AssayIndex

GGPE-2409-C8719

Sermorelin · 10 mg declared · Nantong Guangyuan Chemical Co., Ltd. · manufactured 11 Sep 2024

CHARACTERISED
Lot code
GGPE-2409-C8719
Supplier
GGPeps — Nantong Guangyuan Chemical Co., Ltd.
Compound
Sermorelin
Compound class
Growth-hormone axis peptides
Declared label claim
10mg
Manufacture date
11 Sep 2024
Index quarter
2024-Q4
Independent assays
11
Laboratories involved
Janoshik, Kestrel, Nordanalyt, Medutest, PeptideMeter
Provenance mix
Supplier-supplied ×11
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 98.43% n=11
Spread (max − min) 1.21pp n=11
Standard deviation 0.462pp n=11
97.497.898.398.799.199.6100.0This lot (GGPE-2409-C8719)This lot (GGPE-2409-C8719): Q1 98.13, median 98.43, Q3 98.96, n=11n=11All 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 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-2024-004961GGPE-2409-C8719Janoshik2024-Q498.056.16Supplier-supplied0PASS
AX-2024-004962GGPE-2409-C8719Kestrel2024-Q499.226.49Supplier-supplied1MARGINAL
AX-2024-004963GGPE-2409-C8719Nordanalyt2024-Q498.066.36101.4Supplier-supplied0PASS
AX-2024-004964GGPE-2409-C8719Medutest2024-Q498.206.12106.2Supplier-supplied1FAIL
AX-2024-004965GGPE-2409-C8719Medutest2024-Q498.836.75104.5Supplier-supplied0PASS
AX-2024-004966GGPE-2409-C8719Nordanalyt2024-Q498.436.53Supplier-supplied0PASS
AX-2024-004967GGPE-2409-C8719Medutest2024-Q498.276.5292.7Supplier-supplied0PASS
AX-2024-004968GGPE-2409-C8719PeptideMeter2024-Q498.016.35Supplier-supplied0PASS
AX-2024-004969GGPE-2409-C8719Medutest2024-Q499.096.1089.0Supplier-supplied1MARGINAL
AX-2024-004970GGPE-2409-C8719Medutest2024-Q499.125.91106.3Supplier-supplied0PASS
AX-2024-004971GGPE-2409-C8719Medutest2024-Q498.515.50102.5Supplier-supplied1FAIL
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
Janoshik198.0598.0530min+0.0098.05
Kestrel199.2299.2215min+0.2498.98
Nordanalyt298.06, 98.4398.2535min+0.0298.23
Medutest698.20, 98.83, 98.27, 99.09, 99.12, 98.5198.6725min+0.0898.59
PeptideMeter198.0198.0128min-0.0598.06

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)98.2698.05divergence -0.17 pp vs batch median
Total impurities (% area)1.741.95
Largest single impurity (% area)1.151.19
Water (%)5.96.16
Counter-ion (%)3.34.69
Peptide content (%w/w)90.2not determined
Endotoxin (EU/mg)not stated0.85
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
deamidated Asn8 (+1 Da)11 / 110.560.08–1.19
aspartimide (−18 Da)11 / 110.360.19–0.61
des-Tyr1 (−163 Da)11 / 110.140.06–0.19
truncated (1-25)11 / 110.170.07–1.01
Section 7

What this rollup does not establish