AssayIndex

TFS-{CAT}-1220

CJC-1295 with DAC · 10 mg declared · Thermo Fisher Scientific (China) Co., Ltd. · manufactured 02 Apr 2025

CHARACTERISEDSHARED BULK
Lot code
TFS-{CAT}-1220
Supplier
TFS — Thermo Fisher Scientific (China) Co., Ltd.
Compound
CJC-1295 with DAC
Compound class
Growth-hormone axis peptides
Declared label claim
10mg
Manufacture date
02 Apr 2025
Index quarter
2025-Q2
Independent assays
14
Laboratories involved
Janoshik, PeptideMeter, Medutest, Nordanalyt
Provenance mix
Buyer-sourced ×13 · 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 14
Median purity 98.64% n=14
Spread (max − min) 1.17pp n=14
Standard deviation 0.328pp n=14
96.697.297.898.499.099.6100.2This lot (TFS-{CAT}-1220)This lot (TFS-{CAT}-1220): Q1 98.49, median 98.64, Q3 98.74, n=14outlier 99.27outlier 99.41n=14All CJC-1295 with DACAll CJC-1295 with DAC: Q1 98.44, median 98.95, Q3 99.25, n=121outlier 96.83outlier 96.99outlier 97.16outlier 97.20outlier 97.21n=121 Purity (% area)
Figure 1. This lot's independent purity results against the whole CJC-1295 with DAC record set in the index. The vertical line is the index acceptance specification for the growth-hormone axis peptides class, 97.5 % 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-2025-018903TFS-{CAT}-1220Janoshik2025-Q298.653.98Buyer-sourced1MARGINAL
AX-2025-018904TFS-{CAT}-1220Janoshik2025-Q299.414.43Buyer-sourced1MARGINAL
AX-2025-018905TFS-{CAT}-1220Janoshik2025-Q298.724.16105.3Buyer-sourced1MARGINAL
AX-2025-018906TFS-{CAT}-1220PeptideMeter2025-Q298.494.63105.9Buyer-sourced1MARGINAL
AX-2025-018907TFS-{CAT}-1220Janoshik2025-Q299.274.97103.6Buyer-sourced1MARGINAL
AX-2025-018908TFS-{CAT}-1220PeptideMeter2025-Q298.684.38Buyer-sourced1MARGINAL
AX-2025-018909TFS-{CAT}-1220Medutest2025-Q298.363.93Buyer-sourced1MARGINAL
AX-2025-018910TFS-{CAT}-1220Janoshik2025-Q298.604.2696.7Buyer-sourced1MARGINAL
AX-2025-018911TFS-{CAT}-1220Janoshik2025-Q298.624.30Buyer-sourced1MARGINAL
AX-2025-018912TFS-{CAT}-1220Janoshik2025-Q298.754.74Buyer-sourced1MARGINAL
AX-2025-018913TFS-{CAT}-1220Janoshik2025-Q298.244.0799.7Laboratory-retained1MARGINAL
AX-2025-018914TFS-{CAT}-1220Janoshik2025-Q298.874.81103.0Buyer-sourced1MARGINAL
AX-2025-018915TFS-{CAT}-1220Nordanalyt2025-Q298.504.5196.2Buyer-sourced1MARGINAL
AX-2025-018916TFS-{CAT}-1220PeptideMeter2025-Q298.363.9699.0Buyer-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
Janoshik998.65, 99.41, 98.72, 99.27, 98.60, 98.62, 98.75, 98.24, 98.8798.7230min+0.0098.72
PeptideMeter398.49, 98.68, 98.3698.4928min-0.0598.54
Medutest198.3698.3625min+0.0898.28
Nordanalyt198.5098.5035min+0.0298.48

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)98.6898.65divergence +0.04 pp vs batch median
Total impurities (% area)1.321.35
Largest single impurity (% area)not stated0.58
Water (%)2.13.98
Counter-ion (%)5.84.98
Peptide content (%w/w)91.5not determined
Endotoxin (EU/mg)0.110.21
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
mod-GRF (1-29) (−279 Da)14 / 140.240.06–0.75
deamidated (+1 Da)14 / 140.200.04–0.66
hydrolysed maleimide (+18 Da)14 / 140.170.07–0.23
maleimide dimer14 / 140.270.05–1.17
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-2605-P3253TFCparent bulk199.27
TFS-{CAT}-1220TFSthis lot1498.64
Section 7

What this rollup does not establish