AssayIndex

SSA-2401-E8185

BPC-157 · 2 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · manufactured 26 Jan 2024

CHARACTERISED
Lot code
SSA-2401-E8185
Supplier
SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Compound
BPC-157
Compound class
Tissue-repair and immunomodulatory peptides
Declared label claim
2mg
Manufacture date
26 Jan 2024
Index quarter
2024-Q2
Independent assays
5
Laboratories involved
Medutest, Janoshik, Kestrel, PeptideMeter
Provenance mix
Buyer-sourced ×1 · Supplier-supplied ×4
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 99.61% n=5
Spread (max − min) 0.64pp n=5
Standard deviation 0.256pp n=5
96.897.397.998.599.099.6100.2This lot (SSA-2401-E8185)This lot (SSA-2401-E8185): Q1 99.55, median 99.61, Q3 99.66, n=5outlier 99.08n=5All BPC-157All BPC-157: Q1 98.59, median 99.15, Q3 99.71, n=591n=591 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 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-2024-005273SSA-2401-E8185Medutest2024-Q299.725.2993.0Supplier-supplied0PASS
AX-2024-005274SSA-2401-E8185Janoshik2024-Q299.085.77Buyer-sourced1MARGINAL
AX-2024-005275SSA-2401-E8185Kestrel2024-Q299.614.6892.3Supplier-supplied1MARGINAL
AX-2024-005276SSA-2401-E8185Medutest2024-Q299.665.0890.8Supplier-supplied1MARGINAL
AX-2024-005277SSA-2401-E8185PeptideMeter2024-Q299.555.1293.5Supplier-supplied0PASS
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
Medutest299.72, 99.6699.6925min+0.0899.61
Janoshik199.0899.0830min+0.0099.08
Kestrel199.6199.6115min+0.2499.37
PeptideMeter199.5599.5528min-0.0599.60

This lot contributes 6 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)99.8799.72divergence +0.26 pp vs batch median
Total impurities (% area)0.130.28
Largest single impurity (% area)not stated0.11
Water (%)not stated5.29
Counter-ion (%)not stated7.06
Peptide content (%w/w)not stated86.73
Endotoxin (EU/mg)0.50not 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-Gly truncate (−57 Da)5 / 50.130.09–0.29
pyroglutamate cyclisation (−17 Da)5 / 50.060.04–0.50
truncated (1-12)4 / 50.140.03–0.18
BPC-157 arginine-salt artefact3 / 50.050.04–0.06
[D-Val]-diastereomer2 / 50.060.06–0.06
acetylated N-terminus (+42 Da)2 / 50.040.03–0.04
Section 7

What this rollup does not establish