Sermorelin — batch VL-2705-C
Issued by Northlake Analytical, LLC, an independent testing laboratory contracted by Verolyn Labs. This document is published in full and is not edited after issue.
| Product name | Sermorelin |
|---|---|
| Batch number | VL-2705-C |
| Molecular formula | C₁₄₉H₂₄₆N₄₄O₄₂S |
| Molecular weight | 3357.88 g/mol |
| Observed mass (LC-MS) | 3358.1 m/z |
| Declared mass per vial | 5 mg |
| Appearance | White to off-white lyophilised cake |
| Test | Specification | Result |
|---|---|---|
| Purity (RP-HPLC) | ≥ 98.0% | 99.0% |
| Identity (LC-MS) | Conforms | Conforms |
| Water (Karl Fischer) | ≤ 8.0% | 4.8% |
| Acetate content | ≤ 12.0% | 9.1% |
| Bacterial endotoxin | ≤ 1.0 EU/mg | < 0.25 EU/mg |
| Single largest impurity | ≤ 1.0% | 0.3% |
Method conditions
Purity. Reversed-phase HPLC, C18 column, gradient elution with 0.1% TFA in water and acetonitrile, UV detection at 214 nm. Purity reported as main peak area over total peak area.
Identity. Liquid chromatography–mass spectrometry, electrospray ionisation, positive mode. Identity is confirmed where the observed mass agrees with the theoretical mass within instrument tolerance.
Water content. Coulometric Karl Fischer titration.
Endotoxin. Kinetic chromogenic LAL assay.
Release statement
The batch identified above was sampled at random across the production lot and analysed under the conditions stated. All tested parameters fall within the specifications listed, and the batch is released for distribution as research material.
Store lyophilised material at −20 °C, protected from light. Certificate values apply to the material as supplied and as stored under those conditions.
Research use only
This certificate describes material supplied for laboratory research. It is not a specification for use in humans or animals, and it makes no statement about biological effect.