AssayIndex

HYB-2409-X6061

BPC-157 · 2 mg declared · Shenzhen Hybio Pharmaceutical Co., Ltd. · manufactured 14 Sep 2024

CHARACTERISED
Lot code
HYB-2409-X6061
Supplier
HYB — Shenzhen Hybio Pharmaceutical Co., Ltd.
Compound
BPC-157
Compound class
Tissue-repair and immunomodulatory peptides
Declared label claim
2mg
Manufacture date
14 Sep 2024
Index quarter
2024-Q4
Independent assays
11
Laboratories involved
Janoshik, PeptideMeter, Medutest, VendorInvestigate, Nordanalyt
Provenance mix
Buyer-sourced ×10 · 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 11
Median purity 99.30% n=11
Spread (max − min) 0.65pp n=11
Standard deviation 0.214pp n=11
97.097.598.098.699.199.6100.1This lot (HYB-2409-X6061)This lot (HYB-2409-X6061): Q1 99.16, median 99.30, Q3 99.47, n=11n=11All BPC-157All BPC-157: Q1 98.71, median 99.16, Q3 99.68, n=510outlier 97.20n=510 Purity (% area)
Figure 1. This lot's independent purity results against the whole BPC-157 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 11

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-2024-004477HYB-2409-X6061Janoshik2024-Q498.953.58100.7Buyer-sourced1MARGINAL
AX-2024-004478HYB-2409-X6061PeptideMeter2024-Q499.173.3690.5Buyer-sourced1MARGINAL
AX-2024-004479HYB-2409-X6061Medutest2024-Q499.544.32104.4Buyer-sourced1MARGINAL
AX-2024-004480HYB-2409-X6061VendorInvestigate2024-Q499.593.42Buyer-sourced1MARGINAL
AX-2024-004481HYB-2409-X6061Janoshik2024-Q499.293.8688.5Buyer-sourced2MARGINAL
AX-2024-004482HYB-2409-X6061Nordanalyt2024-Q499.403.53Buyer-sourced1MARGINAL
AX-2024-004483HYB-2409-X6061Nordanalyt2024-Q499.303.7994.3Buyer-sourced1MARGINAL
AX-2025-019339HYB-2409-X6061PeptideMeter2024-Q499.073.80106.2Buyer-sourced1MARGINAL
AX-2024-004484HYB-2409-X6061Nordanalyt2024-Q499.304.0389.1Laboratory-retained2MARGINAL
AX-2024-004485HYB-2409-X6061Janoshik2024-Q499.143.78Buyer-sourced2MARGINAL
AX-2024-004486HYB-2409-X6061Medutest2024-Q499.603.40Buyer-sourced1MARGINAL
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
Janoshik398.95, 99.29, 99.1499.1430min+0.0099.14
PeptideMeter299.17, 99.0799.1228min-0.0599.17
Medutest299.54, 99.6099.5725min+0.0899.49
VendorInvestigate199.5999.5932min-0.1199.70
Nordanalyt399.40, 99.30, 99.3099.3035min+0.0299.28

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)99.098.95divergence -0.30 pp vs batch median
Total impurities (% area)1.001.05
Largest single impurity (% area)0.600.41
Water (%)not stated3.58
Counter-ion (%)not stated8.80
Peptide content (%w/w)not stated86.97
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
pyroglutamate cyclisation (−17 Da)11 / 110.270.03–0.41
des-Gly truncate (−57 Da)11 / 110.180.04–0.56
[D-Val]-diastereomer10 / 110.060.02–0.37
truncated (1-12)9 / 110.100.03–0.16
BPC-157 arginine-salt artefact6 / 110.030.03–0.05
acetylated N-terminus (+42 Da)5 / 110.110.03–0.12
Section 7

What this rollup does not establish