Stability Test

Food's "shelf life" will be affected by factors such as the ingredients used, the manufacturing process, the storage, transportation, and sales environment, etc.; storage experiments should be designed and determined according to individual circumstances.

For Taiwan Health Food registration, stability tests of the final product are required to study the influence of environmental factors on the declared health care effect-related components and the quality of the product. The stability test results support or estimate the product's shelf-life (expiry date) and ensure the safety and efficacy it claimed within the expiration date.

Please contact us if you need stability tests for the Health Food registration.

Method Validation
  • Aim

    To validate the analysis method, and prove the applicability of the method and the correctness of the results.

  • Item

    (1) scope / linearity
    (2) specificity
    (3) accuracy
    (4) precision
    (5) limit of detection (LOD) / limit of quantification (LOQ)

Long-term test
  • Aim

    To declare the expiration date of the product, a long-term test is necessary and shall be conducted according the recommended storage conditions of the product.

  • Storage Condition

    (1) General condition: 25±2°C / 60±5% RH
    (2) Refrigeration: 5±3°C
    (3) Freezing: -20±5°C

  • Time Interval

    Expiry date ≤ 6 months:

    Shall include the whole shelf-life. Test time points shall not be less than three times. E.g., 0, 1, 2, 6 months.

    Expiry date > 6 months, ≤ 1 year:

    Test time points shall not be less than five times, in principle, once a month for the first three months and then once every three months until the claimed shelf life. E.g., 0, 1, 2, 3, 6, 9, 12 months.

    Expiry date ≥ 1 year:

    Test time points are in principle every three months in the first year, every six months in the second year, and then every year. E.g., 0, 3, 6, 9, 12, 18, 24, 36, 48… months.

Accelerated test
  • Aim

    Accelerated testing is an experimental design that uses harsher storage conditions to observe chemical degradation and physical changes to evaluate changes in long-term testing in a short period.

  • Storage Condition

    (1) General condition: 40±2°C / 75±5% RH
    (2) Refrigeration: 25±2°C / 60±5% RH

  • Time Interval

    Test time points shall have at least three times.E.g., 0, 3, 6 months.

Open package test
  • Aim

    Suppose the product is to be consumed multiple times within a specific period after opening the package. In that case, at least one batch should be used for opening testing to confirm its stability.

Excursion testing
  • Aim

    To understand the impact of short-term deviation of storage conditions when the product is shipped, use at least one batch of the product to conduct a simulation test of the deviation of the product is advised. The length of the testing time should take into account the maximum value of the simulated deviation state.