AssayIndex

BCH-2502-H6657

PT-141 (Bremelanotide) · 10 mg declared · Bachem Holding (Suzhou) Co., Ltd. · manufactured 01 Feb 2025

CHARACTERISED
Lot code
BCH-2502-H6657
Supplier
BCH — Bachem Holding (Suzhou) Co., Ltd.
Compound
PT-141 (Bremelanotide)
Compound class
Melanocortin-receptor peptides
Declared label claim
10mg
Manufacture date
01 Feb 2025
Index quarter
2025-Q2
Independent assays
11
Laboratories involved
Medutest, Janoshik, PeptideMeter, Nordanalyt, Kestrel
Provenance mix
Buyer-sourced ×1 · Supplier-supplied ×9 · 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 11
Median purity 99.31% n=11
Spread (max − min) 1.37pp n=11
Standard deviation 0.388pp n=11
97.497.898.398.899.299.7100.1This lot (BCH-2502-H6657)This lot (BCH-2502-H6657): Q1 99.05, median 99.31, Q3 99.43, n=11n=11All PT-141 (Bremelanotide)All PT-141 (Bremelanotide): Q1 98.69, median 99.31, Q3 99.84, n=200n=200 Purity (% area)
Figure 1. This lot's independent purity results against the whole PT-141 (Bremelanotide) record set in the index. The vertical line is the index acceptance specification for the melanocortin-receptor peptides 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 11

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-2025-021185BCH-2502-H6657Medutest2025-Q299.365.60Supplier-supplied0PASS
AX-2025-021186BCH-2502-H6657Janoshik2025-Q299.055.86Supplier-supplied0PASS
AX-2025-021187BCH-2502-H6657Janoshik2025-Q298.566.4796.1Buyer-sourced0PASS
AX-2025-021188BCH-2502-H6657Medutest2025-Q299.316.0090.4Supplier-supplied0PASS
AX-2025-021189BCH-2502-H6657Janoshik2025-Q299.426.36Supplier-supplied0PASS
AX-2025-021190BCH-2502-H6657PeptideMeter2025-Q299.205.74Supplier-supplied0PASS
AX-2025-021191BCH-2502-H6657Nordanalyt2025-Q299.055.28104.7Supplier-supplied0PASS
AX-2025-021192BCH-2502-H6657PeptideMeter2025-Q299.615.4692.1Supplier-supplied0PASS
AX-2025-021193BCH-2502-H6657Janoshik2025-Q299.436.24Supplier-supplied0PASS
AX-2025-021194BCH-2502-H6657Kestrel2025-Q299.935.4692.7Supplier-supplied0PASS
AX-2025-021195BCH-2502-H6657Janoshik2025-Q298.725.9492.6Laboratory-retained0PASS
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
Medutest299.36, 99.3199.3425min+0.0899.26
Janoshik599.05, 98.56, 99.42, 99.43, 98.7299.0530min+0.0099.05
PeptideMeter299.20, 99.6199.4128min-0.0599.45
Nordanalyt199.0599.0535min+0.0299.03
Kestrel199.9399.9315min+0.2499.69

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)99.2599.36divergence -0.06 pp vs batch median
Total impurities (% area)0.750.64
Largest single impurity (% area)0.360.45
Water (%)not stated5.60
Counter-ion (%)8.33.47
Peptide content (%w/w)87.6not determined
Endotoxin (EU/mg)not stated0.50
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
linear precursor (+18 Da)11 / 110.220.05–0.66
melanotan II (C-terminal amide, −1 Da)11 / 110.070.02–0.19
des-acetyl (−42 Da)10 / 110.410.02–1.01
oxidised Trp (+16 Da)10 / 110.040.02–0.10
Section 7

What this rollup does not establish