AssayIndex

KP-2406-K5337

IGF-1 LR3 · 0.1 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · manufactured 20 Jun 2024

CHARACTERISED
Lot code
KP-2406-K5337
Supplier
KP — Zhuhai Kerui Biotechnology Co., Ltd.
Compound
IGF-1 LR3
Compound class
Growth-hormone axis peptides
Declared label claim
0.10mg
Manufacture date
20 Jun 2024
Index quarter
2024-Q3
Independent assays
9
Laboratories involved
Janoshik, VendorInvestigate
Provenance mix
Buyer-sourced ×9
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 9
Median purity 97.93% n=9
Spread (max − min) 0.97pp n=9
Standard deviation 0.273pp n=9
96.396.997.698.298.999.5100.2This lot (KP-2406-K5337)This lot (KP-2406-K5337): Q1 97.91, median 97.93, Q3 98.17, n=9outlier 97.45n=9All IGF-1 LR3All IGF-1 LR3: Q1 97.75, median 98.06, Q3 98.48, n=118outlier 96.55outlier 99.59outlier 99.74outlier 99.84outlier 99.93n=118 Purity (% area)
Figure 1. This lot's independent purity results against the whole IGF-1 LR3 record set in the index. The vertical line is the index acceptance specification for the growth-hormone axis peptides class, 95.0 % 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 9

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-2024-005164KP-2406-K5337Janoshik2024-Q397.916.07103.0Buyer-sourced0PASS
AX-2024-005165KP-2406-K5337Janoshik2024-Q398.055.4787.0Buyer-sourced1MARGINAL
AX-2024-005166KP-2406-K5337Janoshik2024-Q398.176.0395.0Buyer-sourced1MARGINAL
AX-2024-005167KP-2406-K5337Janoshik2024-Q398.216.3395.0Buyer-sourced0PASS
AX-2024-005168KP-2406-K5337VendorInvestigate2024-Q398.426.73102.0Buyer-sourced0PASS
AX-2024-005169KP-2406-K5337Janoshik2024-Q397.855.66105.0Buyer-sourced0PASS
AX-2024-005170KP-2406-K5337Janoshik2024-Q397.936.2696.0Buyer-sourced0PASS
AX-2024-005171KP-2406-K5337Janoshik2024-Q397.936.31Buyer-sourced0PASS
AX-2024-005172KP-2406-K5337Janoshik2024-Q397.456.51Buyer-sourced0PASS
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
Janoshik897.91, 98.05, 98.17, 98.21, 97.85, 97.93, 97.93, 97.4597.9330min+0.0097.93
VendorInvestigate198.4298.4232min-0.1198.53

This lot contributes 1 paired comparison 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)98.5397.91divergence +0.60 pp vs batch median
Total impurities (% area)not stated2.09
Largest single impurity (% area)not stated1.18
Water (%)not stated6.07
Counter-ion (%)not stated5.21
Peptide content (%w/w)91.787.92
Endotoxin (EU/mg)0.25not 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
oxidised Met59 (+16 Da)9 / 90.900.30–1.44
disulfide-scrambled isomer9 / 90.730.45–1.47
des-13-residue N-extension (native IGF-1)9 / 90.160.08–0.26
truncated (1-70)9 / 90.060.05–0.08
aggregated dimer9 / 90.040.02–0.16
Section 7

What this rollup does not establish