New 25-OH-D₃ Feed Standard: Global Alignment, Greater Clarity

Actionable Recommendation

It is strongly recommended to obtain laboratory test results of pure (≥ 94%) 25OHD3 samples from any prospective supplier/manufacturer for the impurities. 

A 1.25% premix may serve as an acceptable sample for initial evaluation of such impurities. However, it is essential to secure laboratory reports for the pure form from the supplier, as FDA regulations apply specifically to the crystalline form.

When evaluating a prospective supplier, consider asking:

• What is the impurity profile for each batch?
• What downstream purification steps are used?
• Can you provide impurity test reports for multiple batches?