AssayIndex

CPC-2403-R3097

Pinealon · 20 mg declared · Chinese Peptide Company Co., Ltd. · manufactured 02 Mar 2024

CHARACTERISED
Lot code
CPC-2403-R3097
Supplier
CPC — Chinese Peptide Company Co., Ltd.
Compound
Pinealon
Compound class
Short bioregulator peptides
Declared label claim
20mg
Manufacture date
02 Mar 2024
Index quarter
2024-Q2
Independent assays
14
Laboratories involved
Janoshik, Nordanalyt, Medutest, PeptideMeter, VendorInvestigate
Provenance mix
Buyer-sourced ×4 · Supplier-supplied ×10
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 99.16% n=14
Spread (max − min) 1.24pp n=14
Standard deviation 0.339pp n=14
98.498.799.099.299.599.8100.0This lot (CPC-2403-R3097)This lot (CPC-2403-R3097): Q1 99.06, median 99.16, Q3 99.31, n=14outlier 98.53outlier 99.77n=14All PinealonAll Pinealon: Q1 99.07, median 99.24, Q3 99.80, n=19n=19 Purity (% area)
Figure 1. This lot's independent purity results against the whole Pinealon record set in the index. The vertical line is the index acceptance specification for the short bioregulator peptides class, 99.0 % 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-2024-005377CPC-2403-R3097Janoshik2024-Q299.347.93Supplier-supplied1FAIL
AX-2024-005378CPC-2403-R3097Janoshik2024-Q299.078.4797.1Supplier-supplied1MARGINAL
AX-2024-005379CPC-2403-R3097Janoshik2024-Q299.698.68Supplier-supplied1FAIL
AX-2024-005380CPC-2403-R3097Janoshik2024-Q299.248.6690.1Supplier-supplied1MARGINAL
AX-2024-005381CPC-2403-R3097Janoshik2024-Q299.068.5291.9Supplier-supplied1MARGINAL
AX-2024-005382CPC-2403-R3097Nordanalyt2024-Q299.128.36Supplier-supplied1MARGINAL
AX-2024-005383CPC-2403-R3097Nordanalyt2024-Q299.237.78Supplier-supplied1MARGINAL
AX-2024-005384CPC-2403-R3097Medutest2024-Q299.198.12Buyer-sourced1FAIL
AX-2024-005385CPC-2403-R3097PeptideMeter2024-Q298.868.4389.0Buyer-sourced2FAIL
AX-2024-005386CPC-2403-R3097Medutest2024-Q299.668.36106.9Supplier-supplied2FAIL
AX-2024-005387CPC-2403-R3097Medutest2024-Q298.938.28100.8Buyer-sourced1FAIL
AX-2024-005388CPC-2403-R3097PeptideMeter2024-Q299.778.00Supplier-supplied1FAIL
AX-2024-005389CPC-2403-R3097VendorInvestigate2024-Q298.538.2495.9Buyer-sourced1FAIL
AX-2024-005390CPC-2403-R3097Medutest2024-Q299.087.89Supplier-supplied1FAIL
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
Janoshik599.34, 99.07, 99.69, 99.24, 99.0699.2430min+0.0099.24
Nordanalyt299.12, 99.2399.1835min+0.0299.16
Medutest499.19, 99.66, 98.93, 99.0899.1325min+0.0899.05
PeptideMeter298.86, 99.7799.3128min-0.0599.36
VendorInvestigate198.5398.5332min-0.1198.64

This lot contributes 10 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)99.599.34divergence +0.34 pp vs batch median
Total impurities (% area)0.500.66
Largest single impurity (% area)0.370.37
Water (%)not stated7.93
Counter-ion (%)not stated14.13
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)not statednot determined
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
Glu-Asp dipeptide (−156 Da)14 / 140.150.04–0.82
pyroglutamate (−18 Da)14 / 140.210.06–0.30
aspartimide (−18 Da)14 / 140.180.05–0.49
Asp-Arg dipeptide (−129 Da)13 / 140.060.02–0.12
Section 7

What this rollup does not establish