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.
 

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.
 

For a dietary ingredient from a plant, the origin should be an essential part of a standard.
 

Here we take a plant-extracted, Fisetin, as an example to illustrate the standard of a dietary ingredient.
 

Of course, we will start from the plant origin.

Fisetin is naturally present in many plants including strawberries, apples, and grapes. The use of Fisetin dates back to thousands of years ago and it was first isolated in 1833.

To select the right plant source for Fisetin extraction, we retrieved and studied the literature thoroughly. Rhus Cotinus L.(Smoketree) is the most studied source for Fisetin. What a coincidence, it has a long history of traditional medical use in China and Europe.

Smoketree grows widely in Asia and Europe but the traditionally used part of smoketree is its trunk. However, sustainable and eco-friendly development is Bonerge’s commitment. To extract Fisetin from branches instead of trunks, a series of studies are conducted at Bonerge for years.

Now all the Fisetin ingredient from Bonerge is extracted from leaves and branches.

 

 

★ Identification

LC-MS, IR, NMR, etc. are applied to confirm the molecular weight and chemical structure of Fisetin.

 

 

★ Purity/Impurities

The validated HPLC method is applied at Bonerge to determine the purity of Fisetin. Other methods like LC-MS are used to identify its impurities.

 

★ Assay

Since no official RS is available, Bonerge sourced Fisetin RS globally and finally chooses a reputable German Standard-Phyproof® as its external standard.

A trusted RS is like an impartial judge. While some suppliers use purity to mislead consumers intentionally, their Fisetin touted 98% purity might be less than 80% in assay.

 

★ Other Testing We Conducted

Bonerge is aiming to offer premium-quality ingredients with potent healthy values to the world. With the help of modern instrumental analysis technology, we carried out all the necessary analysis for our BeFisetin to make sure our fisetin Be Fisetin.

 

 

Following compendial guidelines, Bonerge develops Befisetin™, the standard for Fisetin. With its slogan to be the standard of Fisetin, Befisetin™ will always be on the way to a higher standard of Fisetin.

BeFisetin™, is born to be the real high-quality Fisetin.

 

Some brand owners may feel cheated by their suppliers, and some consumers are deceived by brands. You can not tell the difference between superior and inferior ingredients by their appearance.

But imagine one day, you can tell the Fisetin is of top quality because BeFisetin™ is on the label and inside the bottle.