Stability studies ensure the durability of our Certified Reference Materials according to ISO Guide 35:2017 requirements to guarantee the satisfaction of our customers.

Homogeneity and stability are two key features of any Certified Reference Material (CRM). ISO Guide 35:2017 specifies that a CRM must include at least three characteristics:

  • Homogeneity assessment
  • Stability Study
  • Characterization

The overall uncertainty of CRM was evaluated by combinig the contributions from qNMR characterization, sample preparation, homogeneity and stability.

Given its high accuracy, precision, and reproducibility, UPLC-MS/MS is the chosen technique for stability determination of CRMs.

The objective of a stability study is to determine the time during which a CRM or QCS product meets appropriate standards when stored under defined conditions.

The product must be shown to remain within its expiry specifications throughout the proposed shelf life when stored under the proposed storage conditions.

Therefore, it is crucial for the preparation, distribution, storage, and application of solution CRMs to investigate the stability of toxins solution under various conditions. The long-term stability of the material (i.e. the stability of the material during the period of validity under specified storage conditions); the short-term stability under reasonably expected conditions of transport. 

Preparing a stability study