AssayIndex

WXT-2411-H3906

Sermorelin · 10 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · manufactured 25 Nov 2024

CHARACTERISED
Lot code
WXT-2411-H3906
Supplier
WXT — WuXi TIDES (WuXi AppTec Testing Division)
Compound
Sermorelin
Compound class
Growth-hormone axis peptides
Declared label claim
10mg
Manufacture date
25 Nov 2024
Index quarter
2025-Q1
Independent assays
4
Laboratories involved
Nordanalyt, Medutest, Janoshik
Provenance mix
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 4
Median purity 97.84% n=4
Spread (max − min) 0.69pp n=4
Standard deviation 0.311pp n=4
97.497.898.398.799.199.6100.0This lot (WXT-2411-H3906)This lot (WXT-2411-H3906): Q1 97.66, median 97.84, Q3 98.06, n=4n=4All SermorelinAll Sermorelin: Q1 98.39, median 98.94, Q3 99.22, n=96n=96 Purity (% area)
Figure 1. This lot's independent purity results against the whole Sermorelin record set in the index. The vertical line is the index acceptance specification for the growth-hormone axis 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 4

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-2025-021040WXT-2411-H3906Nordanalyt2025-Q197.995.57Supplier-supplied2FAIL
AX-2025-021041WXT-2411-H3906Medutest2025-Q197.585.90Supplier-supplied1FAIL
AX-2025-021042WXT-2411-H3906Janoshik2025-Q198.275.70Supplier-supplied1MARGINAL
AX-2025-021043WXT-2411-H3906Janoshik2025-Q197.696.4389.6Supplier-supplied2FAIL
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
Nordanalyt197.9997.9935min+0.0297.97
Medutest197.5897.5825min+0.0897.50
Janoshik298.27, 97.6997.9830min+0.0097.98

This lot contributes 3 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)97.7897.99divergence -0.06 pp vs batch median
Total impurities (% area)1.382.01
Largest single impurity (% area)0.850.88
Water (%)not stated5.57
Counter-ion (%)not stated3.78
Peptide content (%w/w)not statednot determined
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
deamidated Asn8 (+1 Da)4 / 41.200.76–1.59
des-Tyr1 (−163 Da)4 / 40.430.21–0.74
aspartimide (−18 Da)4 / 40.260.17–0.34
truncated (1-25)4 / 40.230.16–0.27
Section 7

What this rollup does not establish