AssayIndex

BCH-2405-U6438

Semaglutide · 15 mg declared · Bachem Holding (Suzhou) Co., Ltd. · manufactured 02 May 2024

CHARACTERISED
Lot code
BCH-2405-U6438
Supplier
BCH — Bachem Holding (Suzhou) Co., Ltd.
Compound
Semaglutide
Compound class
Incretin analogues and co-agonists
Declared label claim
15mg
Manufacture date
02 May 2024
Index quarter
2024-Q2
Independent assays
14
Laboratories involved
Janoshik, Kestrel, VendorInvestigate, PeptideMeter, Nordanalyt, Medutest
Provenance mix
Buyer-sourced ×6 · Supplier-supplied ×8
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 14
Median purity 97.74% n=14
Spread (max − min) 1.40pp n=14
Standard deviation 0.347pp n=14
96.196.897.598.298.899.5100.2This lot (BCH-2405-U6438)This lot (BCH-2405-U6438): Q1 97.54, median 97.73, Q3 97.92, n=14outlier 98.58n=14All SemaglutideAll Semaglutide: Q1 98.24, median 98.87, Q3 99.33, n=926outlier 96.37n=926 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 14

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-2024-005460BCH-2405-U6438Janoshik2024-Q297.543.83Buyer-sourced3FAIL
AX-2024-005461BCH-2405-U6438Kestrel2024-Q297.773.98Supplier-supplied2MARGINAL
AX-2024-005462BCH-2405-U6438VendorInvestigate2024-Q297.183.63Buyer-sourced2MARGINAL
AX-2024-005463BCH-2405-U6438PeptideMeter2024-Q297.664.04Buyer-sourced2MARGINAL
AX-2024-005464BCH-2405-U6438Janoshik2024-Q297.814.50Supplier-supplied2MARGINAL
AX-2024-005465BCH-2405-U6438Nordanalyt2024-Q297.704.25102.6Supplier-supplied2MARGINAL
AX-2024-005466BCH-2405-U6438VendorInvestigate2024-Q297.793.81Buyer-sourced2MARGINAL
AX-2024-005467BCH-2405-U6438Janoshik2024-Q297.964.6099.7Supplier-supplied2MARGINAL
AX-2024-005468BCH-2405-U6438Medutest2024-Q297.414.45Supplier-supplied2MARGINAL
AX-2024-005469BCH-2405-U6438VendorInvestigate2024-Q297.374.05106.7Buyer-sourced2MARGINAL
AX-2024-005470BCH-2405-U6438VendorInvestigate2024-Q297.554.01Buyer-sourced2MARGINAL
AX-2024-005471BCH-2405-U6438PeptideMeter2024-Q298.084.45Supplier-supplied2MARGINAL
AX-2024-005472BCH-2405-U6438Janoshik2024-Q297.964.3190.5Supplier-supplied2MARGINAL
AX-2024-005473BCH-2405-U6438Medutest2024-Q298.584.0994.5Supplier-supplied2MARGINAL
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
Janoshik497.54, 97.81, 97.96, 97.9697.8830min+0.0097.88
Kestrel197.7797.7715min+0.2497.53
VendorInvestigate497.18, 97.79, 97.37, 97.5597.4632min-0.1197.57
PeptideMeter297.66, 98.0897.8728min-0.0597.92
Nordanalyt197.7097.7035min+0.0297.68
Medutest297.41, 98.5898.0025min+0.0897.92

This lot contributes 15 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)98.097.54divergence +0.26 pp vs batch median
Total impurities (% area)2.002.46
Largest single impurity (% area)1.191.73
Water (%)3.03.83
Counter-ion (%)not stated7.01
Peptide content (%w/w)92.2not determined
Endotoxin (EU/mg)not statednot determined
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
[D-Aib8]-diastereomer14 / 141.560.97–1.98
des-AEEA semaglutide (−145 Da)14 / 140.290.15–0.40
des-His1 truncate (−137 Da)14 / 140.040.01–0.07
deamidated (Asn→Asp, +1 Da)14 / 140.030.02–0.04
Met(O) sulfoxide (+16 Da)14 / 140.040.02–0.08
tBu-protected residual (+56 Da)7 / 140.270.22–0.31
C18 diacid mono-ester7 / 140.340.22–0.40
Section 7

What this rollup does not establish