AssayIndex

GLBI-2407-U8370

CJC-1295 (no DAC) · 2 mg declared · GL Biochem (Shanghai) Ltd. · manufactured 21 Jul 2024

CHARACTERISEDSHARED BULK
Lot code
GLBI-2407-U8370
Supplier
GL Biochem — GL Biochem (Shanghai) Ltd.
Compound
CJC-1295 (no DAC)
Compound class
Growth-hormone axis peptides
Declared label claim
2mg
Manufacture date
21 Jul 2024
Index quarter
2024-Q3
Independent assays
4
Laboratories involved
Janoshik, VendorInvestigate, Nordanalyt
Provenance mix
Buyer-sourced ×1 · Supplier-supplied ×3
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 4
Median purity 97.92% n=4
Spread (max − min) 0.39pp n=4
Standard deviation 0.168pp n=4
96.597.197.798.398.999.6100.2This lot (GLBI-2407-U8370)This lot (GLBI-2407-U8370): Q1 97.81, median 97.91, Q3 97.99, n=4n=4All CJC-1295 (no DAC)All CJC-1295 (no DAC): Q1 98.02, median 98.61, Q3 99.18, n=137n=137 Purity (% area)
Figure 1. This lot's independent purity results against the whole CJC-1295 (no DAC) record set in the index. The vertical line is the index acceptance specification for the growth-hormone axis peptides class, 98.0 % 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 4

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-2024-005278GLBI-2407-U8370Janoshik2024-Q397.974.6198.7Supplier-supplied2FAIL
AX-2024-005279GLBI-2407-U8370VendorInvestigate2024-Q397.675.54100.9Buyer-sourced3FAIL
AX-2024-005280GLBI-2407-U8370Nordanalyt2024-Q397.865.75105.0Supplier-supplied3FAIL
AX-2024-005281GLBI-2407-U8370Janoshik2024-Q398.065.40Supplier-supplied3MARGINAL
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
Janoshik297.97, 98.0698.0230min+0.0098.02
VendorInvestigate197.6797.6732min-0.1197.78
Nordanalyt197.8697.8635min+0.0297.84

This lot contributes 3 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)98.597.97divergence +0.58 pp vs batch median
Total impurities (% area)1.502.03
Largest single impurity (% area)1.000.75
Water (%)3.04.61
Counter-ion (%)not stated4.59
Peptide content (%w/w)not stated90.32
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
des-Tyr1 (−163 Da)4 / 40.540.26–0.79
native GRF (1-29) (−59 Da)4 / 40.990.60–1.59
truncated (1-24)4 / 40.290.12–0.44
acetyl adduct (+42 Da)4 / 40.120.09–0.14
deamidated (+1 Da)4 / 40.140.12–0.17
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
QSC-2410-L8549QSClinked child298.43
MKM-2512-Y3111MKMlinked child297.67
GLBI-2407-U8370GL Biochemthis lot497.92
Section 7

What this rollup does not establish