AssayIndex

SSA-2410-G6381

Semax · 5 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · manufactured 12 Oct 2024

CHARACTERISED
Lot code
SSA-2410-G6381
Supplier
SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Compound
Semax
Compound class
Neuroactive and cognitive peptides
Declared label claim
5mg
Manufacture date
12 Oct 2024
Index quarter
2024-Q4
Independent assays
9
Laboratories involved
VendorInvestigate, Nordanalyt, Medutest, PeptideMeter
Provenance mix
Buyer-sourced ×3 · Supplier-supplied ×5 · 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 9
Median purity 98.30% n=9
Spread (max − min) 1.13pp n=9
Standard deviation 0.323pp n=9
97.698.098.598.999.399.7100.1This lot (SSA-2410-G6381)This lot (SSA-2410-G6381): Q1 98.19, median 98.30, Q3 98.38, n=9outlier 99.12n=9All SemaxAll Semax: Q1 98.65, median 99.17, Q3 99.63, n=160n=160 Purity (% area)
Figure 1. This lot's independent purity results against the whole Semax record set in the index. The vertical line is the index acceptance specification for the neuroactive and cognitive peptides 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 9

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-2024-005203SSA-2410-G6381VendorInvestigate2024-Q497.9910.1394.9Buyer-sourced0FAIL
AX-2024-005204SSA-2410-G6381Nordanalyt2024-Q498.1910.33100.9Laboratory-retained0FAIL
AX-2024-005205SSA-2410-G6381VendorInvestigate2024-Q498.309.40100.9Buyer-sourced0FAIL
AX-2024-005206SSA-2410-G6381Medutest2024-Q499.129.90Supplier-supplied0PASS
AX-2024-005207SSA-2410-G6381Nordanalyt2024-Q498.349.40Supplier-supplied0FAIL
AX-2024-005208SSA-2410-G6381PeptideMeter2024-Q498.1910.68106.6Supplier-supplied0FAIL
AX-2024-005209SSA-2410-G6381PeptideMeter2024-Q498.1510.0999.7Supplier-supplied0FAIL
AX-2024-005210SSA-2410-G6381Medutest2024-Q498.499.72106.2Supplier-supplied0FAIL
AX-2024-005211SSA-2410-G6381VendorInvestigate2024-Q498.3810.0295.9Buyer-sourced1FAIL
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
VendorInvestigate397.99, 98.30, 98.3898.3032min-0.1198.41
Nordanalyt298.19, 98.3498.2735min+0.0298.25
Medutest299.12, 98.4998.8125min+0.0898.73
PeptideMeter298.19, 98.1598.1728min-0.0598.22

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)98.6097.99divergence +0.30 pp vs batch median
Total impurities (% area)1.402.01
Largest single impurity (% area)not stated1.11
Water (%)not stated10.13
Counter-ion (%)not stated5.82
Peptide content (%w/w)not stated83.03
Endotoxin (EU/mg)not stated0.30
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
Met1 sulfoxide (+16 Da)9 / 90.900.19–1.11
des-Met (−131 Da)9 / 90.360.07–0.45
N-acetyl semax (+42 Da)9 / 90.180.06–0.23
diketopiperazine (−18 Da)9 / 90.220.18–1.15
Section 7

What this rollup does not establish