AssayIndex

QSC-2511-T6680

Pramlintide · 2 mg declared · Qingdao Sigma Chemical Co., Ltd. · manufactured 19 Nov 2025

CHARACTERISED
Lot code
QSC-2511-T6680
Supplier
QSC — Qingdao Sigma Chemical Co., Ltd.
Compound
Pramlintide
Compound class
Incretin analogues and co-agonists
Declared label claim
2mg
Manufacture date
19 Nov 2025
Index quarter
2026-Q1
Independent assays
10
Laboratories involved
PeptideMeter, Janoshik, VendorInvestigate
Provenance mix
Buyer-sourced ×2 · Supplier-supplied ×7 · 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 10
Median purity 99.13% n=10
Spread (max − min) 1.70pp n=10
Standard deviation 0.466pp n=10
97.798.198.598.999.399.7100.1This lot (QSC-2511-T6680)This lot (QSC-2511-T6680): Q1 98.82, median 99.13, Q3 99.32, n=10n=10All PramlintideAll Pramlintide: Q1 98.52, median 98.84, Q3 99.16, n=33n=33 Purity (% area)
Figure 1. This lot's independent purity results against the whole Pramlintide record set in the index. The vertical line is the index acceptance specification for the incretin analogues and co-agonists 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 10

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-2026-041563QSC-2511-T6680PeptideMeter2026-Q199.106.1094.2Supplier-supplied0PASS
AX-2026-041564QSC-2511-T6680Janoshik2026-Q198.925.77103.2Laboratory-retained0PASS
AX-2026-041565QSC-2511-T6680PeptideMeter2026-Q199.155.74Supplier-supplied0PASS
AX-2026-041566QSC-2511-T6680PeptideMeter2026-Q199.935.27106.7Supplier-supplied1MARGINAL
AX-2026-041567QSC-2511-T6680Janoshik2026-Q198.735.07Supplier-supplied1MARGINAL
AX-2026-041568QSC-2511-T6680Janoshik2026-Q199.165.45Supplier-supplied0PASS
AX-2026-041569QSC-2511-T6680VendorInvestigate2026-Q198.795.6394.4Buyer-sourced2MARGINAL
AX-2026-041570QSC-2511-T6680VendorInvestigate2026-Q198.235.45Buyer-sourced1MARGINAL
AX-2026-041571QSC-2511-T6680PeptideMeter2026-Q199.515.2596.7Supplier-supplied0PASS
AX-2026-041572QSC-2511-T6680Janoshik2026-Q199.375.63Supplier-supplied0PASS
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
PeptideMeter499.10, 99.15, 99.93, 99.5199.3328min-0.0599.38
Janoshik498.92, 98.73, 99.16, 99.3799.0430min+0.0099.04
VendorInvestigate298.79, 98.2398.5132min-0.1198.62

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)99.8299.10divergence +0.69 pp vs batch median
Total impurities (% area)0.180.90
Largest single impurity (% area)0.120.41
Water (%)3.86.10
Counter-ion (%)not stated3.76
Peptide content (%w/w)not stated89.27
Endotoxin (EU/mg)not stated0.87
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
C-terminal free acid (+1 Da)10 / 100.290.03–0.58
open-chain (reduced disulfide, +2 Da)10 / 100.210.04–1.09
pramlintide dimer9 / 100.160.06–0.29
des-Lys1 (−128 Da)9 / 100.120.05–0.18
Section 7

What this rollup does not establish