AssayIndex

FGP-2409-T2292

Ipamorelin · 2 mg declared · Flourishglobal Peptide Biotech (Chengdu) Co., Ltd. · manufactured 06 Sep 2024

CHARACTERISED
Lot code
FGP-2409-T2292
Supplier
FGP — Flourishglobal Peptide Biotech (Chengdu) Co., Ltd.
Compound
Ipamorelin
Compound class
Growth-hormone axis peptides
Declared label claim
2mg
Manufacture date
06 Sep 2024
Index quarter
2024-Q4
Independent assays
11
Laboratories involved
Janoshik, PeptideMeter, Kestrel, Nordanalyt
Provenance mix
Supplier-supplied ×9 · Laboratory-retained ×2
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 99.55% n=11
Spread (max − min) 0.96pp n=11
Standard deviation 0.346pp n=11
97.197.698.198.699.199.6100.1This lot (FGP-2409-T2292)This lot (FGP-2409-T2292): Q1 99.31, median 99.55, Q3 99.92, n=11n=11All IpamorelinAll Ipamorelin: Q1 98.97, median 99.48, Q3 99.93, n=223outlier 97.34outlier 97.51n=223 Purity (% area)
Figure 1. This lot's independent purity results against the whole Ipamorelin record set in the index. The vertical line is the index acceptance specification for the growth-hormone axis peptides class, 99.0 % 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-2024-004522FGP-2409-T2292Janoshik2024-Q499.295.05Supplier-supplied1MARGINAL
AX-2024-004523FGP-2409-T2292PeptideMeter2024-Q499.344.07Supplier-supplied1MARGINAL
AX-2024-004524FGP-2409-T2292Janoshik2024-Q499.914.41Supplier-supplied0PASS
AX-2024-004525FGP-2409-T2292Kestrel2024-Q499.934.5694.4Supplier-supplied0PASS
AX-2024-004526FGP-2409-T2292Janoshik2024-Q499.554.73103.4Laboratory-retained0PASS
AX-2024-004527FGP-2409-T2292Nordanalyt2024-Q499.344.82102.7Supplier-supplied1MARGINAL
AX-2024-004528FGP-2409-T2292Janoshik2024-Q499.684.32Supplier-supplied0PASS
AX-2024-004529FGP-2409-T2292Janoshik2024-Q498.974.53Supplier-supplied1FAIL
AX-2024-004530FGP-2409-T2292Janoshik2024-Q499.934.6797.4Supplier-supplied0PASS
AX-2024-004531FGP-2409-T2292Kestrel2024-Q499.935.08106.5Supplier-supplied1FAIL
AX-2024-004532FGP-2409-T2292Kestrel2024-Q499.204.8092.9Laboratory-retained1MARGINAL
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
Janoshik699.29, 99.91, 99.55, 99.68, 98.97, 99.9399.6230min+0.0099.62
PeptideMeter199.3499.3428min-0.0599.39
Kestrel399.93, 99.93, 99.2099.9315min+0.2499.69
Nordanalyt199.3499.3435min+0.0299.32

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)99.8999.29divergence +0.34 pp vs batch median
Total impurities (% area)0.110.71
Largest single impurity (% area)not stated0.39
Water (%)3.25.05
Counter-ion (%)not stated6.14
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)0.23not 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-Lys (−128 Da)11 / 110.110.04–0.44
Aib-deletion sequence (−85 Da)10 / 110.080.01–0.69
oxidised Trp (+16 Da)9 / 110.040.02–0.17
C-terminal free acid (+1 Da)7 / 110.030.02–0.05
[D-Trp]-epimer5 / 110.060.03–0.09
Section 7

What this rollup does not establish