AssayIndex

GGPE-2408-Y1566

Semaglutide · 10 mg declared · Nantong Guangyuan Chemical Co., Ltd. · manufactured 20 Aug 2024

CHARACTERISEDSHARED BULK
Lot code
GGPE-2408-Y1566
Supplier
GGPeps — Nantong Guangyuan Chemical Co., Ltd.
Compound
Semaglutide
Compound class
Incretin analogues and co-agonists
Declared label claim
10mg
Manufacture date
20 Aug 2024
Index quarter
2024-Q3
Independent assays
11
Laboratories involved
Janoshik, Nordanalyt, Kestrel, PeptideMeter, Medutest
Provenance mix
Buyer-sourced ×10 · 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 11
Median purity 98.43% n=11
Spread (max − min) 1.05pp n=11
Standard deviation 0.329pp n=11
96.597.197.798.398.999.6100.2This lot (GGPE-2408-Y1566)This lot (GGPE-2408-Y1566): Q1 98.23, median 98.43, Q3 98.65, n=11n=11All SemaglutideAll Semaglutide: Q1 98.38, median 98.86, Q3 99.30, n=844outlier 96.71outlier 96.74outlier 96.77outlier 96.93outlier 96.96outlier 96.98outlier 96.99outlier 96.99n=844 Purity (% area)
Figure 1. This lot's independent purity results against the whole Semaglutide record set in the index. The vertical line is the index acceptance specification for the incretin analogues and co-agonists class, 97.0 % 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-2024-005041GGPE-2408-Y1566Janoshik2024-Q397.926.09Buyer-sourced1MARGINAL
AX-2024-005042GGPE-2408-Y1566Janoshik2024-Q398.676.37Laboratory-retained1MARGINAL
AX-2024-005043GGPE-2408-Y1566Nordanalyt2024-Q398.436.8194.7Buyer-sourced1MARGINAL
AX-2024-005044GGPE-2408-Y1566Kestrel2024-Q398.886.50Buyer-sourced1MARGINAL
AX-2024-005045GGPE-2408-Y1566Janoshik2024-Q398.176.0393.5Buyer-sourced1MARGINAL
AX-2024-005046GGPE-2408-Y1566Nordanalyt2024-Q398.306.50Buyer-sourced1MARGINAL
AX-2024-005047GGPE-2408-Y1566PeptideMeter2024-Q397.835.8392.4Buyer-sourced1MARGINAL
AX-2024-005048GGPE-2408-Y1566Medutest2024-Q398.446.55Buyer-sourced2FAIL
AX-2024-005049GGPE-2408-Y1566Nordanalyt2024-Q398.625.9798.3Buyer-sourced1MARGINAL
AX-2024-005050GGPE-2408-Y1566Janoshik2024-Q398.735.8994.7Buyer-sourced1MARGINAL
AX-2024-005051GGPE-2408-Y1566Janoshik2024-Q398.395.6692.4Buyer-sourced1MARGINAL
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
Janoshik597.92, 98.67, 98.17, 98.73, 98.3998.3930min+0.0098.39
Nordanalyt398.43, 98.30, 98.6298.4335min+0.0298.41
Kestrel198.8898.8815min+0.2498.64
PeptideMeter197.8397.8328min-0.0597.88
Medutest198.4498.4425min+0.0898.36

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)98.3097.92divergence -0.13 pp vs batch median
Total impurities (% area)not stated2.08
Largest single impurity (% area)not stated0.86
Water (%)5.76.09
Counter-ion (%)not stated10.67
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)not stated0.40
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
C18 diacid mono-ester11 / 110.570.05–0.90
des-AEEA semaglutide (−145 Da)11 / 110.240.16–0.55
Met(O) sulfoxide (+16 Da)11 / 110.070.03–0.12
des-His1 truncate (−137 Da)11 / 110.070.05–0.23
semaglutide dimer10 / 110.040.03–0.06
[D-Aib8]-diastereomer6 / 110.610.49–0.77
deamidated (Asn→Asp, +1 Da)5 / 110.710.58–0.77
Section 6

Shared-bulk links

Rule AX-R09. Where impurity fingerprints and latent composition match across companies, the index treats the material as one bulk and counts it once in aggregates.

LotSold byRoleReportsMedian purity
TFC-2507-K8596TFCparent bulk1198.31
GGPE-2408-Y1566GGPepsthis lot1198.43
Section 7

What this rollup does not establish