KP-2312-R4578
Sermorelin · 15 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · manufactured 20 Dec 2023
- Lot code
- KP-2312-R4578
- Supplier
- KP — Zhuhai Kerui Biotechnology Co., Ltd.
- Compound
- Sermorelin
- Compound class
- Growth-hormone axis peptides
- Declared label claim
- 15mg
- Manufacture date
- 20 Dec 2023
- Index quarter
- 2024-Q2
- Independent assays
- 10
- Laboratories involved
- Janoshik, Medutest, Nordanalyt, VendorInvestigate
- Provenance mix
- Buyer-sourced ×1 · Supplier-supplied ×8 · Laboratory-retained ×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.
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.
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-005124 | KP-2312-R4578 | Janoshik | 2024-Q2 | 99.25 | 6.77 | 93.7 | Supplier-supplied | 0 | PASS |
| AX-2024-005125 | KP-2312-R4578 | Janoshik | 2024-Q2 | 99.50 | 7.05 | — | Supplier-supplied | 0 | PASS |
| AX-2024-005126 | KP-2312-R4578 | Janoshik | 2024-Q2 | 98.80 | 7.25 | 100.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005127 | KP-2312-R4578 | Medutest | 2024-Q2 | 99.36 | 7.55 | 102.2 | Supplier-supplied | 1 | FAIL |
| AX-2024-005128 | KP-2312-R4578 | Medutest | 2024-Q2 | 99.10 | 7.46 | 96.2 | Supplier-supplied | 0 | PASS |
| AX-2024-005129 | KP-2312-R4578 | Nordanalyt | 2024-Q2 | 99.29 | 6.49 | — | Supplier-supplied | 0 | PASS |
| AX-2024-005130 | KP-2312-R4578 | Janoshik | 2024-Q2 | 99.57 | 7.31 | 89.1 | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005131 | KP-2312-R4578 | VendorInvestigate | 2024-Q2 | 98.47 | 6.84 | — | Buyer-sourced | 0 | PASS |
| AX-2024-005132 | KP-2312-R4578 | Janoshik | 2024-Q2 | 99.24 | 7.04 | — | Supplier-supplied | 0 | PASS |
| AX-2024-005133 | KP-2312-R4578 | Medutest | 2024-Q2 | 98.28 | 7.26 | — | Laboratory-retained | 0 | PASS |
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.
| Laboratory | Reports | Purity results (% area) | Median | Gradient | Published bias (pp) | Bias-adjusted |
|---|---|---|---|---|---|---|
| Janoshik | 5 | 99.25, 99.50, 98.80, 99.57, 99.24 | 99.25 | 30min | +0.00 | 99.25 |
| Medutest | 3 | 99.36, 99.10, 98.28 | 99.10 | 25min | +0.08 | 99.02 |
| Nordanalyt | 1 | 99.29 | 99.29 | 35min | +0.02 | 99.27 |
| VendorInvestigate | 1 | 98.47 | 98.47 | 32min | -0.11 | 98.58 |
This lot contributes 6 paired comparisons to the inter-lab analysis.
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.
| Figure | Supplier COA | This report | Index note |
|---|---|---|---|
| Purity (% area) | 99.06 | 99.25 | divergence -0.19 pp vs batch median |
| Total impurities (% area) | not stated | 0.75 | |
| Largest single impurity (% area) | not stated | 0.27 | |
| Water (%) | 5.7 | 6.77 | |
| Counter-ion (%) | not stated | 3.99 | |
| Peptide content (%w/w) | 89.5 | 88.75 | |
| Endotoxin (EU/mg) | not stated | 0.36 | |
| Method stated on certificate | NO | — | no method section — the result cannot be reconciled against any other |
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 impurity | Reported in | Median % area | Range |
|---|---|---|---|
| des-Tyr1 (−163 Da) | 10 / 10 | 0.21 | 0.06–0.42 |
| aspartimide (−18 Da) | 10 / 10 | 0.24 | 0.11–0.38 |
| deamidated Asn8 (+1 Da) | 10 / 10 | 0.19 | 0.09–0.48 |
| truncated (1-25) | 10 / 10 | 0.17 | 0.05–0.64 |