AssayIndex

HOMO-2405-U3389

Oxytocin · 2 mg declared · Hunan Aslsen Technology Co., Ltd. · manufactured 28 May 2024

CHARACTERISED
Lot code
HOMO-2405-U3389
Supplier
Homopeptide — Hunan Aslsen Technology Co., Ltd.
Compound
Oxytocin
Compound class
Hypothalamic and posterior-pituitary hormones
Declared label claim
2mg
Manufacture date
28 May 2024
Index quarter
2024-Q3
Independent assays
14
Laboratories involved
Janoshik, Nordanalyt, VendorInvestigate, Medutest
Provenance mix
Buyer-sourced ×12 · Supplier-supplied ×1 · 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 99.93% n=14
Spread (max − min) 0.30pp n=14
Standard deviation 0.101pp n=14
98.999.199.399.599.699.8100.0This lot (HOMO-2405-U3389)This lot (HOMO-2405-U3389): Q1 99.88, median 99.93, Q3 99.93, n=14outlier 99.63outlier 99.73outlier 99.73n=14All OxytocinAll Oxytocin: Q1 99.62, median 99.81, Q3 99.93, n=48outlier 98.98outlier 99.02outlier 99.09outlier 99.10outlier 99.11outlier 99.11n=48 Purity (% area)
Figure 1. This lot's independent purity results against the whole Oxytocin record set in the index. The vertical line is the index acceptance specification for the hypothalamic and posterior-pituitary hormones class, 98.5 % 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-2024-004706HOMO-2405-U3389Janoshik2024-Q399.935.57104.1Buyer-sourced0PASS
AX-2024-004707HOMO-2405-U3389Janoshik2024-Q399.936.2894.4Buyer-sourced0PASS
AX-2024-004708HOMO-2405-U3389Janoshik2024-Q399.935.7490.4Buyer-sourced1FAIL
AX-2024-004709HOMO-2405-U3389Janoshik2024-Q399.935.12Buyer-sourced0PASS
AX-2024-004710HOMO-2405-U3389Janoshik2024-Q399.936.56101.4Buyer-sourced0PASS
AX-2024-004711HOMO-2405-U3389Nordanalyt2024-Q399.925.88104.0Buyer-sourced0PASS
AX-2024-004712HOMO-2405-U3389VendorInvestigate2024-Q399.736.2492.2Buyer-sourced0PASS
AX-2024-004713HOMO-2405-U3389VendorInvestigate2024-Q399.635.73102.3Laboratory-retained0PASS
AX-2024-004714HOMO-2405-U3389Nordanalyt2024-Q399.936.78105.5Supplier-supplied0PASS
AX-2024-004715HOMO-2405-U3389Janoshik2024-Q399.936.44Buyer-sourced0PASS
AX-2024-004716HOMO-2405-U3389Janoshik2024-Q399.935.57Buyer-sourced0FAIL
AX-2024-004717HOMO-2405-U3389Medutest2024-Q399.866.13Buyer-sourced0PASS
AX-2024-004718HOMO-2405-U3389Janoshik2024-Q399.936.05Buyer-sourced0PASS
AX-2024-004719HOMO-2405-U3389Medutest2024-Q399.735.50Buyer-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
Janoshik899.93, 99.93, 99.93, 99.93, 99.93, 99.93, 99.93, 99.9399.9330min+0.0099.93
Nordanalyt299.92, 99.9399.9335min+0.0299.91
VendorInvestigate299.73, 99.6399.6832min-0.1199.79
Medutest299.86, 99.7399.8025min+0.0899.72

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)99.7399.93divergence -0.20 pp vs batch median
Total impurities (% area)0.270.07
Largest single impurity (% area)not stated0.04
Water (%)5.55.57
Counter-ion (%)not stated6.07
Peptide content (%w/w)not stated87.52
Endotoxin (EU/mg)4.09not 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
deamidated Gln4 (+1 Da)9 / 140.040.04–0.10
open-chain (reduced disulfide, +2 Da)8 / 140.050.02–0.14
oxytocin dimer (intermolecular disulfide)8 / 140.030.02–0.12
des-Gly9 (−57 Da)7 / 140.030.03–0.11
Tyr sulfoxide artefact (+16 Da)4 / 140.040.03–0.05
Section 7

What this rollup does not establish