=5
98.698.999.199.399.699.8100.0This lot (ERP-2503-A7432)This lot (ERP-2503-A7432): Q1 98.81, median 98.82, Q3 99.41, n=5n=5All OxytocinAll Oxytocin: Q1 99.42, median 99.57, Q3 99.93, n=14n=14 Purity (% area)
Figure 1. This lot's independent purity results against the whole Oxytocin record set in the index. The vertical line is the index acceptance specification for the hypothalamic and posterior-pituitary hormones class, 98.5 % 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 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-2025-020052ERP-2503-A7432Janoshik2025-Q299.415.45Supplier-supplied1MARGINAL
AX-2025-020053ERP-2503-A7432Janoshik2025-Q299.464.8493.5Supplier-supplied1MARGINAL
AX-2025-020054ERP-2503-A7432Janoshik2025-Q298.724.96Supplier-supplied1MARGINAL
AX-2025-020055ERP-2503-A7432Janoshik2025-Q298.824.60Supplier-supplied1MARGINAL
AX-2025-020056ERP-2503-A7432Nordanalyt2025-Q298.815.01Supplier-supplied1MARGINAL
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
Janoshik499.41, 99.46, 98.72, 98.8299.1130min+0.0099.11
Nordanalyt198.8198.8135min+0.0298.79

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)99.599.41divergence +0.68 pp vs batch median
Total impurities (% area)0.500.59
Largest single impurity (% area)not stated0.37
Water (%)2.55.45
Counter-ion (%)8.15.35
Peptide content (%w/w)88.8not determined
Endotoxin (EU/mg)not statednot determined
Method stated on certificateNOno 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
open-chain (reduced disulfide, +2 Da)5 / 50.370.07–0.83
deamidated Gln4 (+1 Da)5 / 50.240.14–0.30
des-Gly9 (−57 Da)5 / 50.080.05–0.09
oxytocin dimer (intermolecular disulfide)4 / 50.060.03–0.07
Tyr sulfoxide artefact (+16 Da)4 / 50.160.04–0.57
Section 7

What this rollup does not establish