AssayIndex

SGN-2408-K1629

CJC-1295 with DAC · 5 mg declared · Sangon Biotech (Shanghai) Co., Ltd. · manufactured 08 Aug 2024

CHARACTERISED
Lot code
SGN-2408-K1629
Supplier
SGN — Sangon Biotech (Shanghai) Co., Ltd.
Compound
CJC-1295 with DAC
Compound class
Growth-hormone axis peptides
Declared label claim
5mg
Manufacture date
08 Aug 2024
Index quarter
2025-Q1
Independent assays
8
Laboratories involved
PeptideMeter, Janoshik, Nordanalyt, Kestrel
Provenance mix
Buyer-sourced ×1 · Supplier-supplied ×7
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 8
Median purity 98.43% n=8
Spread (max − min) 0.73pp n=8
Standard deviation 0.275pp n=8
96.497.097.798.398.999.6100.2This lot (SGN-2408-K1629)This lot (SGN-2408-K1629): Q1 98.33, median 98.42, Q3 98.77, n=8n=8All CJC-1295 with DACAll CJC-1295 with DAC: Q1 98.26, median 98.79, Q3 99.30, n=136outlier 96.67n=136 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 8

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-2025-020838SGN-2408-K1629PeptideMeter2025-Q198.774.2294.6Supplier-supplied2MARGINAL
AX-2025-020839SGN-2408-K1629Janoshik2025-Q198.903.86Supplier-supplied2MARGINAL
AX-2025-020840SGN-2408-K1629Nordanalyt2025-Q198.414.65105.8Supplier-supplied2MARGINAL
AX-2025-020841SGN-2408-K1629Janoshik2025-Q198.223.93105.8Supplier-supplied2MARGINAL
AX-2025-020842SGN-2408-K1629Janoshik2025-Q198.783.6196.6Supplier-supplied2MARGINAL
AX-2025-020843SGN-2408-K1629Kestrel2025-Q198.443.89Buyer-sourced2MARGINAL
AX-2025-020844SGN-2408-K1629PeptideMeter2025-Q198.364.6092.5Supplier-supplied2MARGINAL
AX-2025-020845SGN-2408-K1629Janoshik2025-Q198.173.98Supplier-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
PeptideMeter298.77, 98.3698.5628min-0.0598.61
Janoshik498.90, 98.22, 98.78, 98.1798.5030min+0.0098.50
Nordanalyt198.4198.4135min+0.0298.39
Kestrel198.4498.4415min+0.2498.20

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)98.9998.77divergence +0.56 pp vs batch median
Total impurities (% area)not stated1.23
Largest single impurity (% area)not stated0.58
Water (%)not stated4.22
Counter-ion (%)not stated4.49
Peptide content (%w/w)not stated90.84
Endotoxin (EU/mg)0.46not 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
hydrolysed maleimide (+18 Da)8 / 80.390.12–0.76
maleimide dimer8 / 80.230.11–0.37
deamidated (+1 Da)8 / 80.270.20–0.38
mod-GRF (1-29) (−279 Da)8 / 80.440.18–1.06
Section 7

What this rollup does not establish