Why is BeFisetin™ called the standard of Fisetin?

Part 1- The testing methods of dietary ingredients

Definitely, no one denies the importance of quality in the dietary ingredients industry. The manufacturers, the sellers, the consumers, etc. all care about the quality of dietary ingredients.

While it is easy to tell if a drug or its ingredients(active pharmaceutical ingredient, API) is good or not, we can simply compare its quality to the compendial standard like USP, or EP. It’s hard to tell the quality of a dietary ingredient as an official standard like the compendial standard is usually not established.

What makes the standard of a dietary ingredient?

Like API, the standard of a dietary ingredient typically includes:

1.Identification

An identification test is also called a qualitative test, which confirms an ingredient is real. IR, NMR, TLC, and HPLC, etc., are the common technologies for identity. The sample is usually compared with a Reference Substance.

Samples of our qualitative tests

2.Purity/impurities

Purity focuses on the active component, which exerts functions in the human body. And the impurities include relative components(organic impurities), inorganic impurities, residual solvents, heavy metals, microorganisms, etc.

Usually, the impurities are the unwanted parts of the ingredients but they’re not easily to be removed. Sometimes the impurities are inactive ingredients but sometimes they cause side or toxic effects. So their amounts should be strictly limited.

HPLC is the most common test for this item. The detection wavelength(range), column type, mobile phase, elution, etc., are the key factors. In this test, the total detected area is normalized to 100% and the portion of the detected area of the main peak(TDA%) stands for the purity of the ingredient. No external standard is required.

3. Assay

Unlike the purity test, Reference Standard(RS) is used as an external standard in the assay. Assay is usually more reliable to judge the quality of a dietary ingredient. An RS will directly influence the results but it’s hard to apply an RS when a compendial RS from USP, or EP is not available.

Besides the above tests, other tests like water determination are included in the standard as well.

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