AssayIndex

HYB-2403-B4304

ARA-290 · 10 mg declared · Shenzhen Hybio Pharmaceutical Co., Ltd. · manufactured 24 Mar 2024

CHARACTERISED
Lot code
HYB-2403-B4304
Supplier
HYB — Shenzhen Hybio Pharmaceutical Co., Ltd.
Compound
ARA-290
Compound class
Tissue-repair and immunomodulatory peptides
Declared label claim
10mg
Manufacture date
24 Mar 2024
Index quarter
2024-Q3
Independent assays
5
Laboratories involved
Medutest, VendorInvestigate, PeptideMeter, Nordanalyt, Janoshik
Provenance mix
Buyer-sourced ×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 99.60% n=5
Spread (max − min) 0.63pp n=5
Standard deviation 0.283pp n=5
97.798.198.598.999.399.7100.1This lot (HYB-2403-B4304)This lot (HYB-2403-B4304): Q1 99.25, median 99.60, Q3 99.69, n=5n=5All ARA-290All ARA-290: Q1 99.17, median 99.64, Q3 99.90, n=73outlier 97.90outlier 98.00outlier 98.05outlier 98.07n=73 Purity (% area)
Figure 1. This lot's independent purity results against the whole ARA-290 record set in the index. The vertical line is the index acceptance specification for the tissue-repair and immunomodulatory peptides class, 98.0 % 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-2024-004620HYB-2403-B4304Medutest2024-Q399.256.8696.2Buyer-sourced0PASS
AX-2024-004621HYB-2403-B4304VendorInvestigate2024-Q399.097.44Buyer-sourced0PASS
AX-2024-004622HYB-2403-B4304PeptideMeter2024-Q399.697.21106.4Buyer-sourced0PASS
AX-2024-004623HYB-2403-B4304Nordanalyt2024-Q399.727.4093.6Buyer-sourced0PASS
AX-2024-004624HYB-2403-B4304Janoshik2024-Q399.606.85Buyer-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
Medutest199.2599.2525min+0.0899.17
VendorInvestigate199.0999.0932min-0.1199.20
PeptideMeter199.6999.6928min-0.0599.74
Nordanalyt199.7299.7235min+0.0299.70
Janoshik199.6099.6030min+0.0099.60

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.

FigureSupplier COAThis reportIndex note
Purity (% area)99.4399.25divergence -0.17 pp vs batch median
Total impurities (% area)0.570.75
Largest single impurity (% area)0.250.31
Water (%)6.86.86
Counter-ion (%)not stated4.50
Peptide content (%w/w)not stated87.84
Endotoxin (EU/mg)not statednot determined
Method stated on certificateYEScolumn, 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 impurityReported inMedian % areaRange
des-Gln truncate (−128 Da)5 / 50.170.13–0.53
deamidated (+1 Da)5 / 50.100.03–0.25
acetyl adduct (+42 Da)5 / 50.060.05–0.19
[D-Ser]-diastereomer5 / 50.040.03–0.10
Section 7

What this rollup does not establish